Intervention - Nutritional Care Models

Collation of Nutrition and HIV Studies for the Standing Committee for Nutrition, Geneva Food and Nutrition
Technical Assistance Program (FANTA) Academy for Educational Development April 20, 2006 The following list of on-going food and nutrition studies was based on respondent information and is subject to change. Please provide updates or new studies to Bruce Cogill at bcogill@aed.org
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Neil Jarvis IAEA. Using Isotope Techniques to Assess Nutrition Intervention Programmes Related to HIV/AIDS in Africa. Mark Manary Univ. Washington, St. Louis. Randomized controlled trial comparing the impact of nutrition counseling and supplementary feeding with either RUTF or CSB among wasted adult ART clients in Malawi. Elizabeth Kamau-Mbuthia, University of Vienna/Egerton University, Prof. Ibrahim lmadfa, University of Vienna, Austria The impact of maternal HIV status on infant feeding patterns and growth in Nakuru, Kenya. RENEWAL Kenya: Elizabeth Byron, Consultant (IFPRI) The Impact of a Nutrition Program for People Living with HIV and its Role in Household Response. Kenya RENEWAL Zambia; Petan Hamazakaza, RENEWAL, HIV/AIDS and Community Resilience in Zambia: Understanding the Implications for Food and Nutrition Policies. RENEWAL Malawi: Pauline E Peters The Effects on Rural Livelihoods of HIVrelated Illness & Death in Zomba, Malawi: a longitudinal study RENEWAL South Africa: Wayne Twine HIV/AIDS Mortality and the Role of
Woodland Resources in the Maintenance of Household Food Security in a Rural District of South Africa RENEWAL Regional 1: Virginia Bond Tuberculosis: An Additional Tipping Stress on Poor Households in South Africa and Zambia. RENEWAL Regional 2: Bruce Frayne RENEWAL Migration, HIV/AIDS and Urban Food Security in Southern and Eastern Africa ILRI Campus Addis Ababa, Ethiopia
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Anne S.W. Mburu (PI); David L. Mwaniki Centre for Public Health Research; Kenya Medical Research Institute, Nairobi, Kenya The Effects of Multimicronutrient Supplements And Food Rations On The Nutritional Status And Health Of HIV-Positive Adults. UNICEF courtesy of funding from the Dutch Government Fathia Abdalla, Paul Spiegel, Gebrewold Petros, UNHCR; Implementation of program strategies to integrate HIV/AIDS and nutrition activities in refugee settings in Uganda and in Zambia.
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Dr. Robert Kabumbuli, Department of Sociology, Makerere University. Land ownership and food security in Uganda: A Study of the use and control of land among household of women affected by HIV/AIDS in four districts. IFPRI Susan Thurstans, Action Against Hunger Malawi. A pilot programme to assess the impact of treating acute malnutrition on mortality in adults and adolescents starting ARV therapy in Malawi with UN funding. Steve Collins and Paluku Bahwere, Valid International. Acceptability and effectiveness of nutrition support with a Chickpea-Sesame based Ready-to-UseTherapeutic Food (CS-RUTF) in chronically sick adults delivered through a home based care (HBC) program Steve Collins, Valid International. Integrating HIV services into a Community Therapeutic Care (CTC) program in Malawi: an operational research study. VALID, SARA/FANTA. Marko Kerac, Steve Collins, VALID International. Moyo RUTF Study: A randomised controlled trial to compare the efficacy of three new formulations of Ready-to-Use Therapeutic Food (RUTF) in the treatment of severe acute childhood malnutrition (HIV positive and HIV negative children).
Paul Bukuluki RENEWAL Gender dimensions in food/nutrition security and HIV/AIDS in Internally displaced peoples camps in Uganda Makerere University Ann Strauss INIPSA A Nutrition Intervention within a comprehensive ART care package with an Impact Evaluation Benin, Burundi Mali WFP.
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Prof. Maniki and FANTA: Randomized controlled evaluation of the impact of food
supplements on malnourished HIV-infected adult ART clients and malnourished, HIVinfected pre-ART adults in Kenya.
No. 1
Operations Research on Food/Nutrition and HIV and AIDS 21 February 2006 Complete one table per study Respond by Friday 3 March, 2006 to bcogill@aed.org 1. Your Name, Contact Information & Date Programme Management Officer: Neil Jarvis (n.jarvis@iaea.org) Technical Officer: Najat Mokhtar (n.mokhtar@iaea.org) International Atomic Energy Agency (IAEA) 27 February 2006 Using Isotope Techniques to Assess Nutrition Intervention Programmes Related to HIV/AIDS in Africa (Project RAF/7/006) IAEA Technical Cooperation Fund US$ 1.1 million Participating countries having obtained national ethical clearance: 1. Botswana National Food Technology Research Centre Principal Investigator has changed we await nomination of new PI. 2. Cameroon Centre for Food and Nutrition Research Ms. Marie-Thrse Garba 3. Ethiopia Ethiopian Health and Nutrition Research Institute (EHNRI) Mr. Habtamu Fufa 4. Ghana Ghana Atomic Energy Commission (GAEC) Ms. Rose Boatin 5. Senegal Universit Cheikh Anta Diop de Dakar (UCAD) Prof. Salimata Wade 6. Uganda TASO/Ministry of Health Ms. Christine Nabiryo 6. United Republic of Tanzania Tanzania Food and Nutrition Centre Dr. Godwin Ndossi Participating countries working towards national ethical clearance:
2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s)
1. Kenya
University of Nairobi Ms. Christine Mwangi 2. South Africa University of KwaZulu-Natal Prof. Anna Coutsoudis 3. Zambia National Institute for Scientific and Industrial Research (NISIR) Ms. Rodah Zulu 4. Zimbabwe Ministry of Health and Child Welfare (MOHCW) Ms. Rufaro Madzima WHO/AFRO Started 2004- final report by 2008 To assess the efficacy of food-based national strategies that promote intake of essential nutrients using isotope-based techniques on HIV-infected vulnerable groups using isotope techniques; and to provide evidence for policy decisions Nutrition plays a critical role in health care and support for people living with HIV/AIDS (PLWHA). Nutritional interventions can help in managing symptoms, promote response to medical treatment, slow progression of the disease, and increase the quality of life by improving daily functioning. Several countries in Africa are initiating nutrition interventions based of food supplementation. The aim of this project is to evaluate these interventions and assess their efficacy.
5. Partners in study 6. Duration/Timeline 7. Objectives
8. Rationale for study
9. Study question(s) 10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
Does the supplemented food increase body lean mass of PLWHA? Efficacy study, self controlled, community based In response to several requests from Member States implementing nutrition intervention programmes for PLWHA, project RAF/7/006 is providing equipment, expert services and training related to the use of isotopic techniques to assess the efficacy of the national programmes. The following criteria relate to the inclusion of the participant in the study and not to access to the food being provided under the intervention campaign. Efficacy study with separate control groups or participant selfcontrol as appropriate to the local situation; Sample size per group at baseline data collection stage: minimum of 100 to allow for sufficient data at the end of the study given that attrition is expected; Community based; On-site (controlled) feeding/food rations or directly observed by community based workers as appropriate for local conditions;Age of
participants: 18 - 45 years with equal number of males and females if possible; BMI less than 25kg/m3; Sero-positive participants classified at clinical stage I, II or III of the WHO staging system for HIV infection; CD4 greater than 200 cell count/mm3; Participant consent.
The following criteria relate to the exclusion of the participants in the study and not to access to the food being provided under the intervention campaign. Pregnant women Those under 18 and above 45 years; CD4 below 200 cell counts/mm3; Sero-positive participants classified at clinical stage IV or advanced Stage III of the WHO staging system for HIV infection; Mentally challenged;
13. Outcome measures
14. Location of Study 15. Published reports (website if available) 16. Expected date of final report/ publications 17. Additional Comments
Bed-ridden; Anyone already consuming any form of nutritional supplement Performance indicators 1. Data on body composition/nutritional status of PLWHA, according to study designs in at least four participating countries, collected and analyzed by December 2007. 2. Completion of reports to be submitted to health sector decision-makers in at least four participating countries by December 2007. Community based in participating countries None as yet. End 2008
No. 2
Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Information & Date 2. Research Study Title Bruce Cogill, FANTA Project/AED; bcogill@aed.org 23 February, 2006 Randomized controlled trial comparing the impact of nutrition counseling and supplementary feeding with either RUTF or CSB among wasted adult ART clients in Malawi USAID (PEPFAR) FANTA Project/AED, Washington Univ. St. Louis, Univ. Malawi Mark Manary, Washington Univ. St. Louis
3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives
FANTA Project/AED, Washington Univ. St. Louis, Univ. Malawi Start January 2006 Final Report December 2007 Publication 2008 Compare the impacts of supplemental ready-to-usetherapeutic food (RUTF) to the impacts of corn soy blend (CSB) on nutritional/clinical outcomes and overall quality of life among wasted adult antiretroviral therapy (ART) clients in Malawi In order to strengthen the evidence base about the impacts of food supplementation on the nutritional and clinical status of HIV-infected individuals, FANTA is working with local partners to conduct a targeted evaluation of specific therapeutic food on adult subjects taking ARVs. What are the health, nutrition and quality of life benefits of food supplementation for wasted adult receiving regular ART in Malawi Random assignment of treatment with RUTF and nutrition counseling Subjects will be randomly assigned to receive one of two interventions (225 in each group): Group I: 260 g/d of RUTF and nutrition counseling, or Group II: 374 g/d of CSB and nutrition counseling RUTF is produced locally in accordance with Nutriset specifications (Plumpynut) and the CSB procured from the US and follows the World Food Programme formulation. The two food products are designed to provide 45% of the daily estimated average requirement for energy. ARVs and RUTF provided at ARV therapy clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi. The food will be distributed monthly in conjunction with a followup visit. All participants will receive the standard nutritional counseling for healthy eating with HIV.
9. Study question(s)
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs
12. Describe intervention delivery mechanisms used in the study. That is, how was the
intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)?
14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
16. Location of Study 17. Published reports (website if available)
Data include a history of current clinical symptoms (fever, cough, vomiting, appetite and diarrhea) and their duration will be elicited, as well as any medications or other medical diagnoses. Questions to determine the compliance with the ART will be asked, as well as pill counts made, once subjects have started ART. A focus group interview will be conducted with a subset of randomly selected individuals from each of the two groups to explore alternative uses of the food and sharing of the food within the household. total 450 Eligible subjects will be adults (> 18 years old) diagnosed with AIDS and scheduled to begin treatment with ART within 3 months with a body mass index (BMI) of < 18.0. All women who say that they are pregnant or lactating will be excluded. Subjects will be recruited from individuals attending the ARV therapy clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi under the supervision of physicians of the Internal Medicine Department, College of Medicine, University of Malawi Basic socio-demographic data will be collected; such as birth date, age, sex, address, occupation, and measures of economic status. A quality of life assessment will be administered. Data on subjects nutritional status (BMI, BIA, and serum albumin), clinical status (viral load, CD4 count, clinical events), quality of life, and adherence to ARV drugs will be collected for the three months of supplementation and for nine months of follow-up. Communities around the Queen Elizabeth Central Hospital in Blantyre, Malawi N/A
18. Expected date of final report/ publications 19. Additional Comments
December 2007 with publication in mid-2008
Institutional Review Board approval in US and Malawi completed.
No. 3
Operations Research on Food/Nutrition and HIV and AIDS 23 February 2006 1. Your Name, Contact Information & Date 2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives Elizabeth Kamau-Mbuthia, University of Vienna/Egerton University, ekambu@yahoo.com, Feb 2006 The impact of maternal HIV status on infant feeding patterns and growth in Nakuru, Kenya North-South-Dialogue scholarship program-Austria Doctorate studies University of Vienna Elizabeth Kamau-Mbuthia
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 13. Outcome measures
Prof. Ibrahim Elmadfa, University of Vienna, Austria Data collection-Feb 2004-July 2005, final report in March 2006 and publications thereafter. Assess maternal (HIV infected and uninfected) nutritional status during pregnancy and when lactating, birth outcomes, infant feeding patterns and growth from birth to fourteen weeks. To assess the kind of feeding patterns that mothers of known HIV status are using for their children and the effects this is having on infant growth and whether they actually adhere to infant feeding practices as recommended. Is maternal HIV status having an effect on infant feeding patterns adapted and are these choices having an effect on infant growth, are mothers adhering to infant feeding recommendations? Longitudinal and observational No interventions put in place in this study but the mothers recruited were going through the PMTCT of HIV program at the Provincial General Hospital,Nakuru, Kenya where they received counseling on HIV related issues and general health and nutrition. Some also received nutrient supplements. 280 pregnant women recruited at beginning of study. Women who went through PMTCT program at the hospital and knew their HIV status, age ranged 15-40 years. Followed from pregnancy through delivery and with infant upto fourteen weeks during immunization clinics. Sociodemographic data of HIV infected and uninfected (acting as controls) women, their nutritional status through anthropometry and dietary intake. Infant feeding patterns and growth at intervals from birth, 6, 10, 14 weeks. Association between maternal nutritional status and infant feeding pattern and growth by fourteen weeks. Provincial General Hospital, Nakuru, Kenya N/A
14. Location of Study 15. Published reports
(website if available) 16. Expected date of final report/ publications 17. Additional Comments
March 2006
Approved by The ministry of Education, research section, Kenya and the hospital administration.
No. 4
RENEWAL-Kenya
1. Your Name, Contact Information & Date 2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) Elizabeth Byron, Consultant (IFPRI), e.byron@cgiar.org, February 2006 The Impact of a Nutrition Program for People Living with HIV and its Role in Household Response 1. RENEWAL-Kenya - $47,091 2. USAID-Food For Peace funding for Post Doctoral Consultant Mabel N. Nangami, Dept. of Health Management, Moi University, Kenya Elizabeth Byron, IFPRI Abraham M. Siika, Dept. of Medicine, Moi University, Kenya Kara Wools-Kaloustian, Indiana University School of Medicine Stuart Gillespie, IFPRI Markus Goldstein, The World Bank Joshua Graff-Zivin, Dept. of Health Policy and Management, Columbia University Cristian Pop-Eleches, Dept. of Economics and SIPA, Columbia University Moi University, AMPATH, Indiana University School of Medicine, International Food Policy Research Institute (IFPRI), Columbia University, The World Bank December 2005 to Sept 2006 To understand how provision of ARVs and nutritional support interact to mitigate health and economic impacts of HIC at the patient, household and community level and assess how such nutritional support programs influence pre-existing informal support networks within the community. Reconstitution of the immune system after initiation of antiretroviral treatment is associated with an individuals nutritional status and subsequent dietary intake. The goal of this study is to examine the ability of nutritional interventions to improve both the nutritional status of ARV patients and the resilience of their households in the context of pre-existing social support networks. 1. Which households do better at maintaining nutritional status in the face of the onset of AIDS and which factors are associated with this? 2. What are the food distribution and allocation patterns within these households between the HIV patients and their children? 3. Who provides transfers to HIV patient households and how does support change through the course of disease and treatment? 4. Do the food supplements buffer any deleterious impacts on household nutrition, educational attainment, income, and labor supply? 5. What, if any, are the community level impacts? 6. How sustainable is this approach and what are the implications for scaling up the program? Combination of clinical data, socioeconomic household survey, and in-depth qualitative research methods. Sample is patients and households in the catchment area of the Mosoriot Rural Health Center in Kosirai Division. WFP provides 50% of RDA to eligible patients on ARVs and their household members for period of 6 months. Eligibility is determined by BMI below 19, CD4 count below 200, and insufficient access to food to support patient recovery. Intended for patients starting ARV treatment after June 2005. HAART and Harvest Initiative (HHI) provides locally grown fresh foods (dairy, eggs, vegetables) to wider range of patients on ARVs in addition to
5. Partners in study
6. Duration/Timeline 7. Objectives
10. Study Design
11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs
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those receiving WFP supplements. Intended for patients on ARVs since 2002 who qualify and as supplement to WFP food basket. Nutrition education and counseling provided to all ARV patients at clinic regardless of participation in nutrition supplement program. Patients collect food at weekly, and monthly intervals depending on distance from distribution sites. Intervention is delivered as part of ARV treatment program through health clinic. The nutritionist writes a nutritional prescription for each patient each month and then the patient takes this to the supplement collection points. There are 5 distribution sites located throughout the patient catchment area where patients or a designated caregiver report to collect the nutrition supplements at weekly or monthly intervals. The nutrition supplements are free, but patients are responsible for transport to collect the food. Many collect food on the same day as their clinical checkups. Patients enrolled in food program after June 2005 and eligible for food receive both WFP and HHI foods. Patients enrolling in program prior to June 2005 are eligible for HHI food only. Key informant interviews with program staff involved with the intervention were conducted. There may be analysis of collection records with the clinical data in the future, none at this time.
12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
16. Location of Study 17. Published reports 18. Expected date of final report/ publications 19. Additional Comments
In-depth research: 20 Key informants, 9 focus group discussions, and 80 individual patient interviews. Survey: 862 households Clinical data: approximately 1000 patients total from 4 groupings below. Group 1 Patients starting ARVs June Dec 2005 and enrolled in food supplement program Group 2 Patients starting ARVs June Dec 2005, but not in food supplement program Group 3 Patients starting ARVs June 2004-Jan 2005 and at one time receiving HHI food. Group 4 Patients starting ARVs June 2004-Jan 2005 but never receiving any food from program. Pairwise comparisons between patient groups (food and non-food) involving continuous outcome measures using a t-test. Compare CD4 counts from baseline to 6 months for newly enrolled ARV patients, nutritional status (BMI) and comparison of rate of occurrence of opportunistic infections, drug toxicity, adherence, mortality, and loss to follow-up. Build on 3 rounds of panel dataset Mosoriot Rural Health Center and catchment area, Kosirai Division, western Kenya Not yet available Qualitative data report by August 2006 Household Survey report by December 2006 Clinical Data analysis by November 2006 Study is ongoing. Qualitative fieldwork completed Feb 28, 2006. Survey to begin mid-March 2006 and run through Sept. 2006. Clinical data are currently being collected through patient electronic medical records system and analysis to begin in June 2006.
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No. 5
RENEWAL Zambia 1. Your Name, Contact Information & Date 2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) Petan Hamazakaza, RENEWAL, c/o Zambia Agriculture Research Institute, Box 630090, Choma, Zambia; fcdp@zamnet.zm, March 1, 2006 HIV/AIDS and Community Resilience in Zambia: Understanding the Implications for Food and Nutrition Policies RENEWAL- $ 43,344.00 MSU-FSRP training and staff time IFPRI Staff time Petan Hamazakaza (ZARI) Elizabeth Byron (IFPRI) Mukelabai Ndiyoii (FASAZ) Albert Chalabesa (MACO-ZARI) T.S. Jayne (MSU- FSRP) Stuart Gillespie (IFPRI) Suneetha Kadiyala (IFPRI) Farming Systems Association of Zambia (FASAZ), Zambia Agriculture Research Institute (ZARI), International Food Policy Research Institute (IFPRI), MSU Food Security Research Project (FSRP), Ministry of Agriculture and Cooperatives (MACO) February 2005 to May 2005 (Fieldwork) The overall goal of this study is to enhance local policy makers understanding of the ways in which key Zambian food security and nutritionrelevant policies and programs may need to be modified so as to strengthen the resistance and resilience of rural farming households and communities to HIV/AIDS without sacrificing the contribution of such policies and programs to other national objectives. Specific objectives follow: Understand the what determines household and/or community level resistance to HIV infection; Understand how households and communities affected by HIV/AIDS responded to livelihood shocks such as livestock disease, the 2002 drought and the subsequent food crisis and how this differed from those relatively less affected by HIV/AIDS Assess why some communities display resilience to the AIDS disease despite relatively high levels of prime-age adult mortality and current chronic illness while other communities do not Identify strengths and weaknesses of community-level institutions with regard to their ability to respond to HIV/AIDS Elucidate the pathways through which a selection of key food security and nutrition-relevant policies and programs strengthen or weaken household and community resistance and resilience to HIV/AIDS. Formulate an advisory note for policy makers based on research findings and policy review processes. Until recently, national policy makers in Zambia and many other countries in the region have tended to view HIV/AIDS as a problem for the Ministry of Health and the broader health community to address. Yet it is becoming increasingly clear that policies and programs in other sectors, such as those under the purview of the Ministries of Agriculture and Cooperatives, and Trade and Industry, may have unintended effects on the spread of HIV/AIDS and the ability of households and communities to withstand the hardships caused by the disease.
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What are the characteristics of households and communities that have low HIV prevalence rates (as measured by adult mortality due to chronic illness and current chronic illness), especially those with significant levels of other known determinants (i.e. positive outliers)? How do rural households and communities affected by HIV/AIDS respond to food production shortfalls, and how do these households and communities differ in their responses from non-afflicted rural households and communities? The study will attempt to learn about differential responses to the 2001/02 food crisis in Zambia as a specific case, although the study aims to review more broadly the Zambian agricultural and food security-related factors affecting rural household and community responses to the HIV/AIDS pandemic. What are the ways in which existing community-level capacities are mobilized in response to HIV/AIDS and are there capacity gaps or weaknesses that may have constrained the effectiveness of these responses? What are the major institutional and policy factors that affect community resistance and resilience to the HIV/AIDS pandemic? Study conducted by multi-disciplinary team; anthropologist, nutritionists, economists and agronomists. Selected study area which is agricultural based, but experiencing worst livelihood impacts (drought, livestock diseases, ) Selected four communities all of which had adult mortality higher than provincial HIV prevalence. Data collection comprised of quantitative interviews for 45 50 households in each community, focus group discussions with gender disaggregated groups (men, women and combined men and women group), key informant interviews and also 15 in-depth case studies in each community for shocked households (i.e. death, chronic illness, fostering orphans, widow headed)The study focused on four rural communities, stratified by prime-age adult mortality rates and indicators of community resilience. We conducted a quantitative household survey to a total of 179 households and followed up 60 of the households with qualitative in-depth interviews. We also held community meetings and discussions. N/A
10. Study Design
11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)?
N/A
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13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 15. Outcome measures 16. Location of Study
Household Survey includes data on participation in Government of Zambia Food Security and Social Welfare Programs (Fertilizer Support Program, Food Security Pack, and Social Welfare Program)
179 household surveys 60 in-depth follow up interviews from 4 rural areas in Southern Province.
17. Published reports (website if available) 18. Expected date of final report/ publications 19. Additional Comments
Southern Province: Pemba area in Choma district, Garner Farm/Musikili area in Mazabuka district, Banamwaze chiefdom in Itezhi tezhi, Makunka area in Kazungula district. Paper presented at ASSA in December 2005 First report to be published on www.ifpri.org/renewal/index.htm in June 2006 June 2006 Study is complete and in analysis phase.
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No. 6
RENEWAL Malawi 1. Your Name, Contact Information & Date 2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives Pauline E Peters; Malawi contacts: ppeters@sdnp.org.mw; 01 525 122; 09 640 833 The Effects on Rural Livelihoods of HIV-related Illness & Death in Zomba, Malawi: a longitudinal study IFPRI RENEWAL $46,500 + Fulbright-Hayes $6000 (field expenses) + Kennedy School, Harvard $4000 Harvard University and Chancellor College, U of Malawi (Peters); Bunda College of Agric, U of Malawi (Daimon Kambewa); U of Oregon (Peter Walker) University of Malawi January-December 2006 To investigate shifts and persistences in household composition, livelihood strategies, expenditures, access to land, social networks, and community organization consequent on increased morbidity and mortality related to HIV/AIDS among households, families and villages originally studied in 1986. The main rationale is the unusual ability to provide a before and after assessment of the effects of rising deaths and chronic illness on rural families. And thereby, to provide assessment and possible amendment to current interpretations of and actions taken in response to rising death and illness. What changes or persistences are seen in agricultural production patterns, access to land, income and expenditure levels and patterns, anthropometric measures, social networks, access to services, etc. A combination of questionnaire-based surveys to provide quantitative data and ethnographic or qualitative study. The methods are those used in the baseline study of 1986 and subsequent restudies in 1990 and 1997. None
10. Study Design
11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)?
None
n/a
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14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 15. Outcome measures 16. Location of Study 17. Published reports (website if available) 18. Expected date of final report/ publications 19. Additional Comments
Total sample for 2006 is 250 households but the number present since 1986 is 175 (+ 6 or 7 daughter hhds formed by 1/2006). No testing is done so proxy for HIV-related illness are statements by the individual/family, and/or symptoms. See 8 above Zomba South, Malawi none After June 2007 IRB approval from Harvard University and approval by University of Malawi review board
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No. 7
RENEWAL South Africa 1. Your Name, Contact Information & Date Wayne Twine School of Animal, Plant & Environmental Sciences University of the Witwatersrand (South Africa) Tel: +27 15 7937500 Fax: +27 15 793 7509 rcrd@global.co.za 02 March 2006 HIV/AIDS Mortality and the Role of Woodland Resources in the Maintenance of Household Food Security in a Rural District of South Africa. RENEWAL/IFPRI
2. Research Study Title
3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s)
Wayne Twine: School of Animal, Plant and Environmental Sciences, University of the Witwatersrand (South Africa) Lori Hunter: Institute for Behavioral Sciences, University of Colorado at Boulder (USA) Wits-MRC Agincourt Health and Population Unit, University of the Witwatersrand (South Africa) South African National Department of Water Affairs and Forestry 2006-2007 To examine food security among HIV-impacted households in rural South Africa (as compared to non-HIV-impacted households) with a particular focus on the role of woodland resources (e.g. wild foods) in shaping household resilience or vulnerability following the death of a prime-age adult. Although woodland resources (also referred to as non-timber forest products (NTFPs)) are a standard dietary component in Africa (Gockowski et al 2003; Shackleton et al. 2000; Steyn et al. 2002; Twine et al. 2003), few data exist on the specific role of these resources in the maintenance of household food security among HIV-impacted households (Barany et al. 2001). In this context, it is also unknown what the influence might be of cash savings or income generated through the use or sale of woodland resources as coping strategies (e.g. using fuelwood instead of paraffin or electricity to be able to afford to buy food). Indeed, to-date the environmental dimensions of the HIV/AIDS pandemic remain little explored, despite the centrality of the natural environment in the livelihoods of the rural poor across Africa. As pointed out by Hammarskjold (2003:6), What has been published hitherto on the subject is therefore based on fragmentary and anecdotal information. It is important that this information gap be addressed, given that subSaharan Africa is generally typified by the interlinked phenomena of rapidly rising rates of HIV infection, high levels of food insecurity, high dependence on natural resources for rural livelihoods, climatic variability and environmental degradation (Barany et al 2001; Holden & Shiferaw 2004; Misselhorn 2005). Nowhere is this more urgent than in southern Africa, which has the highest rates of HIV infection in the world (UNAIDS 2004). 1) What role do woodland resources play in contributing to household food security following the death of a prime-age adult due to AIDS?
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10. Study Design
Are otherwise similar HIV-impacted households more food secure if they have better access to local woodland resources? 3) How do poverty, poor availability of local woodland resources and the death of a prime-age adult interact to shape household vulnerability to food insecurity? There are 4 data sources proposed for this examination. Data Source #1, Ongoing Demographic Surveillance System: Insight into the demographic characteristics of Agincourt residents will be provided through the Wits-Medical Research Council Agincourt Health and Population Units (AHPU) longitudinal health and demographic surveillance system (HDSS). Since 1992, the AHPU has collected census data at 12-18 month intervals from all 11,000 households in the Agincourt sub-district. The resulting data are incredibly rich in demographic and socio-economic detail, allowing identification of key household characteristics (e.g., size, male/female headship, age composition, socio-economic status). Data Source #2, Quantitative Survey: We aim to survey 300 households in a maximum of 10 villages within the Agincourt field site, in order to collect data on food security, adaptive livelihood strategies and on household use of woodland resources. Data Source #3, Qualitative Interviews: Following preliminary analyses of the first half of the survey data (data source#2), we will undertaken 30 indepth, qualitative interviews to supplement the quantitative insights, and suggest any additional data needs for the remainder of the data collection effort. Data Source #4, Remote Sensing and Ground-Truthing: Ecosystem status and local availability of natural resources around study villages will be assessed using remotely sensed data (satellite images and aerial photographs). These data will be ground-truthed by quantifying the vegetation cover and structure using accepted ecological field methods. We aim to sample 300 households with the quantitative survey. We will select our survey sample based on the two central dimensions of 1) mortality experience in last two years and 2) local availability of woodland resources. Mortality strata to be used are a) HIV mortality, b) non-HIV mortality and c) no mortality (of prime-age adults). We plan to sample non-HIV mortality households since we will not able to directly address the question of HIV morbidity in this study. More specifically, by comparing households with HIV and quick non-HIV deaths (such as heart attack or motor vehicle accident), we hope to be able to indirectly capture some of the unique impacts of HIV mortality, which include a preceding long period of illness. Recall that poverty represents another dimension of vulnerability examined within this research. That said, we will not stratify the study population based upon this dimension, since variation representative of the population can be expected to occur within the sample. Socio-economic status (SES) from wealth ranking will be obtained for households from the Agincourt Health and Population Units database. Wealth ranking is based on household ownership of assets (e.g. appliances) and access to services and amenities (e.g. a water tap in the yard). Stratification by SES will occur during analysis phase of the study. This study will not have direct intervention inputs. Rather, it is aimed at generating new information to inform policy. To this end, we have partnered with a national government department to help facilitate the effective and appropriate flow of information to policy makers. We will also partner with the Agincourt Health and Population Unit in communicating research findings
2)
18
12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 15. Outcome measures 16. Location of Study
back to the local community and government structures in the study site. It is envisaged that feedback to national policy will be in the form of workshop meetings and a policy brief, facilitated by our government partner. Communication of results and lessons learnt to the local structures will be via the Agincourt Health and Population Units existing community feedback mechanisms, which include community meetings, research result fact sheets, and a community research forum.
NA
NA
17. Published reports (website if available)
NA The study site comprises the Agincourt sub-district of the Bushbuckridge rural municipality, in the far north-east of South Africa. This border region previously fell under Limpopo Province, but has recently been transferred to Mpumalanga Province. The field site, named after one of the local villages, consists of 21 villages, comprising over 11,000 households and 67,000 people. Village population size ranges from 480 to 6,834. The area is typical of rural communities across South Africa, and is characterised by poverty, high human densities, and a high reliance on natural resources, on remittances from a large migrant population, and social security grants. Previous reports from a CICRED-funded project also dealing with HIV/AIDS and resource use: 1. Hunter, L.M. & Twine, W. (2005) Adult mortality, natural resources and food security: evidence from the Agincourt field site in rural South Africa. Working Paper EB2005-0001, Environment and Behavior Research Program, Institute of Behavioural Sciences, University of Colorado Boulder (USA). http://www.colorado.edu/ibs/pubs/eb/eb2005-0001.pdf 2. Hunter, L. M., Twine, W & Johnson, A. (2005) The Role of Natural Resources in Coping with Household Mortality: An Examination in Rural South Africa. IBS Working Paper: EB2005-0004: http://www.colorado.edu/ibs/pubs/eb/eb2005-0004.pdf
December 2007 NA
19
No. 8
RENEWAL Regional 1 1. Your Name, Contact Information & Date 2. Research Study Title Virginia Bond, Tel: 260 1 97 846 726, gbond@zamsaf.co.zm, 1 March 2006 Tuberculosis: An Additional Tipping Stress on Poor Households in South Africa and Zambia RENEWAL, IFPRI US$110,000
st
3. Optional Funding source(s) and level of funding 4. Name of Organization ZAMBART Project, Zambia (Lead) and Principal Investigator(s) Desmond Tutu TB Centre, Stellenbosch University, SA 5. Partners in study
Principal Investigator: Virginia Bond District, provincial & central health authorities in Zambia and Western Cape ZAMSTAR clinical trial funded by Bill & Melinda Gates Foundation, 20042010, CREATE Consortium March 2006 August 2007 Anthropological research to detail impact of convergences of TB, food insecurity and HIV at household level in one rural community (Zambia) and one peri-urban community (Western Cape) To address emergent phenomena of rural tuberculosis and the advanced HIV epidemic with an inbuilt comparison between Zambia and South Africa from perspective of households (with urban-rural linkages) - What food issues are particular to TB? - What are the livelihood strategies of households covering food needs in event of TB illness? - What is the role of power, gender, rural location and marginality in determining access and stress experienced by households facing these adversities? - What are the differences and similarities between Zambia and South Africa? 10 months anthropological fieldwork carried out in 20 households (10 TB patient, 10 non TB patient) in 2 ZAMSTAR sites in Zambia and Western Cape. None attached to this funding and study.
10. Study Design
11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if
None attached to this funding and study.
N/A
20
any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 15. Outcome measures
20 TB patient households (10 SA, 10 Zambia) 20 non-TB patient households (10 SA, 10 Zambia) Key adult informants in household = TB patients, Key woman, Head of Household. HIV status of TB patients will be known as part of wider ZAMSTAR study. Measures of community food flows recall and during fieldwork. At household level, anthropometric measurement of children & food stocks, sales & expenditure; health events & morbidity; labour; seek stocks; meals. Household indicators of environmental & structural resources, household structure, household resources, social resources & individual resources. Multi-dimensional typology of households cast according to high, middle, low capability of households to cope with TB as a stress additional to food insecurity & HIV/AIDS. Analysis will look at how households combine, utilise, exploit and allocate household resources (skills, work and material) in response to TB illness, HIV and food insecurity. Pemba/Batoka, Choma District, Southern Province, Zambia Mbekweni, Paarl District, Western Cape, SA NA August 2007 This is a qualitative study of small numbers which will allow a coping pattern to emerge on a qualitative scale from which we will develop a set of indicators that could be applied more rapidly and broadly by a wider set of disciplines and stakeholders.
21
No. 9
RENEWAL Regional 2
1. Your Name, Contact Information & Date
Bruce Frayne, PhD RENEWAL Regional Coordinator / Research Fellow International Food Policy Research Institute (IFPRI) PO Box 5689, ILRI Campus Addis Ababa, Ethiopia Tel: +251-(0)11-6463215 ext. 274 1 March 2006 Migration, HIV/AIDS and Urban Food Security in Southern and Eastern Africa International Development Research Centre (IDRC) Ottawa, Canada $384,000 RENEWAL International Food Policy Research Institute (IFPRI) PI Bruce Frayne Southern African Migration Project (SAMP) Southern African Research Centre (SARC) Queens University Kingston, K7L 3N6, Canada 3 years (2007-2009) The objective of this project is to better understand the interactions between migration, HIV/AIDS and food and nutrition security in Southern and Eastern Africa, with a focus on the urban-rural food supply and the food security of migrants in the city. The project situates itself at the nexus of migration, HIV/AIDS and urban food security, which interact in complex ways that are little researched and understood in the Southern and Eastern African context. While urban to rural remittances has been the predominant direction of commodity and cash transfers, benefiting the rural household economy, this dynamic is changing, with direct food transfers from rural households to urban households on the rise, as part of the migration process and urbanization process. However, while migration itself fuels the rapid spread of HIV in the region, the disease may be undermining this new social economy and urban food security through its impacts on rural production for the towns. In addition, HIV/AIDS may be diminishing the capacity of migrants to pursue other food security strategies in town too, including urban agriculture. The virus long wave epidemiology creates impacts in both the short and long terms, simultaneously changing the development context while creating intergenerational impacts that call for a next generation approach to the challenge of developing proactive, future oriented policy and programming. a) What is the contribution of rural food production at the household level for the food budget of urban households? b) To what extent is HIV/AIDS impacting both rural and urban household food security? c) How and to what degree are these impacts magnified or ameliorated by rural-urban migration and rural-urban linkages at the household level? d) What role does urban agriculture play in meeting the food gap of urban households, and is this influenced by HIV and AIDS?
2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study
22
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs
12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 15. Outcome measures 16. Location of Study 17. Published reports (website if available) 18. Expected date of final report/ publications 19. Additional Comments
e) Based on the research findings, what policy and programming interventions are required to address the development challenges posed by the triple threat of migration, HIV/AIDS and food insecurity? Project in planning phase, but will include households surveys This project will provide baseline information and analysis on the relationships between HIV/AIDS, the urban-rural food supply and the food security of migrants in the city. The findings will be communicated with national and city governments and recommendations developed for mainstreaming migration in food security and HIV/AIDS prevention and intervention programs. N/A
N/A
N/A
To be determined (project in planning phase) Southern and Eastern Africa (details to be determined project in planning phase) Not yet available 2009-2010 RENEWAL website: http://www.ifpri.org/renewal/index.htm
23
No. 10
Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Information & Date 2. Research Study Title Anne S.W. Mburu, ciirumb@hotmail.com, 3 March 2006 The Effects of Multimicronutrient Supplements And Food Rations On The Nutritional Status And Health Of HIVPositive Adults UNICEF courtesy of funding from the Dutch Government
*Anne S.W. Mburu (PI); David L. Mwaniki Centre for Public Health Research; Kenya Medical Research Institute, Nairobi, Kenya *formerly with CPHR-KEMRI Prof David I. Thurnham; University of Ulster at Coleraine, Northern Ireland, UK; UNICEF-ESARO 2002 -2003 The study undertook to investigate the effect of a daily multiple micronutrient supplement in combination with a daily food ration on the nutritional status, immunological status, epithelial integrity and general health of HIV positive adults. Prior to easier access to ARV, this study was undertaken to contribute to the limited but growing knowledge base on the impact of micronutrient and food ration interventions on the quality of life and general health and well being of adult HIVpositive men and non pregnant and non lactating women living in resource poor settings 1. What are the effects of a multimicronutrient supplement on the vitamin A, iron and zinc status of HIV positive adults. 2. What are the effects of a multimicronutrient supplement on the concentrations of CD4, CD8 subsets, selected plasma interleukins and selected acute phase proteins. 3. What are the effects of a multimicronutrient supplement on gut epithelial integrity. 4. Establish the effects of nutritional intervention on general health and well-being. Randomized double blinded and placebo controlled intervention with both arms receiving a food ration (90:10 precooked maize soy blend). Micronutrient provided between 1.3 and 2 X RDA of 16 vitamins and minerals. Participants took part for a duration of six months, within the first three months follow up was fortnightly, in the last three months follow up was monthly. Participants received a
10. Study Design
11. Describe intervention/ inputs such as counseling,
24
food/nutrient supplements frequency of inputs
supply of the daily Multiple micronutrient supplement or placebo capsules and precooked maize soy blend (UNIMIX 90% maize: 10% soy) to both arms of the intervention sufficient to cover the periods between follow up. Nutrition counseling was provided at each follow up. Confirmatory HIV tests were undertaken. Participants were provided with small notebooks and a pen to function as diaries so that they could ask the investigators questions and record their thoughts on the journey, a referral notebook was also provided for participants to procure treatment from the provincial general hospital when the need arose and for a copy of the prescribed medication to be recorded for the investigators reference. 180 individuals recruited, 177 participated at baseline (95 MMN and 82 placebo); at 3 months 95 participants (48 MMN and 47 placebo); at 6 months 48 participants (20MMN and 28 placebo) (note: MMN multimicronutrients) Criteria for eligibility: absence of active illness adult (18-45 years) male or non pregnant non lactating female tested for HIV and aware of status known local address willing to participate not taking any multivitamins or mineral preparations; not on ARVs, if diagnosed with Pulmonary Tb to have received a minimum of two months medication prior to participating on the study. Changes in nutritional status were assessed between baseline, 3 months and 6 months, these included changes in micronutrient status (plasma retinol and carotenoid status); haematological status, zinc, anthropometric status. Additionally, markers of inflammation were assessed these included changes in gut integrity; ESR, CRP, ACT, AGP and plasma cytokines. Immunological markers including total white blood cell counts; CD4, CD8 counts and their ratios were assessed. Changes in plasma viraemia were also assessed and finally a Lifestyle and QOL questionnaire was undertaken at Baseline and subsequently at 3 and 6 months in addition to food frequency questionnaires. Two towns in the Western Highlands of Kenya :Nakuru and Nanyuki 2003: ICASA NAIROBI - KENYA BMI Changes in Food Ration and Multimicronutrient supplemented HIV positive adults (poster): Mburu ASW, Mwaniki DL, de Wagt A, Thurnham DI, Selenje L.
14. Location of Study 15. Published reports (website if available)
25
Haematological response to Multiple Micronutrient and Food Ration Supplementation among adults living with HIV/AIDS (poster): Mburu ASW, Mwaniki DL, de Wagt A, Thurnham DI, Selenje L.
2004: AFRICAN HEALTH SCIENCES CONGRESS NAIROBI - KENYA Effects of Multimicronutrient Supplementation and Food Ration on Haemoglobin and Red Cell Morphology in HIV+ Adults (Poster): Mburu ASW, Mwaniki DL, Thurnham DI, Alumasa F, Muniu E, de Wagt A Changes in nutritional status, inflammation markers and symptom burden of HIV+ adults receiving a multiple micronutrient supplement and food ration (Oral): Mburu ASW, Mwaniki DL, Thurnham DI, Alumasa F, Muniu E, de Wagt A 2004: IVACG XXII PERU (Abstract T12) Effects of Multiple Micronutrient Supplements and a Food Ration Interventions Among Adult Men and Non Pregnant and Non Lactating Women Living With HIV/AIDS on Micronutrient Status (Poster): Mburu ASW, Mwaniki DL, Thurnham DI, Alumasa F, Muniu E, de Wagt A 2005: PROCEEDINGS OF THE NUTRITION SOCIETY Micronutrients in childhood and the influence of subclinical inflammation; Thurnham DI, Mburu ASW, Mwaniki DL, de Wagt A, (2005), Proceedings of the Nutrition Society, 64 (4): 502-509 2005: AFRICAN HEALTH SCIENCES CONGRESS EGYPT Field Experiences on a Nutrition Intervention Providing Multimicronutrient and Food Supplements to Adults Living With HIV/AIDS (Oral) Mburu ASW, Mwaniki DL, Thurnham DI, Alumasa F, Muniu E, de Wagt A 2006: BIOAVAILABILITY CHIANG MAI, THAILAND Using acute phase proteins to correct plasma ferritin concentrations enables ferritin to e used to show benefits of iron supplementation in apparently healthy adults living with HIV/AIDS (poster): David I Thurnham; Anne SW Mburu, David L Mwaniki, Fred Alumasa, Erastus Muniu, Arjan de Wagt. Subclinical inflammation may explain part of the high and low absorber phenomenon following supplements of
26
-carotene (oral): David I Thurnham; Anne SW Mburu, David L Mwaniki, Fred Alumasa, Erastus Muniu, Arjan de Wagt NB: name underlined indicates presenting author. Dissemination undertaken and Final report submitted to UNICEF; September 2004 Plasma acute phase protein concentrations to interpret nutritional status in people living with AIDS; David I. Thurnham; Anne S.W. Mburu; David L. Mwaniki; Erastus Muniu; Fred Alumasa; Arjan de Wagt (publication under review)
16. Expected date of final report/ publications
17. Additional Comments 18. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 19. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)?
Study approved by the Scientific Steering Committee and Ethical Review Board of KEMRI and the Contract Review Committee UNICEF. Intervention delivered through community based clinic, offering psychosocial support in addition to community education and interventions on cost effective methods of infection control. Participants visited clinic at recruitment and the intermittent follow up appointments assigned by the study investigators, but could visit between appointments if and when the need arose.
Pill counts were undertaken and recorded so as to monitor nutrition supplement compliance at each follow up visit. Register of food ration provided was maintained to monitor uptake and compliance as well as facilitate delivery mechanisms. Register and calendar kept of expected visits and any additional/unexpected visits noted.
27
No. 11
Operations Research on Food/Nutrition and HIV and AIDS
1. Your Name, Contact Information & Date Fathia Abdalla, Senior Nutritionist, UNHCR HQ, Geneva. Tel: + 41 22 739 8932 Fax: +41 22 739 73 66 Paul Spiegel (MD, MPH), Senior HIV Technical Officer UNHCR HQ, Geneva Tel +41 22 739 8289 Fax: 41 22 739 7371 Gebrewold Petros(Dr), UNHCR Liaison Officer to UNAIDS, UNHCR, Pretoria, South Africa. tel: +27 12 354 8315, fax: +27 12 354 8390 2. Research Study Title Implementation of program strategies to integrate HIV/AIDS and nutrition activities in refuge settings in Uganda and in Zambia. UNHCR, BPRM, UNICEF and WFP. Medium United Nations High Commissioner for Refugees (UNHCR) Projects are being implemented by implementing partners in both countries. UNHCR, UNICEF, WFP, The Governments of Uganda and of Zambia, and UNHCR Partners including GTZ, AAH, Zambia Red Cross Society 08 months as of September 2005 a. Implement different program strategies for integration of HIV/AIDS and nutrition activities in different refugee settings b. Evaluate and write lessons learned / better practice document / on how program strategies actually worked in real life situations. The rationale for the study is the recognition that humanitarian assistance presents many opportunities for interventions to reduce vulnerability to HIV/AIDS, as well as to mitigate the effects of the illness on health, nutrition and food security status of affected families. Refugee situations create opportunities for HIV/AIDS activities to be integrated into traditional food and nutrition programs. The United Nations High Commissioner for Refugees (UNHCR), the World Food Program (WFP) and the United Nations Childrens Fund (UNICEF), in collaboration with the respective governments of Uganda and of Zambia, has undertaken an initiative in 2003 and developed a program
3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study
28
manual, entitled Program Strategies for Integration of HIV/AIDS, Food and Nutrition Activities in Refugee Settings. What are best practices and lesson learned from implementation of the identified set of programming strategies for integrating HIV/AIDS, food and nutrition activities in refugee settings? 10. Study Design Prior assessment of the refugee settings, followed by selection of feasible strategies and implementation through an implementing partner (IP) in Uganda and through consultancy assistance and an IP in Zambia. The existing feeding programs, general food distribution mechanisms and the health care system are utilized. Demonstration gardens, training and IEC development take place locally. District health services and IPs working under health, community services and agriculture are involved. Coordination with partners and national officials, community mobilization activities, nutrition education and condom promotions are carried out. Monthly reports are shared at monitoring and coordination meetings, giving opportunity for discussion and immediate support. 12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) . 1.
Refugee populations where field testing occurs, especially women and children who are particularly vulnerable (direct beneficiaries).
2.
Local / host population where in integrated programmes, such as those in Uganda, benefit as well
Other refugee populations, UN agencies, NGOs and Governments (indirect beneficiaries)
3.
The total numbers of refugees in both countries who are benefiting from these projects are more than 57,174. Of these 28,729(50.2%) are females and 11,327 (20%) are children under the age of 5. The local / host population as well as other refugee populations, UN agencies, NGOs and Governments will be the indirect beneficiaries. 13. Outcome measures Performance as well as impact indicators are developed to monitor the courses and evaluate the impacts of the projects. Monthly reports and regular updates will be compiled and shared with all partners. Joint field monitoring missions are conducted at least twice to each of the project sites. Initial assessments, consultancy reports, monitoring reports and endproject evaluations will establish the success stories.
29
Kyaka II refugee settlement in Northern Uganda, Kala and Mwange refugee camps in Northern Zambia Not yet; however, monthly reports and progress updates are available. No web site is available yet. Second quarter of 2006
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30
No. 12
Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Dr. Robert Kabumbuli, Department of Sociology, Information & Date Makerere University, P. O. Box 7062 Kampala, Uganda. 6th March 2006 2. Research Study Title Land ownership and food security in Uganda: A
Study of the use and control of land among household of women affected by HIV/AIDS in four districts
3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives IFPRI - $42,000
Makerere University, Department of Sociology Dr. Robert Kabumbuli
National Council of Women Living With HIV/AIDS One Year
Establish the relationship between HIV/AIDS and property ownership/control, and food security. In order to bring about an increase in the responsiveness of local, national intervention programmes to the problem of land insecurity/loss among women affected by HIV/AIDS. Local communities will be galvanised to formulate local interventions to safeguard their interests in family property because they are often unable to access or afford national level interventions. How does the onset of ill health and death (of the male spouse) influence the ownership/control and use of family property especially land? What are the intervening factors/variables in the change of land ownership when a household is experiencing HIV/AIDS? What interventions are in place to address the problem of property loss, and what improvements can be made to these interventions?
Focus group discussions and key informant interviews with local communities, leaders and staff of local organisations, and policy makers. A household questionnaire will provide quantitative indicators. Communities will be helped to formulate locally appropriate interventions to address the problem of land loss among women affected by HIV/AIDS. Interventions will be developed in a participatory
10. Study Design
11. Describe intervention/ inputs such as counseling, food/nutrient
31
supplements frequency of inputs 12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
way from the data of the study. Interventions formulated in the study will be implemented by communities on a self-help basis, but will seek legitimation from the local government by involving the local officials in the study.
----
600 respondents for the quantitative assessment. Of these, half will be a control group. Sample will be drawn from four districts in equal proportions. Main study sample will be women with HIV/AIDS and belong to farming household, or have lost a spouse and belong to farming households. The control sample will be of women in farming households not known to be affected by HIV/AIDS. The qualitative sample will include local leaders and opinion leaders, staff of NGOs and CBOs, legal experts, policy makers. Data will be gathered on socio-economic, demographic characteristics of households. Data will also be gathered on the influence of variables such as tenure systems, inheritance systems, etc. Land use characteristics will also be documented and related to the independent variables. Qualitative and quantitative indicators will be used to help communities formulate viable interventions to prevent loss of property among women households affected by HIV/AIDS as a measure for food security. Four districts of the country; one district representing each of the four regions of the country. Mbarara district in the western region, Luwero district in central region, Tororo district in eastern region, and Lira district in northern region. Three sub-counties have been selected in each district.
16. Location of Study
32
At least two publications expected out of this study Final study report will be in March 2007
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33
No. 13
Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Susan Thurstans, Action Against Hunger Malawi, tel: Information & Date +2659960499, email: hivnut@aahmw.org (Nuria Salse responded) 2. Research Study Title A pilot programme to assess the impact of treating acute
malnutrition on mortality in adults and adolescents starting ARV therapy in Malawi

3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives UN consortium: WFP, Unicef, WHO, FAO, UNAIDS 46,000 USD Action Against Hunger Susan Thurstans
Malawi Ministry of Health 1 year May 2004 April 2006 1. To provide supplementary feeding to all malnourished new ART patients in six pilot centres 2. To provide knowledge and skills to people living with HIV taking ART and their caregivers or guardians for effective nutrition management of infections, conditions and drug side effects 3. To compare the response of people taking ART receiving nutritional support with CSB mixed with oil and no nutritional support (in the future this result will be compared with the one of ART clinics distributing plumpy nut). 4. To monitor the effectiveness of providing therapeutic and supplementary foods to existing patients taking antiretroviral therapy, and its impact on morbidity, mortality and adherence
The scale up of ART in Malawi is well under way. Currently 59 centres are providing ART. The cumulative number of people that have been started on ART is 17,601 up to March 2005. Of these 81% are alive and on ART, 8% have died, 7% have defaulted or are lost to follow up, <1% have stopped treatment, and 2% have transferred out of the programme to another centre (MOH HIV unit July 2005). With the implementation of highly active antiretroviral therapy (HAART) to Malawi, it is important to consider the nutritional implications for people taking HAART. From the 8% who died 75%
34
of these patients died in the first three months of initiating therapy. It is unknown whether this is due to poor nutritional status, or opportunistic infections that are difficult to diagnose such as disseminated TB. It is known that malnutrition is highly prevalent amongst HIV infected adults and children. There is therefore, a need to assess the impact of nutritional treatment and support to people living with HIV on morbidity and mortality. Currently in Malawi therapeutic and supplementary feeding is targeted largely at children. In March 2004 the Ministry of Health, UNICEF, UNAIDS, WFP, WHO and FAO, formed a working group on HIV and nutrition. Action Against Hunger was also invited to take part in this group. Terms of reference were written for a consultancy on the need for nutritional support to people taking ART. The main findings from this consultancy and the working group were the need for a structured approach to a nutrition component consisting of nutrition counselling, treatment for acute malnutrition, and food security and income generating activity interventions for patients on ART.
At the same time, a decision was made by the Ministry of Health to purchase F75, F100, and plumpy nut therapeutic feeds for acutely malnourished adults taking ART, using the ART clinics as a point of entry. The ministry of health Malawi has plans to integrate nutrition interventions into the national scale up of ART. Nutrition interventions will be based largely on the stage of infection. For those people who are symptomatic, interventions will focus on nutritional counselling, and therapeutic and supplementary feeding for those who fit into the criteria set by the ministry of health. Therapeutic and supplementary feeding before and during initiation of ART may help to improve a patients tolerance and adherence to HAART, and improve nutritional status. What is the impact of providing therapeutic and supplementary feeding to acutely malnourished HIV positive patients, on morbidity, mortality and quality of life, and what are the appropriate indicators in Malawi Pilot intervention All patients staring ARV therapy will be assessed anthropometrically by a health surveillance assistant. Those reaching the criteria for severe malnutrition will be treated
10. Study Design 11. Describe intervention/ inputs such as counseling,
35
food/nutrient supplements frequency of inputs
12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 13. Outcome measures
with 520g of RUTF per day. Those reaching the criteria for moderate malnutrition will receive 9kgs of CSB and 1 litre of oil per month. All patients including those who are not malnourished will receive nutrition counselling. Patients are followed up at baseline, 2 weeks, and then monthly. An estimated 450 patients will be recruited onto the pilot programme. Patients should be HIV positive and newly starting ARV therapy, with a BMI <17 or a W/H <80% if under 18. 1. Measurable indicators include: a. Anthropometrical measures b. Mortality c. Clinical condition including CD4 counts where available d. Adherence rate in people taking ART e. Ambulatory status f. Ability to go to work or school g. Number of people on ARVs with knowledge of recommended dietary practices recommended for people living with HIV. h. Number of people who practice recommended dietary practices for people living with HIV, and those taking antiretroviral therapy 2. Final report on monitoring with recommendations for future activities related to nutritional support 6 ARV sites in Malawi, Northern region: Chitipa, Rumphi; Central region: Dowa; Southern region: Zomba, St Lukes, Chikwawa N/A End of May 2006
This intervention was a pilot programme not a study
36
No. 14
Compilation of Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Valid International: Steve Collins and Paluku Bahwere paluku@validinternational.org Information & Date steve_s at@validinternational.org March 2006 2. Research Study Title Acceptability and effectiveness of nutrition support with a Chickpea-Sesame based Ready-to-Use-Therapeutic Food (CS-RUTF) in chronically sick adults delivered through a home based care (HBC) programme. 3. Optional Valid International Funding source(s) and level of funding 4. Name of Valid International, Organization and Steve Collins, Paluku Bahwere Principal Investigator(s) 5. Partners in study Nkotakhota AIDS Support Organisation (NASO) and Salima AIDS Support Organisation (SASO), Concern Worldwide 6. Duration/Timeline Started in May 2005 and completed in November 2005, publication expected in 2006 7. Objectives 1. Assess the capacity of HBC organizations in Malawi
to include provision of CS-RUTF to malnourished symptomatic HIV positive adults in their activities. 2. To assess the acceptability and impact of CS-RUTF on activity performance, nutritional status and HIV services uptake for malnourished HIV adults prior to commencing or at the time of commencing antiretroviral therapy (ART) in Malawi. 1. In Malawi, mostly in remote areas, HIV is suspected when the patient is already very sick and wasted. These patients are not currently eligible for ART because of their poor status as the ART clinics require the eligible patient to be ambulatory and to be stabilized prior to starting ART. 2. Currently in Malawi hospitals do not have the capacity to provide inpatient care to all those in need of stabilization prior to commencing ART. 3. CTC offers several important opportunities to integrate nutrition support with HBC and to support wider home-based initiatives to address malnutrition associated with HIV/AIDS. In order to strengthen the evidence base of the effectiveness of home-based nutrition management and the impact of appropriate food supplementation on the nutritional and clinical status of HIV-infected individuals and to monitor the impact on coverage and uptake of HIV services.
37
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
1. Acceptability of CS-RUTF 2. Capacity of HBC to deliver home-based nutrition support using RUTF 3. Benefits of the intervention on health, nutrition and quality of life (activity performance) of HIV-infected individuals. Observational Non randomized All patients received CS-RUTF (500 g/day), cotrimoxazole, VCT and nutrition counseling.
Total 56 patients. Eligible patients were clients of the participating AIDS support organization who were chronically ill, adults (above 18 years) and had BMI<17 or MUAC<210 cm or bilateral pitting edema. All the patients were not tested at inclusion but the HIV status was confirmed during the follow up. Continuity of CS-RUTF supply to patients, adherence to the programme, CS-RUTF intake, weight gain, MUAC gain and BMI change, Karnofsky score change and HIV services uptake. Mortality was not among the primary outcomes of interest but will also be described. Communities from the catchments area of NASO in Nkotakhota and SASO in Salima, Malawi. NA June 2006
N/A
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No. 15
Compilation of Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Information & Date 2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives Valid International kate@validinternational.org steve_sat@validinternational.org March 2006 Integrating HIV services into a Community Therapeutic Care (CTC) programme in Malawi: an operational research study Bureau for Africa, Office of Sustainable Development of the United States Agency for International Development (USAID) and Food and Nutrition Technical Assistance (FANTA) Valid International: Corresponding author: Steve Collins
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient
Paluku Bahwere, Marthias Chimeteleni Joshua, Kate Sadler, Caroline Grobler-Tanner, Ellen Piwoz, Saul Guerrero To start April 2006 for one year To assess the uptake of HIV testing and the impact of a Community Therapeutic Care (CTC) programme on the rehabilitation of severe acute malnutrition (SAM) in HIVinfected children. Previous research in Malawi, as well as in other areas where HIV is highly prevalent, indicates that 30% or more of children admitted to Nutrition Rehabilitation Units (NRU) are HIV-positive. Studies have shown that severely malnourished HIV-infected children can achieve an adequate weight for height, although recovery times are significantly longer and mortality is much higher compared to HIVuninfected children. However, the majority of HIV-positive children in Africa never receive any nutritional care either because their status is not known or because their care-givers (often HIV infected themselves) are unable to bring them to hospital or remain with them for extended periods. To assess the feasibility of treating severely malnourished HIV-positive children in the community rather than in inpatient NRUs. 1. Can CTC be used as an entry point for providing HIV testing and treatment referral. 2. Are the CTC protocols effective in rehabilitating HIVpositive children. 3. Can proxy indicators be identified for paediatric HIV that could be used in communities where diagnostic testing is not available. A prospective and retrospective community-based cohort study Voluntary HIV testing and counseling for caregivers and children offered, and basic medical care, including antibiotics for bacterial infections, de-worming, vitamin A supplementation, malaria prophylaxis and treatment, anaemia
39
supplements frequency of inputs 12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
13. Outcome measures 14. Location of Study 15. Published reports (website if available) 16. Expected date of final report/ publications 17. Additional Comments
treatment, and Ready-to-use Therapeutic Foods (RUTF) for community-based nutrition rehabilitation Children 0-59 months with severe acute malnutrition (SAM): indicated by weight-for-height (WFH) <70% of the NCHS reference median and/or bilateral pitting oedema and/or midupper arm circumference (MUAC) <110 mm. Two groups of caregivers were invited to participate: 1) those who were discharged from CTC prior to VCT introduction (retrospective cohort): 1273 eligible 2) those who entered CTC after testing was introduced (prospective cohort): 735 eligible Uptake of HIV testing, recovery, relapse, and growth rates of HIV-positive and uninfected children in the CTC programme Dowa District, Central Malawi, a rural area 50 km from the capital, Lilongwe NA Submitted for publication
Results: Overall uptake of HIV testing was 60.7% for adults and 94% for children. HIV prevalence in severely malnourished children was ~ 3%. 59% of HIV-positive and 83% of HIV-negative children achieved discharge percentage of median weight for height (WFH) > 85% (p=0.003). Clinical algorithms for diagnosing HIV in SAM children had poor sensitivity and specificity. CTC is a potentially valuable entry point for providing HIV testing and care in the community. ART should be reserved for children who do not respond nutritionally to CTC
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No. 16
Compilation of Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Valid International kate@validinternational.org Information & Date steve_sat@validinternational.org March 2006 2. Research Study Title Moyo RUTF Study: A randomised controlled trial to compare the efficacy of three new formulations of Ready-to-Use Therapeutic Food (RUTF) in the treatment of severe acute childhood malnutrition (HIV positive and HIV negative children) 3. Optional Valid International Funding source(s) and level of funding 4. Name of Valid International: Marko Kerac, Steve Collins, Organization and Principal Investigator(s) 5. Partners in study Kate Sadler, James Bunn, Prof Joseph Mufutso Bengo, Andrew Seal, Prof Andrew Tomkins - Institute of International Child Health, UK - College of Medicine, Blantyre, Malawi 6. Duration/Timeline To start April 2006 for one year 7. Objectives To investigate the efficacy of three new RUTFs in the treatment of SAM in both HIV +ve and ve children admitted to Moyo Therapeutic Feeding Centre (TFC) at Queen Elizabeth Central Hospital, Blantyre, Malawi. 8. Rationale for study Ready-to-Use Therapeutic Foods (RUTF) are a key technology which facilitate the outpatient treatment of severe acute malnutrition (SAM). They have been central to the development of Community-based Therapeutic Care (CTC), a public health approach to SAM which is rapidly gaining popularity internationally. The high cost of the Plumpynut, the reliance on one type of RUTF alone, and the dangers of Aflatoxin contamination from groundnuts are important barriers to the success and wide uptake of CTC. To be effective, CTC programmes require appropriately formulated, cheap and readily available sources of RUTF. 9. Study question(s) 1. To compare the clinical and nutritional efficacy of a new formulation, low-milk/chickpea-based RUTF against the currently used, high-milk/peanut-based locally made Plumpynut in the treatment of SAM 2. To compare the clinical and nutritional efficacy, of Synbiotic-enhanced RUTF with standard RUTF during the treatment of SAM (HIV +ve and ve children). 10. Study Design Randomised controlled study 11. Describe Children enrolled in the study will be randomly allocated to : intervention/ inputs 1. Group 1 :(Control group) - Locally made highsuch as counseling, milk/peanut-based Plumpynut RUTF food/nutrient 2. Group 2: New low-milk/chickpea-based RUTF
41
supplements frequency of inputs
3. Group 3: High-milk/peanut RUTF mixed with Synbiotic forte 2000. 4. Group 4: Low-milk/chickpea-based RUTF mixed with Synbiotic forte 2000. Fortnightly outpatient review of clinical progress and anthropometry and further supplies of RUTF given. Initial pilot study of 30 children to assess acceptability and side effects, followed by 1200 SAM children: 300 assigned to each group Recruited from Moyo House Malnutrition Unit phase 2 rehabilitation phase once appetite is returning, oedema reducing to at least ++ or below and the child is clinically stable and requires no further inpatient care Number cured (weight gain to 80% weight for height); mortality, rate of weight gain, number of days with diarrhea, length of stay, default rate, number of excess illness episodes, body composition (skinfold caliper measures), tolerance to RUTF Moyo House Therapeutic Feeding Centre (TFC) at Queen Elizabeth Central Hospital, Blantyre, Malawi NA Results will be presented at nutrition and medical meetings in Malawi and in other countries and published in an appropriate medical publication Results: after April 2007 N/A
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No. 17
1. Your Name, Contact Information & Date 2. Research Study Title 3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study 6. Duration/Timeline 7. Objectives Operations Research on Food/Nutrition and HIV and AIDS Paul Bukuluki E-mail: pbukuluki@ss.mak.ac.ug Gender dimensions in food/nutrition security and HIV/AIDS in Internally displaced peoples camps in Uganda RENEWAL/FORD Foundation
Makerere University, Faculty of Social Sciences Paul Bukuluki Stella Neema Save the ChildrenUganda, Uganda Red Cross Society One year and a half
To find out womens understanding and experience of food insecurity and the risks that result from coping with the problem in IDP camp settings; To examine the impact of armed conflict and displacement on peoples perception of the risk of HIV infection and the influence of this perception on behavioural responses to HIV/AIDS interventions; To assess the gender responsiveness of existing HIV/AIDS and food security strategies/policies in addressing HIV/AIDS and nutrition needs of IDPs; To identify and analyze the strengths and resources that exist at the individual, household, community and institutional level that help to minimize vulnerability to food insecurity and associated risks of HIV infection especially among women and girls in IDPs; To use the findings and experiences of this action research process to enhance policy dialogue, advocacy and programming in respect to food/nutrition insecurity and HIV/AIDS in situations of armed conflict and displacement
Gender issues; access to resources, control over resources (food, money, skills, information, basic services etc.), gender roles, power relations between females and males on one hand, and between females and power lines/authority structures in IDP camps (camp commandants, guards, food controllers, government and rebel military structures) on the other could constitute central features in the interactions between HIV/AIDS and food insecurity. We do not have a clear and precise understanding of the interactions between gender issues and HIV/AIDS, food poverty and nutrition insecurity operating in the context of armed conflict situations (in IDPs). We do not know the socio-cultural, gender and structural factors in the context of armed conflict in IDP camps that make girls/women vulnerable to sexual exploitation and how this is linked to the issues of food poverty.
43
How do IDPs cope (negative and positive coping mechanisms) with the different manifestations of food insecurity and high prevalence of HIV/AIDS/STI? What strengths, initiatives and resources exist at the individual, household, community and institutional level that help to minimize vulnerability to food insecurity and HIV infection among IDPs? What gender related policy and programming gaps exist in current policies and interventions on food security and HIV/AIDS in conflict affected areas (especially IDP camps) that need to be targeted for change?
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Describe intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)? 13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, Distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 15. Outcome measures 16. Location of Study
Descriptive and exploratory We will use the findings to develop an advocacy strategy and to provide evidence for policy dialogue and programming
We are going to work with community groups, implementing NGOs and standing committees on HIV, food and nutrition in the Uganda Parliament
Yet to start data collection
300, young women and men living in IDP camps in the selected districts
Uganda (Gulu and Katakwi districts)
44
Not yet January/February 2007
We are at the phase of contracting. Study operationalisation begins in mid march 2006
45
No. 18
Compilation of Operations Research on Food/Nutrition and HIV and AIDS SCN Nutrition and HIV/AIDS Working Group 1. Your Name, Contact Information & Date 2. Research Study Title Anne Strauss, World Food Programme , Anne.Strauss@wfp.org, Susanne Carai, WFP, Susanne.Carai@wfp.org 02.03.06 INIPSA* A Nutrition Intervention within a comprehensive ART care package with an Impact Evaluation *Impact du Soutien Nutritionnel Integre a la Prise en charge
Globale des Patients Sous ARV
Anne Strauss, World Food Programme , Anne.Strauss@wfp.org
10. Study Design 11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.) 13. Outcome measures
WFP, FAO, WHO, ILO, DIAL-IRD, IMEA, Institut de Medicine Tropicale DAntwerp, INSERM U687 January 2005-January 2008 Compare the impacts of the INISPA nutrition intervention as part of a global care package on patients under ART in Benin, Burundi e Mali with a comparison group receiving different packages. WFP is working with partners to strengthen the evidence base of the impacts of nutrition interventions on the clinical, socio-economic and activity status of patients under ART. What are the clinical and socio-economic impacts of nutrition interventions as part of global care package on patients under ART and what are the impacts on their activity? Randomisation by treatment centers The INIPSA sample will receive nutritional education and counseling, food assistance as part of the global care package for those in need (limited duration) combined with income generating activities. 350 sample and 350 control group for each country, Eligible people will be enrolled in ART treatment in the treatment centers, over 15 years of age and nonpregnant. Clinical status (medical indicators), opportunistic infection (type and frequency), nutritional status (weight, BMI, dietary intake and patterns), physical and psychological ability to work, availability to
46
work (ILO definition), employment, income generation and assets , quality of life ART treatment sites in Mali, Benin and Burundi N/A End 2008
47
No. 19
KEMRI Kenya RUTF and HIV Study Operations Research on Food/Nutrition and HIV and AIDS 1. Your Name, Contact Information & Date 2. Research Study Title Bruce Cogill, FANTA Project/AED; bcogill@aed.org 8 March, 2006 Randomized controlled evaluation of the impact of food supplements on malnourished HIV-infected adult ART clients and malnourished, HIV-infected pre-ART adults in Kenya. USAID (PEPFAR) FANTA Project/AED
3. Optional Funding source(s) and level of funding 4. Name of Organization and Principal Investigator(s) 5. Partners in study
Principle Investigators: David Mwaniki, Robert Mwadime Co-Investigators: James Muttunga, Erastus Muniu, Tony Castleman, Bruce Cogill FANTA Project/AED, Institutional Affiliation: Kenya Medical Research Institute (KEMRI) Food and Nutrition Technical Assistance (FANTA) Project, Academy for Educational Development
Start Feb 2006 with study completed in January 2007 and final report in October 2007 Asess the impact of food supplementation on nutritional and clinical status, treatment progress, and quality of life of malnourished adult ART clients and malnourished HIVinfected adults who are pre-ART. Specific objectives are to: 1) Compare feeding on nutritional and clinical outcomes, adherence and general quality of life of malnourished (BMI<18.5) HIV-infected adults initiating ART. 2) Compare the relative impact of nutrition counseling alone versus nutrition counseling and supplementary feeding on the nutritional and clinical outcomes, and general quality of life of malnourished (BMI<18.5) HIV-infected adults who are symptomatic but do not meet ART eligibility criteria (pre-ART) and who are beginning or have begun taking cotrimoxazole prophylaxis within the past four months.
In order to strengthen the evidence base about the impacts of food supplementation on the nutritional and clinical status of
48
HIV-infected individuals, FANTA is working with local partners to conduct a targeted evaluation of specific therapeutic food on adult subjects taking ARVs. An assumption underlying the study question is that oral supplementation is an effective means to increase net daily macronutrient and micronutrient intake of malnourished HIVinfected individuals. Whether food supplementation of nutritionally compromised HIV-infected people (pre-ART and ART) in resource constrained settings improves their nutritional status, clinical status, effectiveness of treatment, and quality of life/functioning, and survival? Two basic groups of clients will be evaluated. Arm A: Adult HIV-infected individuals with BMI < 18.5 who will begin ART within 5 weeks (total 600). Subjects from this group will be randomly assigned to receive one of two interventions (300 in each sub-group): Group AI: nutrition counseling alone for 12 months Group AII: 300 g/d of Foundation Plus/Insta Flour for 6 months; and nutrition counseling for 12 months. Arm B: Adult HIV-infected individuals with BMI < 18.5 who do not qualify for ART who have CD4 between 200-500 and who are beginning or began cotrimoxazole within the past four months (total 600). Subjects from this group will be randomly assigned to receive one of two interventions (300 in each sub-group): Group BI: months Group BII: 300 g/d of Foundation Plus/Insta Flour for 6 months; and nutrition counseling for 12 months Subjects from the pre-ART group who meet the conditions for ART during the study period will be provided ART and will continue to receive food for the same duration as other subjects in the pre-ART group. Data on these subjects from the period after they begin ART will not be included in the analysis. nutrition counseling alone for 12
10. Study Design
11. Describe intervention/ inputs such as counseling, food/nutrient supplements frequency of inputs 12. Describe
See 12
FANTA/AED and the Kenya Medical Research
49
intervention delivery mechanisms used in the study. That is, how was the intervention delivered (e.g., at home, by community groups, as part of antenatal care, through mobile clinics, at Immunization clinics, with growth monitoring)?
Institute (KEMRI) will work with Insta Products Ltd. to conduct this operations research. Two types of subjects will be recruited from comprehensive care clinics (CCC) for the evaluation: HIV-infected adults with low BMI who are enrolled to begin administration of ART within five weeks; and HIVinfected adults with low BMI who do not yet qualify for ART but are receiving cotrimoxazole as a prophylactic for opportunistic infections. Given the low number of eligible subjects at any single site, the study will be conducted in four sites: i) Kenyatta National Hospital, ii) Machakos District Hospital, iii) Maragwa Sub-district Hospital, and iv) AMURT-ARV treatment center in Kangemi, Nairobi.
Food supplements The food supplement to be used in this study is produced by Insta Foods Kenya Ltd, based at the Export Processing Zone (EPZ) in Athi River, Kenya. The product is Insta Foundation Plus with whey protein concentrate added; it is a blend of maize, soya, vegetable oil, sugar, whey protein concentrate, and micronutient pre-mix. The nutrient content of the supplement is shown in the table below and has been confirmed by SGC International. Insta Foundation Plus is a ready-to-use, pre-cooked food. However, the food needs to be hydrated using boiled hot water or milk. The food will come in 3 packets of 100g each, or total of 300g (1,320 Kcal/day and approx. 1 DRI for a HIV+ adult), the targeted amount for one day. Each patient will be provided a months supply, which is 10kg (300g/d x 30 days = 9,000g + an additional buffer supply for three days). The food will be labeled with instructions on how to use it and the nutrient content, and there will be space on the label for the name of the client and the date for the next visit to collect food. Each client will be instructed on how to use the food and given strict instructions not to share the food with others in or out of the household. The food supplements will be distributed monthly at the nutrition centres within the study sites where nutritional counselling will be provided to all referred clients. Follow-up assessment of adherence and the use of the food will be conducted during clients monthly visits to the treatment centre. Food supplements will be provided for six months or until subjects reach the agreed exit criterion of BMI = 23, whichever comes first.
50
13. What process data, if any, were gathered on how well the delivery worked (e.g., coverage, attendance, operational feasibility, distribution)? 14. Estimated number of subjects, eligibility criteria and description (age, HIV status, etc.)
Data include a history of current clinical symptoms (fever, cough, vomiting, appetite and diarrhea) and their duration will be elicited, as well as any medications or other medical diagnoses. Questions to determine the compliance with the ART will be asked, as well as pill counts made, once subjects have started ART. Dietary intake assessments total 1,200 Eligible subjects will be adults (> 18 years old) diagnosed with AIDS and scheduled to begin treatment with ART within 5 weeks with a body mass index (BMI) of < 18.5. All women who say that they are pregnant or lactating will be excluded. Subjects will be recruited from individuals attending study four treatment sites: i) Kenyatta National Hospital, ii) Machakos District Hospital, iii) Maragwa Subdistrict Hospital, and iv) AMURT-ARV treatment center in Kangemi, Nairobi Basic socio-demographic data will be collected; such as birth date, age, sex, address, occupation, and measures of economic status. A quality of life assessment will be administered. Data on subjects nutritional status (BMI, BIA, and serum albumin), clinical status (HIV disease progression, viral load, CD4/8 count, C-Reactive Proteins, clinical events hospitalizations, deaths and non-severe clinical events), quality of life, and adherence to ART and Contrimoxazole will be collected/ Four treatment sites: i) Kenyatta National Hospital, ii) Machakos District Hospital, iii) Maragwa Sub-district Hospital, and iv) AMURT-ARV treatment center in Kangemi, Nairobi N/A
17. Published reports (website if available)
October 2007 with publication in mid-2008
Institutional Review Board approval in US and Kenya completed.
51

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Collation of Nutrition and HIV Studies for the Standing Committee for Nutrition, Geneva Food and Nutrition

17. 18. 19.

5. Partners in study 6. Duration/Timeline 7. Objectives

8. Rationale for study

13. Outcome measures

8. Rationale for study

15. Outcome measures

16. Location of Study 17. Published reports (website if available)

18. Expected date of final report/ publications 19. Additional Comments

December 2007 with publication in mid-2008

Institutional Review Board approval in US and Malawi completed.

8. Rationale for study

14. Location of Study 15. Published reports

8. Rationale for study

10. Study Design

15. Outcome measures

8. Rationale for study

10. Study Design

8. Rationale for study

10. Study Design

2. Research Study Title

8. Rationale for study

10. Study Design

17. Published reports (website if available)

18. Expected date of final report/ publications 19. Additional Comments

8. Rationale for study

10. Study Design

None attached to this funding and study.

1. Your Name, Contact Information & Date

8. Rationale for study

8. Rationale for study

10. Study Design

11. Describe intervention/ inputs such as counseling,

food/nutrient supplements frequency of inputs

13. Outcome measures

14. Location of Study 15. Published reports (website if available)

16. Expected date of final report/ publications

8. Rationale for study

Makerere University, Department of Sociology Dr. Robert Kabumbuli

National Council of Women Living With HIV/AIDS One Year

8. Rationale for study

10. Study Design

11. Describe intervention/ inputs such as counseling, food/nutrient

15. Outcome measures

16. Location of Study

malnutrition on mortality in adults and adolescents starting ARV therapy in Malawi

8. Rationale for study

10. Study Design 11. Describe intervention/ inputs such as counseling,

food/nutrient supplements frequency of inputs

14. Location of Study

This intervention was a pilot programme not a study

8. Rationale for study

13. Outcome measures

8. Rationale for study

supplements frequency of inputs

13. Outcome measures

8. Rationale for study

Yet to start data collection

Uganda (Gulu and Katakwi districts)

Not yet January/February 2007

Anne Strauss, World Food Programme , Anne.Strauss@wfp.org

8. Rationale for study

8. Rationale for study

10. Study Design