Professional Documents
Culture Documents
April 2015
!
Table&of&Contents&
Acknowledgements...................................................................................................................2!
Introduction................................................................................................................................3!
Multidisciplinary.Team.Composition.and.Roles.............................................................4!
Viral.Load.Algorithm................................................................................................................6!
Clinical.Summary.Form...........................................................................................................8!
Adherence.and.Retention.Assessment.and.Support..................................................10!
Introduction.......................................................................................................................................10!
Objectives............................................................................................................................................11!
Case.Manager.....................................................................................................................................11!
Adherence.assessment.and.enhanced.adherence.counselling.........................................11!
Morisky!Medication!Adherence!Scales:!MMAS 8!........................................................................!13!
Adherence!sessions!in!details!.................................................................................................................!15!
Mental!Health!Screening!...........................................................................................................................!18!
Enhanced.Adherence.Counseling.Sessions.Documentation..............................................20!
Adherence.Counseling.for.Adolescents....................................................................................21!
3rd.line.ART.client.education.and.counselling.sessions......................................................23!
Key!Messages!on!Treatment!Failure!and!Use!of!Viral!Load!.......................................................!23!
Adherence.support.systems.........................................................................................................24!
Patient.Management.Protocol............................................................................................29!
Clinical.Encounter.Form.......................................................................................................31!
Commodity.Management.Standard.Operating.Procedures.....................................32!
Requesting.for.Third.Line.Medicines.for.New.Patients.......................................................32!
Documenting.the.Dispensing.of.Third.Line.Medicines........................................................33!
Reporting.Consumption.and.Resupply.Requests.for.Patients.on.Third.Line.
Treatment...........................................................................................................................................35!
Third.Line.ARV.Drug.Information....................................................................................41!
RALTEGRAVIR.(Integrase.Inhibitor).........................................................................................41!
DARUNAVIR.(WITH.RITONAVIR)YProtease.Inhibitors........................................................43!
ETRAVIRINE.(NonYNucleoside.Reverse.Transcriptase.Inhibitor)...................................45!
Medication.Use.Counseling.(MUC)....................................................................................47!
Pharmacovigilance.................................................................................................................48!
Quarterly.Reporting.Tool....................................................................................................49!
List.of.Contributors................................................................................................................50!
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1!
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Acknowledgements&
.
The! development! of! the! Toolkit! for! 3rd! Line! Antiretroviral! Therapy! is! a! result! of!
various! efforts! by! the! 3rd! Line! ART! working! group,! drawn! from! different!
organizations!and!coordinated!by!NASCOP.!The!package!was!developed!to!build!the!
capacity!of!healthcare!workers!at!facilities!providing!3rd!line!ART!for!patients.!
!
Special!and!sincere!appreciation!goes!to!the!NASCOP!Care!and!Treatment!team!for!
spearheading!this!process!and!working!tirelessly!to!develop!this!tool!kit,!under!the!
leadership!and!coordination!of!the!ART!Program!Manager.!
!
Special! and! sincere! appreciation! also! goes! to! our! partners,! NGOs,! technical!
organizations,!individuals!and!all!members!who!participated!in!many!meetings!and!
workshops!to!share!useful!ideas!towards!the!development!of!this!document.!!
.
.
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2!
!
Introduction&
.
As!of!January!2015,!Kenya!had!763,859!patients!on!ART!of!whom!697,647!are!adults!
and!66,212!are!children.!There!are!32,579!on!second!line!regimens!and!21!patients!
who! will! immediately! access! 3rd! line! ART! through! the! national! program.! However!
we!are!in!the!process!of!strengthening!systems!to!identify!additional!patients!who!
qualify!for!3rd!line!ART.!
!
Kenya! has! recently! obtained! the! third! line! ARV! medications! for! patients! and!
developed!a!tool!kit!to!provide!guidance!to!health!care!workers!and!health!facilities!
in!order!to!provide!3rd!line!ART.!
!
This!tool!kit!provides!guidance!on!diagnosis!of!second!line!treatment!failure,!patient!
preparation! for! treatment! and! adherence! support! for! 3rd! line! ART,! medication!
information,!commodity!management!and!reporting.!
!
We! recognize! that! there! are! limited! treatment! options! for! patients! beyond! the! 3rd!
line! regimen! and! as! such! recommend! that! health! care! workers! and! patients! work!
together!and!strengthen!systems!to!preserve!this!regimen.!
!
We!anticipate!that!this!tool!kit!will!be!useful!to!you!as!clinicians!and!welcome!your!
feedback!on!it!at!ulizanascop@gmail.com.!
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3!
!
Multidisciplinary&Team&Composition&and&Roles&
.
Every&facility&providing&3rd&Line&ART&should&have&a&Multidisciplinary&Team&(MDT)&whose&
role&is&to&ensure&that&the&patient&receives&the&highest&quality&of&care&available&through&a&
team&approach&to&care&and&in&applying&quality&improvement&initiatives.&
Members&of&the&MDT&
• Clinical&care&provider&(medical&officer&and/or&clinical&officer/consultants)&
• Pharmacy&
• Adherence&counselor&&
• Nutritionist&&
• Laboratory&personnel&
• Social&worker&
• Health&Records&Officer&&&
• Case&manager&
Objectives&of&the&MDT&
• To&improve&the&capacity&and&skills&of&HCW&to&offer&quality&health&services&and&
strengthen&the&health&systems&at&facility&level&
• Improve&treatment&standards&and&decision&making&
• Identify&gaps&in&service&provided&and&plan&how&to&address&those&identified&needs&
&
Running&an&MDT&Meeting&&
• Appoint&a&chair&and&secretary&for&each&meeting&
• Review&the&agenda&(see&example&of&standing&agenda)&
• Conduct&meeting&&
• Summary&of&action&items,&persons&responsible,&timelines&and&follow&up&plan&
• Date&of&next&meeting&(recommend&weekly)&&
&
Suggested&Standing&Agenda&
• Review&of&previous&minutes&and&matters&arising&&
• Care&and&Treatment:&&
o Review&the&care&and&ART&history&of&the&patients&suspected&to&be&failing&
ART&&
o Discuss&factors&contributing&to&treatment&failure&&
o Review&adherence&for&the&client&and&propose&adherence&support&plan&
o Complete&clinical&summary&form&
• Commodity&Management&&
• Laboratory&Issues&
• Quality&of&Care&
o Support&Continuous&Quality&Improvement&through&review&of&plans,&
implementation&progress,&developing&action&plans&
4!
!
o Do&peer&chart&reviews&and&chart&audits&and&give&feedback,&develop&action&
plans&&&follow&up&plan&
o Conduct&mortality&review&
o Develop&data&quality&audit&feedback&and&action&plans&
• Signing&off&of&Clinical&Summary&Forms&
NB:&Good&documentation&is&critical&for&the&MDT&
&
Requirements:&
• Reference&materials&&
• Teaching&aids&
• SOPs&
• Book&for&MDT&minutes&
• Clinical&Summary&Form&
• Stationery&
&
.
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5!
Indications for Viral Load:
st nd rd
1) All!HIV'infected!children,!adolescents!and!adults!initiating!ART!(1 ,!2 !or!3 !line!ART!regimens)!should!receive!a!viral!
!
load!test!6!months!following!ART!initiation,!at!12!months!and!annually!
2)!Confirmation!of!treatment!failure!for!those!with!VL>1000!copies/ml!!
!
3)!All!HIV'infected!women!who!become!pregnant!while!on!ART!and!have!not!had!a!viral!load!test!in!the!preceding!6!
months!
4)!Before making any single-ARV drug substitution if the patient has been on ART for more than 6 months!!
!
Repeat viral load after 3 months of excellent adherence
NB:
! Plasma remains the preferred specimen type for viral load testing. Facilities in close proximity and
easy access to a testing laboratory should use plasma samples. Facilities with poor access or in remote
areas should use DBS.
• *Patients confirmed to have failed 2nd line ART treatment failure: Summarize case in the clinical summary
form provided by NASCOP and submit to ulizanascop@gmail.com for approval of Drug Resistance Testing
• NASCOP ART Therapeutics TWG will determine need for DR testing and advise the facility. Results of
HIV DR testing should be submitted to this TWG to determine ART regimen
• Meanwhile continue with current regimen
6
!
Viral.Load.Algorithm:.Additional.Notes.
.
.
! Always!consider!all!possible!causes!of!suspected!treatment!failure:!
• Poor!adherence!(consider!stigma,!disclosure,!side!effects!of!medications,!
alcohol!or!other!drugs,!mental!health!disorders,!religious!beliefs,!inadequate!
treatment!preparation,!etc.)!!
• Inadequate!dosing/dose!adjustments!(particularly!for!children)!!
• Impaired!absorption!(e.g.!chronic!severe!diarrhea)!!
• Drug`drug!interactions!!
• Drug`food!interactions!!
!
! If!2nd!viral!load!is!still!≥1,000!copies/ml!after.3.months.of.optimal.adherence,!
fill!in!the!Clinical!Summary!Form!and!send!it!within.one.week.via!email!to!
ulizanascop@gmail.com!for!consultation!
!
! National/Regional!Clinical!TWG!will!review!and!provide!feedback!for!next!steps!
in!patient!management!within.one.week!of!the!receipt!of!the!Clinical!Summary!
Form!
!
.
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7!
MINISTRY OF HEALTH
NATIONAL AIDS AND STI CONTROL PROGRAMME
CLINICAL SUMMARY FORM
Name of MFL
Facility Code
Patient CCC Date
no.
(do not write name)
Patient Details Date of Birth : Enrollment Date:
Clinical Evaluation: history, physical, diagnostics, working diagnosis (excluding the information in the table below)
Complete the table below chronologically, including all ART regimens and laboratory results (and any
previous history available for transfer-in patients)
Date CD4 HB CrCl/ Viral Weight (z- ARV Regimen Reason for Switch New OI or other
eGFR Load score/BMI clinical event
for children)
8
!
Likely root cause/s of poor adherence for this patient (e.g. stigma,
disclosure, side effects, alcohol or other drugs, mental health
issues, caregiver changes, religious beliefs, inadequate
preparation, etc.)
Date of Feedback:
9
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Adherence&and&Retention&Assessment&and&Support&
Introduction&
!
Adherence!counseling!support!and!patient!retention!is!an!extremely!important!
component!of!third!line!ART!in!the!management!of!clients!with!HIV.!It’s!importance!
is!emphasized!and!made!all!the!more!important!because!usually!they!have!already!
been!through!basic!ART!adherence!counseling!and!will!therefore!have!progressed!
through!from!1st!line!to!second!line!and!now!in!need!of!third!line!counseling.!Critical!
reasons!leading!to!this!development!poor!adherence!to!second!line!treatment!
independently!as!well!as!the!development!of!resistance!through!virological!
processes!of!the!virus!itself!regardless!of!their!adherence!practices!to!ART.!This!
therefore!requires!a!guidance!protocol!in!the!implementation!of!the!adherence!
counselling!support!to!ensure!optimal!compliance!to!the!third!line!ART.!A!further!
challenge!is!that!this!is!currently!the!last!line!of!defense!as!well!as!being!a!very!
expensive!undertaking.!In!order!to!ensure!adherence!is!carried!out!to!the!most!
efficient!and!effective!levels!there!is!need!to!address!concerns!of!the!actually!
capacity!of!the!providers!in!terms!of!training!and!experience,!the!requisite!intensity!
of!the!sessions!and!the!specialization!required!to!provide!this!support!at!this!level!
and!the!need!for!more!professional!oversight!of!this!service.!
!
This!module!sets!out!to!provide!guidance!on!the!adherence!and!adherence!support!
systems!to!ensure!client!adherence!to!3rd!line!ART.!
!
Purpose.
The!purpose!of!this!section!on!adherence!guidance!is!to!act!as!support!for!the!health!
care!provider!in!terms!of!highlighting!training,!experience!and!oversight!needs!for!
the!service!providers!as!well!as!guideline!on!delivery!of!services!to!ensure!provision!
of!quality!patient!education!and!counseling!for!patients!in!need!of!3rd!line!regimens.!
.
For.all.clients.on.third.line.regimen..
10!
!
Stress!that!this!treatment!options!remain!as!the!only!last!option!and!hence!need!to!
increased!effort!and!support!by!a!multidisciplinary!team!is!necessary.!Patient!
should!complete!three!adherence!sessions!and!develop!a!treatment!plan!prior!to!
initiating!third!line!treatment!
!!
Objectives&
The!three!(3)!main!objectives!of!drug!adherence!counselling!are,!to:!
(a)!Support!patients!in!making!informed!choice!on!HIV!3rd!line!treatment!according!
to!individual!needs!
(b)!Assist!patient!in!adopting!drug!adherence!behavior!
(c)!Enhance!patient's!ability!in!managing!and!maintaining!the!treatment!
!
Case&Manager&
Role.of.case.manager:!
Plans!MDT,!identifies!files!to!be!discussed,!presents!the!case!to!the!MDT,!coordinates!
assign!roles!to!the!team!members,!organizes!client!reminders!(SMS,!calling)!the!day!
before,!prepares!patient!files,!lead!in!defaulter!tracking,!plans!and!coordinates!home!
visits!(schedule!visits,!transport,!staffing!and!other!logistic).!
Adherence&assessment&and&enhanced&adherence&counselling&&
o To! avoid! 2nd! line! failure! and! need! to! switch! to! 3rd! line,! it! is! key! to! have! an!
adherence!support!strategy!in!place!from!the!start!of!ART!initiation,!with!means!
and! ! activities! adapted! to! the! different! stages! (initiation,! suspected! 1st! line!
failure,…)!Prevention!of!2nd!line!failure!starts!at!initiation.!!
11!
!
o Initial! adherence! assessment:! there! are! existing! adherence! scales,! e.g.! Morisky!
adherence.!They!are!however!not!very!reliable!in!routine!practice!with!patients!
most! often! over! reporting! self`adherence.! For! patients! with! suspected! 2nd! line!
treatment!failure!it!is!important!to!have!an!in!depth!adherence!assessment!done!
by! an! experienced! counsellor! as! part! of! the! Enhanced! Adherence! Counselling!
Sessions.!!!
counselling! is! to! assess! possible! barriers! to! adherence.! It! is! important! not! to!
focus! only! on! knowledge! of! HIV/AIDS! and! ARV! treatment! (cognitive! factors)!
but! to! asses! also! emotional,! socio`economical! and! behavioral! factors.! In!
addition!exploring!the!client’s!motivation!for!taking!medication!often!highlights!
reasons!for!non`adherence.!Barriers!to!adherence!should!be!explored!in!a!non`
judgmental! way! and! the! goal! of! the! sessions! is! to! construct! jointly! with! the!
patient!an!adherence!plan!with!concrete!objectives.!!!
o The!set!standard!recommends!three!Enhanced!Adherence!Counselling!sessions!
organized! on! a! monthly! basis,! but! more! often! if! needed.! If! the! adherence! is!
evaluated! as! adequate,! a! repeat! viral! load! will! be! done! after! three! months! of!
good! adherence.! Followed! by! a! fourth! counselling! session! to! conclude! on! the!
way!forward!based!on!viral!load!result.!!If!adherence!problems!persist,!further!
Enhanced!Adherence!Counselling!sessions!would!be!organized.!
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12!
!
Morisky&Medication&Adherence&Scales:&MMASI8&
Adherence.MMASY4.Score.MMASY8.ScoreMMASY4.MMASY8.
1) Do!you!sometimes!forget!to!take!your!pills?!
!
2)!People!sometimes!miss!taking!their!medications!for!reasons!other!than!
forgetting.!Thinking!over!the!past!two!weeks,!were!there!any!days!when!you!did!not!
take!your!medicine?!
!
3)!Have!you!ever!cut!back!or!stopped!taking!your!medicine!without!telling!your!
doctor!because!you!felt!worse!when!you!took!it?!
!
4)!When!you!travel!or!leave!home,!do!you!sometimes!forget!to!bring!along!your!
medicine?!
!
5)!Did!you!take!all!your!medicine!yesterday?!
!
6)!When!you!feel!like!your!symptoms!are!under!control,!do!you!sometimes!stop!
taking!your!medicine?!
!
7)!Taking!medicine!every!day!is!a!real!inconvenience!for!some!people.!Do!you!ever!
feel!hassled!about!sticking!to!your!treatment!plan?!
!
8)!How!often!do!you!have!difficulty!remembering!to!take!all!your!medicine?!
___A.!Never/rarely!
___B.!Once!in!a!while!
___C.!Sometimes!
___D.!usually!
___E.!All!the!time!
!
!
High!Adherence! 0!
! Medium!Adherence! 1!`!2!
Low!Adherence! 3!`!8!
!
!
!
!
Ref:!Morisky!DE,!Green!LW,!Levine!DM.!Concurrent!and!predictive!validity!of!a!self`reported!measure!
of!medication!adherence.!Med!Care.!1986;24:67–74.!
!
! !
13!
!
Table!1:!Enhanced!Adherence!Counselling!sessions!content!!
Session!1! " VL! education! review! and! discuss! with! patient! why! VL!
high!
" Review!treatment!literacy!
" Review! behavioral,! emotional! and! socio`economic!
barriers!to!adherence:!!
" Review!medication:!dosage,!timing,!storage!
" Mental!Health!screening!(screen!for!depression!using!
PHQ9!–!session!3)!
" Discuss!risk!reduction!(e.g.!substance!abuse)!
" Discuss!patient’s!support!system!
" Referrals!and!networking!
" Make! an! adherence! plan! with! the! client! based! on!
identified!issues!
Session!2!! " Review!plan!of!the!first!session!and!discuss!problems!
" Review!if!new!issues!emerging!
" Referrals!and!networking!!
" Make! an! adherence! plan! with! the! client! based! on!
identified!issues!!
Session!3! " Review!plan!of!the!first!and!second!session!!and!discuss!
problems!
" Identify!other!possible!gaps!and!issues!emerging!
" Make! an! adherence! plan! with! the! client! based! on!
identified!issues!
" Re`assess!adherence:!
" If! the! adherence! is! good! `! plan! next! VL! testing! after!
three! months! of! good! adherence! and! explain! possible!
ways! forward,! emphasizing! role! of! the! client! and! the!
health!facility!
" If! adherence! problems! persist:! plan! further! Enhanced!
14!
!
Adherence!Counselling!Sessions!
Session!4! " Discuss!VL!result!
" Plan!the!way!forward!!!!
!
!
Adherence&sessions&in&details&
Enhanced.Adherence.Sessions..1,.2,.3.and.4.
Target.group. All!2nd!line!patients!with!viral!load!>!1000!copies/ml!
Timing. On! the! day! the! patient! comes! for! scheduled! clinic!
appointment,!on!a!monthly!basis!
Duration. 15`30min!!!
Mode. Individual!–!with!patient!!and!counsellor!
SESSION.1.
Introduce.yourself.to.the.patient.and.provide.the.viral.load.result.
• Provide!VL!result!and!explanation!of!result.!You$have$a$detectable$viral$load.$This$means$your$
ART$is$not$effective$and$HIV$continues$multiplying$in$the$blood.$If$viral$load$is$detectable,$it$is$
important$ to$ determine$ whether$ the$ treatment$ is$ failing$ due$ to$ drug$ resistance$ or$ poor$
adherence.!
• How!does!the!client!feel!concerning!the!result?!
• Explain!the!process!of!enhanced!adherence.!Aim!of!the!session!is!to!identify!what!barriers!the!
client!has!to!adherence!and!find!solutions!
Assess.possible.barriers.to.adherence.
FIRST.ASK:!What!do!you!think!is!the!reason!for!your!high!viral!load?!!
Sometimes!the!patient!already!knows!why!his/her!Viral!Load!is!going!up.!Here!you!can!give!them!a!
chance!to!give!their!own!explanation.!Often!they!will!already!tell!you!at!this!point!that!they!are!
struggling!with!their!adherence.!!
If!they!really!don’t!know!why!their!Viral!Load!is!high!you!can!say:We$notice$that$when$people$sometimes$
forget$to$take$their$ARVs$everyday$it$gives$the$virus$a$chance$to$grow,$do$you$think$that$you$sometimes$
forget?!
Cognitive.barriers.(ART/HIV.knowledge).
• What!is!HIV?!What!is!AIDS?!
• What!is!immune!system!and!CD4!cells?!
• What!are!ARVs!and!how!do!they!work?!
• What!should!you!not!do!when!taking!ARV?!What!are!the!side!effects?!
• Why!is!it!important!to!be!adherent?!And!How?!
• Why!do!you!have!to!come!on!review!dates?!What!to!bring?!
Behavioural.barriers:.
• Review!how!client!takes!drugs!
o How!does!treatment!fit!in!daily!routines?!!
15!
!
E.g.!Establish!with!the!patient!whether!the!time!they!are!meant!to!take!their!medication!is!appropriate!
or!whether!the!time!is!a!problem.!For!example!if!the!patient!has!chosen!9pm,!but!is!already!asleep!in!
bed!by!9pm,!then!that!is!not!a!good!dosing!time.!!If!the!time!is!a!problem!then!determine!a!new,!more!
appropriate!time!with!the!patient!based!on!their!schedule.!
o What!reminder!tools!do!you!use?!(!e.g!mobile!phone!alarm)!
o What!do!you!do!in!case!of!visits,!travel,!side`effects?!
Travelling!is!always!risk!for!poor!adherence!or!default!of!treatment.!Encourage!patient!to!plan,!to!make!
sure!they!have!enough!medication!on!hand!before!and!to!remember!to!pack!it!!
Make!sure!that!all!relevant!information!is!on!the!patients!appointment!card!and!explain!to!that!if!they!
are!ever!away!from!home!and!they!run!out!of!medication!that!they!must!go!to!the!closest!ARV!clinic!and!
show!their!appointment!card!!
o What!do!you!do!in!case!of!side!effects?!
!
Ask!patient!if!he!sometime!find!difficult!to!take!ARV!because!of!the!side!effects.!Ask!him!how!does!he!
manages!side!effect!and!if!it!does!influence!the!way!he!take!his!drugs.!
o What!are!the!most!difficult!situations!for!you!to!take!drugs?!
• How!is!your!life!style!:!e.g!smoking,!exercises!!
• Check!for!alcohol!or!drug!use!
Ask!the!patient!in!a!casual!way!(not!in!an!accusing!way)!if!they!sometimes!use!substances;!emphasize!
treatment!planning!in!case!they!do:!!“Taking$alcohol$or$drugs$sometimes$makes$it$difficult$for$us$to$
remember$to$take$treatment.$If$possible$it$is$best$to$limit$your$use,$$but$if$you$are$planning$to$take$any$
alcohol$or$drugs,$it$is$important$to$plan$ahead$so$that$you$don’t$forget$to$take$your$treatment”!!
“If$you$feel$your$alcohol$or$drugs$use$is$affecting$your$adherence,$would$you$feel$ready$to$be$referred$to$
some$professionals$that$may$help$you$to$work$on$that$problem?”$(refer$this$patient$to$your$version$of$
Alcoholics$Anonymous).$!
Emotional.barriers:.. .
• How!do!you!feel!about!taking!drugs!every!day?!
• What!are!your!ambitions!in!life?!!.
E.g.!Use!motivation!cards:!Ask!the!patient!to!think!of!their!own!personal!goals!/!dreams!for!their!future.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!.
What!are!the!3!most!important!things!they!still!want!to!achieve!in!their!future.!Have!them!write!it!in!their!
own!language!on!a!notecard.!Encourage!the!patient!to!read!the!notecard!every!day!preferably!right!before!
they!take!their!medication.!!!!! ! !
• Mental!health!screening:!!
Depression!is!an!important!reason!of!non`adherence.!If!the!patient!is!reporting!loss!of!
interest!or!pleasure,!feeling!down!or!depressed!it!is!advised!to!screen!the!patient!using!PHQ9!
(session!3).!
! !
SocioYeconomical.barriers..
• Disclosure!to!partner!/!family!/!friends!or!co`workers!
Do$you$have$any$people$in$your$life$who$you$can$talk$to$about$your$HIV$and$ARVs?$
Suggest!to!the!patient!that!they!enlist!the!support!of!their!family,!friends,!and!coworkers!in!reminding!
them!to!take!their!medication!if!they!have!not!already!done!so.!
• Support!from!treatment!buddy!
o If!client!came!with!treatment!buddy,!assess!input!of!relative!
o If! client! did! not! come! with! treatment! buddy,! explain! the! role! on! treatment! and!
encourage!client!to!come!with!a!person!they!trust!next!visit.!
• Support!in!family/community/support!group!
16!
!
• Profession,!income!generating!resources!
• Specific!barriers!to!come!to!health!centre!on!regular!basis!(transport,…)!
• Stigma!and!discrimination!
• Religious!beliefs!
Referrals.and.networking!
• Confirm!in!the!patient!file!if!the!patient!has!been!referred!to!other!services.!This!includes!
referrals!to!social!services,!psychology!services,!nutrition!services,!medical!clinics,!substance!
abuse!groups,!etc.!
Ask!patient!if!they!attended!the!appointments,!check!in!on!their!experience!with!the!referral!
services!and!re`organize!referral!if!necessary!!
Elaborate. an. adherence. strategy. with. the. client. to. overcome. identified. difficulties.! For!
example:!
• Behavioural!barriers:!use!of!reminder!tool,!pill!box,!daily!planning,!change!routines!
• Socio`economical!barriers:!move!on!in!disclosure!process,!identify!treatment!buddy,!refer!to!
support!group,!refer!to!CBO/NGO!to!learn!about!income!generating!activities!
• Emotional!barriers:!emotional!support!or!refer!to!clinician!for!mental!health!management!
SESSION.2.–.four.weeks.after.session.one.
Review.plan.of.the.first.session.and.discuss.problems.
• Review! the! client’s! barriers! to! adherence! documented! during! the! first! session! and! if!
strategies!identified!have!been!taken!up.!If!not`!why!not!and!make!a!concrete!plan.!
Review.if.new.issues.emerging!
Referrals.and.networking!
• Follow`up!on!referrals!to!other!services!(social!services,!psychology!services,!nutrition!
services,!NCD!clinic,!substance!abuse!groups,!etc.)!
o Identify!patients!needing!home!visits!!
!
Review.adherence.strategy.with.the.client.to.overcome.identified.difficulties.!
o Give!another!short!motivational!speech!on!how!you!believe!in!the!patient!!You!know!they!can!
do!this!!Together!you!will!make!sure!that!they!suppress!their!viral!loads!!!
o Agree!on!follow!up!date!
.
SESSION.3.–.four.weeks.after.session.two.
Review.plan.of.the.first.and.second.session.and.discuss.problems.
• Review! the! client’s! barriers! to! adherence! documented! during! the! first! session! and! if!
strategies!identified!have!been!taken!up.!If!not`!why!not!and!make!a!concrete!plan.!
Review.if.new.issues.emerging!
Re`asses!adherence!
" If!the!adherence!is!adequate!`!plan!next!VL!testing!after!three!months!of!adequate!adherence!
and! explain! possible! ways! forward,! emphasizing! role! of! the! client,! the! support! systems! and!
the!health!facility.!
" If!adherence!problems!persist:!plan!further!Enhanced!Adherence!Counselling!Sessions!
Plan.a.way.forward.
Start!discussing!what!might!happen!if:!
17!
!
“If$your$results$come$back$and$your$VL$is$less$than$1000$–$you$will$continue$with$same$ARTs”.$Adapt$to$
individual$patient$/$context$
“If$your$viral$load$is$still$elevated$we$will$repeat$your$viral$load$again$in$3$months,$or$we$can$also$do$a$
genotype$test$to$check$if$your$HIV$has$become$resistant$to$your$current$ARVs”.$Adapt$to$individual$
patient$/$context$
SESSION.4.–.to.be.done.the.month.after.viral.load.was.repeated.
Step.1:..Discuss.viral.load.results.
.
If.suppressed.VL.<.1000,!!CONGRATULATE!the!patient!!!!
• Explain!the!way!forward!–!will!continue!with!same!ART!and!have!next!VL!according!to!
national!guidelines.!
!
If.not.suppressed.then:!
• Refer!to!Viral!Load!flowchart/national!guidelines!to!assess!next!steps!
• Patient!to!be!discussed!in!MDT!meeting!and!case!to!be!referred!to!regional!/!national!TWG!
!
Mental&Health&Screening&
Patient.Health.Questionnaire.(PHQ9).
NAME:._____________________.......Date:.____________.
*.
Over$the$last$2$weeks,$How$often$have$you$been$ ! ! ! !
bothered$by$any$of$the$following$problem?$
2.Feeling!down,!depressed,!or!hopeless! 0. 1. 2. 3.
If$one$of$the$above$symptoms$are$present$more$ . . . .
than$half$of$the$time,$go$on$with$the$following$
questions$:$
3.Trouble!falling!or!staying!asleep,!or!sleep!so! 0. 1. 2. 3.
much!
4.Feeling!tired!or!having!little!energy! 0. 1. 2. 3.
5.!Poor!appetite!or!overeating! 0. 1. 2. 3.
6.Feeling!bad!about!yourself!or!that!you!are!a! 0. 1. 2. 3.
failure!or!have!let!yourself!or!your!family!down!
8.Moving!or!speaking!so!slowly!that!other!people! 0. 1. 2. 3.
could!have!noticed!.Or!the!opposite`!being!so!
fidgety!!or!!restless!that!you!have!been!moving!
around!a!lot!more!that!usual!
18!
!
9.Throughts!that!you!would!be!better!off!dead!or! 0. 1. 2. 3.
of!hurting!yourself!in!some!way!
Add!columns!!!:!!! ! ! ! !
TOTAL.:.. ! ! ! !
!
10:!If!you!checked!off!any!problems,!how!difficult!have!these!problems!made!it!for!you!to!do!your!
work,!take!care!of!things!at!home,!or!get!along!with!other!people?!
Not!difficult!at!all:!_____!
Somewhat!difficult:!_____!!
Very!difficult:!_________!
Extremely!difficult:!_________!!!
if!you!faced!any!difficulty,!did!it!occur!for!two!years!or!more!?!______!
!
A.patient.is.considered.as.having.signs.of.depression.if:.
PHQ9..score. Provisional.diagnosis. recommendation.
5`9! Minimal!symptoms! Support!and!educate!to!call!if!worse!
10`14! Minor!to!mild!depression.. Support!and!watchful!waiting!
or## Reassess!in!one/two!weeks!
chronic.depression! !
(symptoms!lasting!for!two! Consider!starting!treatment!
years)!
15`19! Major!depression! Refer!to!clinical!officer!/!psychologist!(need!for!
specific!treatment)!
>!20! Severe!depression! Major!impairment,!need!for!active!treatment!
!
• For.major,.severe.and.chronic.depression,.treatment.and.follow.up.consists.on.:.
1. regular.supportive.counselling.
1. Reassure!patient!about!his!(her)!symptoms,!build!a!trustful!and!confidential!
relationship!
2. Evaluate!depression!(when!did!it!start,!release!context,!etc…)!!!
3. Asses!functional!impairment!:!ask!for!question!10,!be!sure!all!symptoms!are!
lasting!for!more!than!two!weeks!
4. Reassess!patient!after!one!week!(counselling!session!and!PHQ9)!if!PHQ9!
<17.!
5. provide!regular!counselling!sessions!during!medical!treatment!!
!
2. Refer.to.clinical.officer/medical.doctor.(++.if.score.>.17).who.will.consider.a.
treatment.of.depression...
.
Note:$Grieving$is$a$personal$process$that$has$no$time$limit,$nor$one$“right”$way$to$do$it$(Axelrod$2015).!
The! patient! may! be! in! any! of! the! five! stage! of! the! Kbuller! loss! stage! of! grief! (denial! and! isolation,!
anger,! bargaining,! depression! and! acceptance)!! which! in! most! cases! recur! ! from! time! to! time! and!
need!to!be!handled!before!the!client!get!worse.!!
Ref:!Axelrod.!J.!(2015).The!five!stages!of!loss!and!grief!http://psychcentral.com/lib/the`5`stages`of`
loss`and`grief/000617!!!
19!
!
Enhanced&Adherence&Counseling&Sessions&Documentation&
The!adherence!counseling!session!should!be!documented!on!recto`verso!patient!
form!(see!the!form!(Session!4)!below).!It!is!important!to!write!up!information!
collected!during!the!sessions!in!the!patient’s!file!in!order!to!ensure!good!follow`up!
and!communication!between!the!MDT!members.!It!is!also!necessary!to!have!a!
systematic!planning!and!follow`up!of!the!Enhanced!Counseling!Sessions;!this!will!be!
followed!up!by!the!case!manager!appointed!by!the!MDT.!!
NB:!It!is!preferable!clients!with!suspected!2nd!line!failure!to!be!attended!by!the!same!
counselor!in!order!to!ensure!continuity.!
Adherence&Counseling&for&Caregivers&and&Children!
The!main!aim!is!to!support!the!caregiver!through!collaboration!with!the!MDT,!to!
address!the!concerns!which!are!barriers!to!adherence.!The!baseline!in!preparation!
to!3rd!line!treatment!should!be!based!on!the!reason!of!what!were!the!causes!of!the!
child!failure!on!2nd!line.!Working!with!direct!caregiver!is!the!best!so!that!their!
worries!and!concern!can!be!address!directly.!
The!social!worker!or!nurse!counsellor!should!assist!caregivers!to:`!
• Address!the!child’s!needs!
• Develop!a!plan!addressing!those!needs!
• Link!up!with!community`based!services!for!children!
• Disclose!the!child’s!status!gradually!in!an!age!appropriate!way!
In!providing!support!for!adherence,!the!social!worker!or!nurse!counsellor!should!
assess:`!
• The!caregivers!level!of!comfort!with!the!medication!
• Caregiver’s!cognitive/psychological!capabilities!
• Caregiver’s!awareness!of!the!risk!to!the!child!as!a!result!of!inadequate!adherence!
• Involvement!of!other!caregivers!in!the!child’s!therapy!
• The!understanding,!level!of!comfort!and!capabilities!of!other!caregivers.!
Preparation.
• Explain!about!the!expected!changes!in!physical!wellbeing!to!the!care!giver.!
• Importance!of!adherence!despite!improvement.!
• !It!should!be!well!understood!that!on!other!treatment!option!available.!
• Regular!visits!to!clinic!to!monitor!physical!and!psychological!status.!
20!
!
• Importance!of!regular!laboratory!check`ups!to!monitor!biological!markers(!eg!
various!lab!test,!CD4!and!viral!load)!with!ART.!
• Recap!on!adherence!promotion!for!positive!living!e.g.!nutrition,!positive!behavior!
change!etc.!
• Family!to!identify!the!most!appropriate!adherence!promotion!strategy.!
• Address!important!pending!issues!e.g.!appropriate!care!giver!to!support!adherence.!
• Get!assent!from!child!(10!years!and!above)!and!consent!from!the!care!giver/s!to!
commence!3rd!line!ART.!
• Start!3rd!line!ART!if!criteria!has!been!met!
• Make!a!follow!up!plan!
The!adherence!counseling!process!should!follow!the!4!adult!adherence!counseling!
sessions!but!always!consider!the!above!points!when!dealing!with!a!child!and!a!
caregiver.!
Adherence&Counseling&for&Adolescents&
Follow!the!4!sessions!for!adult!counseling!and!pay!special!consideration!in!the!
following:`.
1. Their!developmental!stages!and!their!emotional!state..
2. Their!cognitive!understanding!and!self`perceptions..
3. Stigma&!discrimination..
4. Social!support!system.!(family!and!peers).
5. Goals!and!motivation!in!life..
. .
21!
!
Enhanced&Adherence&Counselling&Form.(to.be.filed.by.the.counsellor).
For#each#session,#assess#major#barriers#to#adherence#(cognitive,#behavioural,#emotional,#socio7
economic)#
Date.of.1st.session:.. ARV!intake!demonstration!by!patient/caretaker!done?!Yes!□! !No!□!
! MMAS`8:!!
Summary:..
.
.
.
Treatment!motivation:!______________________________________________________________________________________!
Adherence!plan:!____________________________________________________________________________________________.
.
Your.impression.about.patient’s.adherence:.
□!Likely!to!be!adequate! □!Likely!to!be!NOT!adequate!(relevant!barriers!identified)! ! !
□!Clearly!inadequate!(defaulter).
.
Date.of.2nd.session:.. . Summary:.
_____________________________________________________________________.
__________________________________________________________________________________________________________. .
Adherence!plan:.____________________________________________________________________________________________.
.
.
Date.of.3rd.session:. . Summary:.
____________________________________________________________________.
___________________________________________________________________________________________________________.
Adherence!plan:.____________________________________________________________________________________________.
Did.the.client.attend.all.three.appointments?.Yes!□! !No!□.. .
If!no,!any!reason?!________________________________________.
Impression.about.patient’s.adherence:..
□!Likely!to!be!adequate! □!Likely!to!be!NOT!adequate!(relevant!barriers!identified!and!not!cleared)! !
□!Clearly!inadequate!(defaulter)!
Major.remaining.barriers.identified.
• Cognitive.. . Yes!□! !No!□! If!yes:!_______________________________________.
• Behavioural.. Yes!□! !No!□! If!yes:!_______________________________________.
• Emotional. . Yes!□! !No!□! If!yes:!_______________________________________.
• SocioYeconomic. Yes!□! !No!□! If!yes:!_______________________________________.
If$adherence$is$likely$to$be$adequate:$plan$repeat$viral$load$$
If$adherence$is$likely$to$be$not$adequate:$$repeat$viral$load$should$be$deferred$and$Enhanced$Adherence$
Counselling$$extended.$Discuss$with$MDT$team$
.
Date.of.extra.session.(if.any):.. . Summary:.
______________________________________________________________.
___________________________________________________________________________________________________________.
Adherence!plan:!____________________________________________________________________________________________.
.
.
Date.of.extra.session.(if.any):.. . Summary:.
______________________________________________________________.
___________________________________________________________________________________________________________.
Adherence!plan:._____________________________________________________________________________________________.
22!
!
3rd&line&ART&client&education&and&counselling&sessions&&
Figure!2:!Overview.3rd.line.ART.client.education.and.counselling!NB:!It!is!
important!for!patient!on!3rd!line!to!be!attended!by!the!same!counsellor!in!order!
to!ensure!continuity.!Ideally!it!should!be!the!counsellor!who!has!done!the!
enhanced!adherence!counselling!sessions.!It!is!also!important!to!involve!the!
clinician!and!good!to!have!the!counsellor!and!clinician!address!the!patient!
together.!
Key&Messages&on&Treatment&Failure&and&Use&of&Viral&Load&
!
Topic. Messages. .
You! are! taking! ARVs! on! a! daily! basis! to! fight!
HIV!in!your!body.!Due!to!the!ARVs!the!number!
What! is! the! goal!
of!HIV!copies!will!decrease!in!your!body,!while!
of!ART!therapy?!
your!soldiers!(CD4s)!will!increase!and!protect!
you!from!diseases.!
A! viral! load! test! measures! the! number! of! HIV!
viruses! in! your! blood.! The! test! is! done! by!
What! is! a! viral!
taking!a!sample!of!blood!by!a!finger!prick!or!by!
load!test?!!
drawing! blood! and! sending! to! the! laboratory!
for!testing.!!
All! those! on! ART! treatment! will! be! offered! a!
viral!load!test!as!part!of!your!routine!follow`up!
at! 6! months,! 12! months! and! then! yearly! on!
ART!or!according!to!your!health!condition.!You!
can! always! remind! your! health! worker! for!
When! to! have! a!
your! need! to! get! a! viral! load! test! or! ask! them!
viral!load!test?!
for!the!results!of!your!test.!!
It! is! important! not! to! miss! your! appointment!
date!for!your!viral!load!test!and!to!come!for!the!
results! on! time! as! instructed! by! your! health!
care!worker.!
Undetectable! viral! load! means! that! you! have! !
less!HIV!in!your!blood.!
Undetectable! viral! load! in! the! blood! does! not!
mean!you!no!longer!have!HIV,!but!the!amount!
What! does! an!
of! HIV! in! your! blood! is! ! too! low! to! be!
undetectable!viral!
measured.!
load!result!mean?!
Undetectable! viral! load! means! your! treatment!
is! working! well,! because! your! ARV’s! are!
fighting! HIV! and! thus! reducing! the! amount! of!
HIV!in!your!blood.!
!
!
!
! !
23!
!
Topic. Messages. .
Detectable! viral! load! means! that! there!
is!a!lot!of!HIV!in!your!blood.!!
What! does! a! When! your! viral! load! is! detectable,! the!
detectable! a! health! worker! will! suspect! treatment!
viral! load! failure.! Treatment! failure! means! your!
>1000! HIV!treatment!is!no!longer!working!as!it!
copies!result! should:!HIV!is!multiplying!in!your!body!
mean?! while! your! soldiers! (CD4)! reduce! in!
number!and!you!become!more!likely!to!
develop!opportunistic!infections.!!
You! have! problems! taking! your!
treatment! on! a! regular! basis:! stopping!
to! take! your! pills! for! a! while,! skipping!
many!doses.!
What! could!
You! have! developed! resistance! to! the!
explain! a!
treatment! which! means! that! the! HIV! in!
detectable!
your! blood! has! changed! and! your!
viral!load?!
treatment! is! no! longer! able! to! fight! the!
changed!HIV.!!The!resistant!HIV!is!now!
multiplying!rapidly!in!your!blood.!!
! !
Together! with! the! counsellor! you! will!
identify! the! reason! for! your! detectable!
What! to! do! viral! load! and! look! at! ways! to! address!
when! you! possible!adherence!problems.!!
have! a! If! your! viral! load! continues! to! be!
detectable! detectable! and! there! is! no! longer! any!
viral!load?! treatment! adherence! problem,! you!
might! be! changed! to! another! type! of!
drug!treatment.!
How! to! Adhere!to!your!ARV!treatment!in!order!
avoid! to! maintain! undetectable! viral! load,! a!
resistance! strong!immune!system!and!a!long!life.!!
and!
treatment!
failure?!
!!
Adherence&support&systems&
!
Adherence!support!systems!will!need!to!be!adapted!to!patient’s!specific!needs!and!
the! context.! Special! attention! needs! to! be! given! to! adolescents,! mental! health!
patients!and!patients!with!substance!use.!!
Figure!3:!Adherence!support!systems!
24!
!
treatment!
buddy!
MDT! home!visit!
client!
support!
DOTs!
group!
!!
Figure!3:!Adherence!support!systems!
a. Support.client.to.identify!a.treatment.buddy.
" Discuss! with! the! client! the! importance! and! the! role! of! a! treatment! buddy! or!
caregiver.! This! a! person! who! should! be! able! to! provide! the! needed! moral! and!
social!support!and!!even!remind!the!client!to!take!medication.!!
" They! may! also! assist! them! back! to! the! clinic! when! they! are! very! sick! or! convey!
information! to! the! clinic! when! they! are! admitted! or! bedridden! at! home! and!
provide!support!at!home!when!they!are!very!weak.!Having!the!names!and!contacts!
The!treatment!buddy!or!caregiver!should!be!invited!to!at!least!one!of!the!3rt!line!
education!and!counselling!sessions.!!
b. Provide.Directly.Observed.therapy.(DOTS)!!
25!
!
The!Multidisciplinary!team!determines!how!and!by!whom!direct!observed!
therapy!would!be!carried!out!
" DOTs!providers!include:!health!care!provider,!CHW!or!peer!educators,!caregivers!
or!family!members!
" Steps:!
.
• confirm&venue&for&3rd&line&ART&DOTs&in&readiness&for&
step&1& treatment&&
• Build&capacity&of&the&DOT&providers&
step&2&
• Confirm&and&introduce&to&the&client&the&CHW&or&health&
step&3& worker&who&will&administer&the&dots&
• Develop&data&capture&mechanism&to&inform&MDT&
step&4&
!
2. Enroll.the.client.to.a.support.group.
" Support!groups!give!confidence!and!provided!emotional!support!for!the!patients!on!
3rd!line.!
" Support! may! improve! patient’s! experience! of! HIV`status! disclosure! and! possibly!
even!promote!disclosure.!!
" Provide!platform!for!education!sessions!by!specialists!and!clients!sharing!amongst!
themselves.!
" Provides!social!support!to!group!members!
3. Home.visits.
" Home!visit!team!of!two!to!be!formed!by!MDT!(nurse/counsellor,!social!worker,!peer!
educator/CHW)!!
" All! patients! on! 3rd! line! require! a! home! visit! to! enhance! psychosocial! support! and!
enhance!adherence!!
" Steps:!
26!
!
NB:!Provide!referrals!for!services!that!address!factors!that!may!impede!adherence,!
such! as! lack! of! health! insurance! or! other! resources! to! cover! ART! costs,! drug! and!
alcohol!use!rehabilitation,!and!mental!illness.!
.
.
.
.
. .
27!
!
.
Client$Name:#################################################Tel$No#######################################Sex:$M$$$$$$$$$F#
Family$Member:$ Tel$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$File$no.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Physical$landmark:$
This!checklist!is!not!all!inclusive!but!highlight!critical!areas!specific!which!can!affect!
3rd!line!ART!adherence.!
! Critical.areas.for.clients.to.enhance.on.third.line. A! B!
1! Current!Status!of!the!client:!assess!the!activities!of!daily!living!e.g! ! !
feeding!grooming,!toileting…..!
2! Availability!of!basic!needs!.e.g.!clothing,!shelter,!food!(!observe!&! ! !
Discuss)!
3! Disclosure`!Assess!and!Supported!disclosure!as!required!(!Discuss)! ! !
4! Adherence`!Assess!for!common!condition!which!affect!adherence!e.g.! ! !
pain!
5! !Immediate!Social!support`!Available!social!support!structures!e.g.! ! !
stable!and!supportive!family!(observe,!discuss)!
6! Community!support!system!e.g.!community!leaders,!community! ! !
support!groups!
7! Facilities!for!linkage!for!required!service!which!are!not!provided!like! ! !
Spiritual,!legal!or!nutrition!(inquire!,!observe,!Link)!
8! Emotional!problems!`!Screen!and!support!for!mental! ! !
health/emotional!problem(!observe/discuss)!
9! Drug!toxicity`!side!effects,!ADRs!(observe!&!discuss)! ! !
10! In!case!of!stress!full!situation!such!as!loss!through!death!of!loved,! ! !
offer!or!refer!for!grief!counselling!
!
Key:!A:!Absent!!B:!Present!
For!each!section!1`!7!if!absent,!counsel,!educate!and!refer!the!client!appropriately.!
!For!each!section!8`10!if!present!counsel!and!refer!the!client!accordingly.!
!
The!visiting!team!should!be!able!to!handle!at!least!three!identified!issues!based!
priority!and!refer!other!needy!issues!which!are!not!dealt!with.!This!also!forms!the!
basis!for!the!frequency!of!home!visit!!!
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Patient Management Protocol
(These are minimum standards for management of a patient on 3rd line ART and do not replace
the essential package of services for PLHIV)
Adherence Support
o Conduct patient education on the new ART regimen; treatment goals, dosing,
drug interactions and potential side effects and adverse events
o Conduct adherence assessment and counseling
o Link patient to adherence support systems
Clinical Assessment
o Take history and conduct physical examination
o Complete Clinical Encounter Form and MOH 257 (blue card)
o Manage any co-infections and co-morbidities
o Review for potential drug interactions and contraindications
o Conduct adherence assessment and review adherence support systems
o Reinforce patient education messages on new regimen
Currently no further treatment options
Need for perfect adherence (>95%)
Dosing
Potential side effects and what the patient should do
o Prescribe new regimen for 2 weeks
o Confirm dosing as per the weight (for 18 years and below)
o Continue other medication e.g. CPT, IPT
Dispensing
o Confirm ARV dosing as per the weight
o Conduct medication use counseling
o Dispense 3rd line ARVs for 2 weeks
Community Follow up
o Link all patients to support group, CHW/CHEW
o Plan for home visits as required
29
Patient Follow Up After Treatment Initiation
Frequency
o First follow-up should be within 2 weeks of initiation of 3rd line ART
o Subsequent visits should be monthly (or more frequent) until confirmed viral
suppression at 6 months
o Thereafter, follow-up can be 1-3 monthly
Triage
Record vital signs and take action as needed
Adherence Support (adherence should be reinforced during every clinic visit, in
addition to enhanced adherence counseling sessions)
o Review and address knowledge deficits on new regimen
o Confirm understanding of adherence, conduct adherence assessment, and
reinforce key adherence messages
o Document reasons for missed doses and manage obstacles to perfect adherence
o Review and reinforce adherence support systems
Clinical Assessment
o Take history and conduct physical examination
o Complete Clinical Encounter Form and MOH 257 (blue card)
o Manage any co-infections and co-morbidities
o Evaluate for potential drug interactions
o Evaluate for and manage any drug side effects and adverse events
o Conduct adherence assessment and review adherence support systems
o Reinforce patient education messages on new regimen
Review and address knowledge gaps on ART regimen
Need for perfect adherence (>95%)
Dosing
Potential side effects and what the patient should do
o Prescribe 3rd line ARVs
Laboratory Monitoring
o Baseline and routine monitoring should be based on clinical symptoms
o Hb should be done at baseline because RAL and ETR may rarely cause anemia
o ALT should be monitored quarterly in mild to moderate underlying chronic liver
disease or Hepatitis B/C co-infection
o Creatinine should be monitored quarterly in mild to moderate Kidney Disease
o Blood Sugar and lipid profile should be monitored at baseline and annually
o Creatinine Kinase should be done in suspected rhabdomyolysis
o Viral load should be conducted at month 6, 12 and annually thereafter
Dispensing
o Confirm ARV dosing as per the weight
o Conduct medication use counseling
o Dispense 3rd line ARVs
Community Follow up
o Review linkage to community adherence support systems
o Conduct home visits as required
o Continue DOTS
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Clinical Encounter Form Date:_____/______/_______
DD MM YYYY
Name: Clinic Number: Facility Name:
MFL Code:
Known comorbidities:
Current Medications
ARVs (specify): TB treatment (specify):
Food By Prescription (specify): Treatment type: O 1st line TB
CTX O 2nd line TB (MDR)
Antibiotic (specify): Other (specify):
Adherence support systems in place (specify):_________________________________
Adherence assessment: O Good ( 95%) O Fair (85-94%) O Poor ( 84%)
ARV Adherence
Has the patient defaulted in the past 3 months? O Yes O No
Adherence counseling conducted today: O Yes O No
Any suspected side effects/toxicities related to third line ARVs?
Drug Toxicities
O Yes (specify): O No
TB Screening & TB screening outcome: O Positive O Negative
Prophylaxis On IPT? O Yes O No (specify reason):________________________________________
Vitals Examination Comments/Description
General Appearance
Temp: _____ o C
Eyes, Ears, Nose, Throat
Pulse: ______b/min Lymph Nodes
BP: ___/___mmHg Respiratory
Cardiovascular
Today’s weight: ____kg
Gastrointestinal
Height: ______cm Neurological
BMI / Z-Score: _________ Musculoskeletal
Genitourinary
Resp. rate: ____breaths/min
Skin
Other
Investigations Most Recent Investigation Results (Date, Value)
Ordered Today None
Viral load: Blood Sugar:
Creatinine: Total Cholesterol:
ALT: Other (specify):
HB:
Impression (including any new WHO condition):
Plan:
Commodity&Management&Standard&Operating&Procedures&
Requesting&for&Third&Line&Medicines&for&New&Patients&
Objective: To describe the procedure for requesting third line ARVs for new patients.
Responsible persons:
• Comprehensive!Care!Centre!in`charge.
• Pharmacist/Pharmaceutical!technologist!responsible!for!making!requests!for!
ARVs!and!OI!drugs!!
Tools needed:
• Clinical Summary Form
• DST/DRT report (where available)
Procedure:
• A duly filled patient clinical summary form, with drug dosages for the proposed
regimen should be submitted by the facility to NASCOP using the email
ulizanascop@gmail.com
• Patient (s) to continue on failing 2nd line with intensified adherence efforts
(adherence counseling, Directly Observed Treatment Support (DOTS) and home
visits)
• Regimen proposed by facilities to be reviewed by the National Clinical Technical
Working Group (TWG)
• Facility to be notified by NASCOP on approved regimen, medicines to be
supplied and expected date of delivery
• The initial medicine supply to be for 3-months for each patient identified
• Subsequent resupplies to be based on consumption and request reports submitted
monthly to KEMSA
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Documenting&the&Dispensing&of&Third&Line&Medicines&
Objective: To describe the procedure for documenting the dispensing of third line
medicines
Responsible persons:
• Pharmacist/Pharmaceutical technologist or other health providers responsible for
dispensing ARVs and OI Drugs
Tools needed:
• MOH 367A: DAR for ARVs and OI Drugs (Version September 2014)
• Electronic ART dispensing tool, where available
Figure 01: Cover page of Version September 2014 DAR for ARVs and OI Drugs
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Procedure
• Each dispensing event for third line medicines should be documented using the
DAR for ARVs and OI (Version September 2014) or where available, an
electronic ART dispensing tool
• All fields should be duly filled for each dispensing event
• Each page of the manual DAR for ARVs and OI should be summarized once all
the rows have been filled
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Reporting&Consumption&and&Resupply&Requests&for&Patients&on&Third&Line&
Treatment&
Objective: To describe the procedure for reporting consumption and resupply requests
for patients on third line treatment.
Responsible persons:
• Pharmacist/Pharmaceutical! technologist! in`charge! of! making! requests! for!
ARVs!and!OI!Drugs!
Procedure
• Facilities with patients on 3rd line to request for 3rd line ARVs monthly using D/F-
CDRR and D/F-MAPS (Version September 2014, manual or electronic)
• The correct adult or paediatric third line regimen code to be reported. Third line
regimen codes for adults and pediatrics are defined as:
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Figure 02: Cover page of Version September 2014 F-CDRR (standalone sites)
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Figure 03: Cover page of Version September 2014 F-MAPS (standalone sites)
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Third&Line&ARV&Drug&Information&
RALTEGRAVIR&(Integrase&Inhibitor)&
A. DOSAGE FORMS, STRENGTH AND PACKAGING
B. DOSING RECOMMENDATIONS
1. For children ≥ 4 weeks old and weighing 3 kg to < 20 kg, use oral suspension, if
available
2. Children aged 2 to < 12 years or < 25 kg, use the chewable tablet as per dosing table
below
3. Patients ≥ 12 years or ≥ 25 kg: 400 mg film-coated tablet twice daily
Note: The film-coated tablet is the recommended formulation for patients weighing ≥ 25
kg (regardless of age); if unable to swallow a film-coated tablet, the chewable tablet
regimen should be considered.
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C. SPECIAL INSTRUCTIONS
" Can be given without regard to food
" Avoid use of aluminum and magnesium-containing antacids (they reduce Raltegravir
plasma levels)
" Chewable tablets may be chewed or swallowed whole. Film coated tablet should be
swallowed whole.
" DO NOT interchange film-coated tablets, chewable tablets and oral suspension
(the three formulations are not bioequivalent)
" Chewable tablets should be stored in the original package with desiccant to protect from
moisture
" Close monitoring of weight required at every visit to prevent underdosing or overdosing
" Oral suspension is contraindicated in neonates.
42!
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Consult senior clinician or National HIV Clinical Support Center if any concerns about
adverse drug reactions.
F. DRUG INTERACTIONS
Note: For more information on drug interactions, visit online resources such as;
www.medscape.com/drug-interactions or www.drugs.com/drug-interactions.
DARUNAVIR&(WITH&RITONAVIR)IProtease&Inhibitors&&
Darunavir is a Protease Inhibitor and is not currently available as a co-formulation
with ritonavir. It should always be co-administered with ritonavir. Ritonavir is
available as a tablet or liquid formulation.
A. DOSAGE FORMS, STRENGTH AND PACKAGING
B. DOSING RECOMMENDATIONS
1. Adult dosing (≥ 18 years): Darunavir 600 mg twice daily + Ritonavir 100 mg
twice daily
2. Adolescent and pediatric dosing (< 18 years): as per dosing chart below
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C. SPECIAL INSTRUCTIONS
" Co-administer with ritonavir and food to enhance Darunavir plasma levels and
efficacy
" Tablets should be swallowed whole with a drink (e.g. water or milk)
" Consider oral suspension if patient is unable to reliably swallow tablets whole
" Close monitoring of weight required during dosing to prevent under dosing or
over dosing
" Dose should not exceed the recommended adult dose
" Oral suspension should not be frozen or refrigerated and should be stored in
original container
" Renal dose adjustments: No adjustment recommended in moderate renal
dysfunction. Consult if severe or end-stage renal dysfunction
" Liver dose adjustments: No adjustment recommended in mild to moderate
liver dysfunction. Not recommended in severe liver dysfunction
Consult senior clinician or National HIV Clinical Support Center if any concerns
about adverse drug reactions.
F. DRUG INTERACTIONS
44!
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Note: For more information on drug interactions, visit online resources such as;
www.medscape.com/drug-interactions or www.drugs.com/drug-interactions.
ETRAVIRINE&(NonINucleoside&Reverse&Transcriptase&Inhibitor)&&
A. DOSAGE FORMS, STRENGTH AND PACKAGING
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increased Creatinine
" Rare: Anemia, diabetes, hepatic failure, toxic rash/SJS
E. MANAGEMENT OF ADVERSE DRUG REACTIONS
Consult senior clinician or National HIV Clinical Support Center if any concerns
about adverse drug reactions.
F. DRUG INTERACTIONS
Note: For more information on drug interactions, visit online resources such as;
www.medscape.com/drug-interactions or www.drugs.com/drug-interactions.
46!
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Medication&Use&Counseling&(MUC)&
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MUC!refers!to!counseling!offered!by!pharmacists!and!other!health!professionals!at!
the!dispensing!point!regarding!use!of!medicinal!products.!It!is!recommended!for!all!
patients!initiating!antiretroviral!therapy!(ART)!and/or!switching!ART!regimens.!
MUC!is!essential!in!order!to:!
• Educate!patient!&!promote!adherence!!
• Improve!patient’!s!confidence!in!the!health!care!system!
• Assess!patient’s!understanding!of!their!treatment!!
• Get!feedback!from!the!patient!
(For.more.information,.refer.to.the.National.Integrated.HIV.Training.
Curriculum.(NHITC),.Module.23Y.Pharmaceutical.CareYsection.on.MUC).
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Pharmacovigilance&
• Health!professionals!should!actively!look!for!adverse!drug!reactions!(ADRs)!
• Any!suspected!ADR!to!be!reported!to!PPB!(can!be!done!electronically)!!
• Facilities!should!conduct!monthly!reviews!of!all!reported!ADRs!and!discuss!
in!Multidisciplinary!Teams!(MDTs)!and!Medicines!and!Therapeutics!
Committees!(MTCs)!
• However,!it!is!worth!noting!that!ADRs!are!not!easy!to!identify,!as!some!may!
mimic!new!illnesses!e.g.!an!opportunistic!infection!or!co`morbidity!
• Good!clinical!practice!is!therefore!important!for!identification!and!
management!of!ADRs!
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(For.more.information,.refer.to.the.NHITC,.module.23Y.Pharmaceutical.care.–.
section.on.pharmacovigilance)..
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Ministry of Health
National AIDS and STI Control Programme
Third Line ART Reporting Form
Patient clinic number: Sex: O Male O Female Weight (kg): Height (cm):
Medications & Adherence
Date initiated on third line regimen (first report only): _____/______/_________DD/MM/YYYY
Any suspected side effects/toxicities related to third line ARVs? O Yes (specify):___________________________ O No
Sources of adherence support (tick all that apply): Treatment buddy Support group (actively attending)
Peer supporter (DOT) Relative (DOT) CHW/CHEW (DOT) Other DOT, specify: ________________
Home visit in past 3 months SMS reminders Other, specify: ____________________
Lab Results within past 3 months Sample Draw Date (DD/MM/YYYY) Value
Viral load
Creatinine
ALT
HB
Blood sugar
Total cholesterol
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List&of&Contributors&
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Dr.!Irene!Mukui!NASCOP!
Dr.!Shobha!Vakil!NASCOP!
Dr.!Evans!Imbuki!NASCOP!
Dr.!Susan!Njogo!NASCOP!
Dr.!Caroline!Olwande!NASCOP!
Dr.!Linda!Misiko!NASCOP!
Dr.!Laura!Oyiengo!NASCOP!
Patricia!Macharia!NASCOP!
Lenet!Bundi!NASCOP!
Mohamud!Mohammed!NASCOP!
Dr.!Sarah!Masyuko!NASCOP!
Dr.!Maureen!Kimani!NASCOP!
Prof.!Jeremy!Penner!UCSF!
Dr.!Reson!Marima!UMB!
Dr.!Michelle!Ogolla!LVCT!
Dr.!Angela!Mcligeyo!CHS!
Dr.!Alexandra!Vandenbulcke!MSF`!France!
Dr.!David!Bukusi!K.N.H!
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Copyright.Statement.
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This!Toolkit!is!under!copyright!of!the!National!AIDS!and!STI!Control!Programme!
(NASCOP),!Ministry!of!Health,!Kenya.!
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All!reasonable!precautions!have!been!taken!by!NASCOP!to!verify!the!information!in!
this!publication.!
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For!clarifications!and!enquiries!please!contact:!
National!AIDS!and!STI!Control!Programme!(NASCOP)!
P.O.!Box!19361,!Nairobi,!Kenya!
Tel:!254!20!2729502,!2714972!
Email:!info@nascop.or.ke!
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