A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia
Phase: NA
Conditions: HIV Infections
Sponsor: HIV Prevention Trials Network

"A Comparison of Different Community Models of 
ART Delivery Amongst Stable HIV+ Patients in two 
Urban Settings in Zambia" 
(DAIDS-ES ID: 38191) 
A sub-study of 
HPTN 071: Population Effects of Antiretroviral Therapy to Reduce HIV Transmission 
(PopART): A cluster-randomized trial of the impact of a combination prevention package on 
population-level HIV incidence in Zambia and South Africa (DAIDS ID: 11865) 
A Non-IND Study of the HIV Prevention Trials Network 
Sponsored by: 
Division of AIDS, U.S. National Institute of Allergy and Infectious Diseases 
U.S. National Institutes of Health 
Protocol Chair: 
Mohammed Limbada 
Final Version 1.0 
10 January 2017 

TABLE OF CONTENTS 
TABLE OF CONTENTS ......................................................................................................................... 2 
PROTOCOL TEAM ROSTER ................................................................................................................ 3 
OVERVIEW OF THE STUDY DESIGN AND RANDOMIZATION SCHEME •••••..•..•.••••••••.••••••••••••••••••••••••••• 7 
1.0 
BACKGROUND ..•••...•••.•••••••••••..•••.•.••.•••••••••.••••••••••••••••••••••••••••••....•....••.•••••••••••••••••.••••••••••••••• 8 
1.1 LITERATURE REVIEW ................................................................................................................. 10 
1.2 STUDY JUSTIFICATION ......••..••••.•.•.......••.••••••••••.••.•.•••••••••••••••...••.........•..••••••••••••••••••••••••••••••••••• 13 
2.0 
STUDY OBJECTIVES AND STRATEGY •••.••.••.••.....•.•.•••.••..•••••••........•••.••••••••••••••••••••••••••••••••••••• 15 
2.1 
HYPOTHESIS ................................................................................................................................ 15 
2.2 
PRIMARY OBJECTIVE .................................................................................................................... 15 
2.2.1 SECONDARY OBJECTIVES .............................................................................................................. 15 
3.0 METHODS •.••.••..••..••••.••••.•••••..•••••..........•.••••••••••••••••.••••••••••••••.••••.•.•....•.•.••••••••••••••••••••••••••••••••• 16 
3.1 
STUDY DESIGN AND SETIING .......................................................................................................... 16 
3.1.1 STUDY POPULATION ..................................................................................................................... 17 
3.1.2 INTERVENTIONS ........................................................................................................................... 17 
CLINICAL MANAGEMENT OF CLIENTS IN BOTH MODELS OF CARE ............................................. 22 
3.1.3 INCLUSION CRITERIA ..................................................................................................................... 23 
3.1.4 RANDOMIZATION ......................................................................................................................... 23 
3.1.5 STUDY PROCEDURES ..................................................................................................................... 24 
4.0 STUDY OUTCOMES .................................................................................................................... 24 
5.0 DATA COLLECTION AND TOOLS ................................................................................................. 25 
6.0 PROCESS EVALUATION .............................................................................................................. 29 
7 .0 STATISTICAL ANALYSIS .............................................................................................................. 29 
8.0 ETHICAL CONSIDERATION •...•....••••.•..........••..•••.•••.••.•..••••••.••••.••••..•.......•••••••••••••••••••••••••••••••••••• 31 
8.1 ETHICAL REVIEW ............................................................................................................................. 31 
8.2 PARTICIPANT WITHDRAWAL .............................................................................................................. 31 
8.3 ANTICIPATED RISKS ......................................................................................................................... 31 
8.4 BENEFITS TO THE STUDY PARTICIPANTS .............................................................................................. 32 
8.5 DISSEMINATION OF RESEARCH FINDINGS AND FINAL REPORT .................................................................. 32 
9.0 ADMINISTRATIVE PROCEDURES ................................................................................................ 32 
10.0 BUDGET ................................................................................................................................... 33 
11. STUDY TIMELINE ••••.••••..••.••..••...••..••.••••••.........•••••••••.•••.••.......••.••..••••.•.••••.•...•••••••••••••••.••••..•••••• 33 
12. REFERENCES ••••.••..................••.••.......••••••..•..•••.•.......••••••..••.•••..•••••••••••••••..•.•••.....•..••••••••••.••••.•••• 34 
COMMUNITY ART PROTOCOL V. 1.0 
10 JANUARY 2017 
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PROTOCOL TEAM ROSTER 
Mohammed Limbada 
Clinical Scientist/ Principal Investigator 
Zambart 
University of Zambia 
School of medicine, Ridgeway Campus, 
P.O. Box 50697 
Lusaka, Zambia 
Phone: +260 211 254710 / 0977770836 
Em ai I: rngJ:ic:imr:rn~.9@?J~.m b.?.r.t,Q.rg.:.?:.r!l 
Helen Ayles {Co-Pl) 
Clinical Scientist /Site Principal Investigator {HPTN 
071} 
Zambart 
University of Zambia 
School of Medicine, Ridgeway Campus 
Lusaka, Zambia 
Phone:+26021125471~ 
Email: Helen@zambart.org.zm 
Richard Hayes 
Protocol chair- HPTN 071 
Department of Infectious Diseases 
Epidemiology 
London School of Hygiene & Tropical Medicine 
Keppel Street 
London WClE 7HT, UK 
Phone: +44 0 20 7927 2243 
Email: richard.hayes@lshtm.ac.uk 
Sarah Fidler 
Protocol co-chair - HPTN 071 
Imperial College London 
CSL in Communicable Diseases 
St. Mary Campus 
HIV clinical Trials Unit 
Winston Churchill Wing 
London W2 lNY, UK 
Phone: +44 0 203 312 6790 
Email: s.fidler@imperial.ac.uk 
Kwame Shanaube 
PopART Study Manager-Zambia 
Zambart 
University of Zambia 
School of Medicine, Ridgeway Campus 
Lusaka, Zambia 
Phone: +260 211 254710 
Email: Kshanaube@zambart.org.zm 
COMMUNITY ART PROTOCOL V. 1.0 
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David Burns, M.D., M.P.H. 
DAIDS Medical Officer 
5601 Fishers Lane 
8B40 
Rockville, MD 20852 
Phone: 1-301-435-8896 
Email: burnsda@niaid.nih.gov 
Ab Schaap 
Senior Data Manager 
Zambart 
University of Zambia 
School of Medicine, Ridgeway Campus 
Lusaka, Zambia 
Phone: +260 211 254710, 
Email: ab@zambart.org.zm 
Musonda Simwinga 
Social Scientist/Community Coordinator 
ZAM BART 
University of Zambia 
School of Medicine, Ridgeway Campus 
P.O. Box 50697 
Lusaka, Zambia 
Phone: +260 211 254710, 260 211257215 
Fax: +260 211 254710 
Email: Musonda@zambart.org.zm 
Dr Crispin Moyo 
Clinical Care Specialist 
Ministry of Health 
P.O. Box 30205 
Ndeke House 
Haile Selassie Avenue 
Lusaka, Zambia 
Tel: +260 211 253 040 Ext: 1076 
Mobile: +260 977 816 438 
Email: crispin.moyo@moh.gov.zm, 
crispinmoyo@gmail.com 
Sian Floyd 
Statistician 
Department of Infectious Disease Epidemiology 
London School of Hygiene & Tropical Medicine 
Keppel Street 
London, WClE 7HT, UK 
Phone: +44-207-6127888 
Fax: +44-207-6368739 
Email: sian.floyd@lshtm.ac.uk 
3 

Sam Griffith 
Senior Clinical Research Manager 
FHl360 
359 Blackwell Street, Suite 200 
Durham NC 27701, USA 
Phone: +001-919-544-7040 ext. 11571 
Email: sgriffith@fhi360.org 
Virginia Bond 
Social Scientist 
London School of Hygiene & Tropical Medicine 
ZAM BART Project, School of Medicine 
P.O. Box 50697 
Lusaka, Zambia 
Phone:+260211254710 
Email: gbond@zambart.org.zm 
Mr. Lawrence Mwenge 
Health Economist 
Zambart 
University of Zambia 
School of Medicine, Ridgeway Campus 
P.O. Box 50697 
Lusaka, Zambia 
Phone: +260 211 254710, 
Email: .'=.awr.~ce@.zq.r.:n!?_art.ocg,J_m 
COMMUNITY ART PROTOCOL V. 1.0 
10 JANUARY 2017 
Dr. Wilbroad Mutale 
Lecturer 
University of Zambia 
School of Medicine, Ridgeway Campus 
Lusaka, Zambia 
Email: wmutale@yahoo.com 
James Mwanza 
Clinical Pharmacist 
Zambart 
University of Zambia 
School of Medicine, Ridgeway Campus 
P.O. Box 50697 
Lusaka, Zambia 
Phone: +260 211 254710, 
Email: james@zambart.org.zm 
Noah Mtonga 
Pharmacist 
Zambart 
University of Zambia 
School of Medicine, Ridgeway Campus 
P.O. Box 50697 
Lusaka, Zambia 
Phone: +260 211 254710 
Email: noah@zambart.org.zm 
4 

PROTOCOL SUMMARY 
Purpose: The purpose of this study is to compare the virological and clinical outcomes of patients 
participating in community models of ART delivery to the standard of care in an urban setting in 
Zambia. 
Design: A three-arm cluster-randomized non-inferiority trial to be implemented in two urban 
communities. Randomization will be at the level of community health worker (CHiP), stratified by 
community 
Study population: A prospective cohort of adult patients enrolled into ART care in two urban 
communities participating in the HPTN 071 (PopART) trial. The intervention packages will be 
implemented throughout the two communities. 
Study Size: Intervention will be implemented in 2 communities (Chipata and Kanyama), which have a 
total of 104 community health worker (CHiP) zones. Within each community, the CHiP zones will be 
randomized to one of the 3 trial arms. In the community with 54 zones, 18 zones will be randomized 
to each of the 3 trial arms. In the community with 50 zones, 17 zones will be randomized to the two 
11intervention" arms and 16 zones will be randomized to the 11standard-of-care" arm. 
Based on data from the first annual round of the CHiP intervention, the number of adults who are 
known by the CHiP teams to be HIV-positive and to be taking ART at the time of the most recent CHiP 
follow-up visit averages 50 per zone, with a harmonic mean of 36 per zone. Assuming that 80% of such 
adults agree to participate in the study and have not moved out of the community within 12 months 
after enrolment, the number of study participants per zone who can contribute to the primary 
endpoint measurement will have a harmonic mean of 30. 
Study Arms/Interventions: 
Arm 1: Adherence Clubs 
• 
Patients living in these zones will be offered the choice of either being part of an 
adherence club or to continue receiving care at the clinic. In this model, adherence clubs 
will consist of a group of 20-25 stable patients who receive care in the community. 
Members of the club will meet every 3 months at an agreed communal venue where 
they will receive adherence support, symptom screening and pre-packed medications. 
Club members will be required two have 2 clinical visits (every 6 months) in a year for 
their routine clinical review and laboratory monitoring. 
Arm 2: Home-Based ART delivery 
• 
Patients living in these zones will be offered the choice of home ART delivery by the CHiP 
or to continue receiving care at the clinic. This model will provide ART to clinically stable 
patients in their homes. The CHiPs will visit the participant's homes once every 3 months 
to provide adherence support, symptom screening and dispense pre-packed drugs to the 
participant. The participant will only be required to visit the clinic twice in a year for 
routine clinical review and laboratory monitoring. 
Arm 3: Control Arm 
• 
Patients will continue receiving care at the local clinic. 
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Study Duration: The planned duration of the entire study will be approximately 24 months after 
implementation of the models. Assessment of the primary outcome is planned to be collected at 12 
and 24 months after recruitment whereas secondary outcomes are planned to be collected at 6, 12 
and 24 months after recruitment. 
Primary Objective: To compare virological suppression at 12 months in HIV+ patients receiving care 
via community ART models with those receiving care in the clinic (standard of care). 
Secondary Objectives: 
1. To compare the proportion of patients with virological suppression at 24 months in patients 
receiving care via community ART models with those receiving care in the clinic (standard of care). 
2. To compare Loss to Fo!!ow-up (LTFU) rates and missed dispensation of ARVs among individuals 
receiving care via community ART models with those receiving care in the clinic (standard of care)., 
measured using routine health centre data 
3.To compare HIV disease progression, and death among individuals receiving care via community ART 
models with those receiving care in the clinic (standard of care), measured using: 
• 
CD4 cell count, WHO staging events, death from routine health centre data. 
4. To qualitatively assess how health staff (including CHiPs) and PLWH on treatment experience the 
two models of ca;e. This would be achieved through: 
• 
Documenting treatment, adherence and retention experiences of PLWH accessing treatment 
through adherence club and home delivery models; 
• 
Exploring the impact of the two models of care on access to treatment, adherence and 
retention according to the experience and perspectives of CHiPs and health facility staff; 
• 
Qualitatively comparing how participant (PLWH and health staff) experience the models of 
care and experiences with the routine standard of care at the local health facilities; 
• 
Qualitatively assessing participant (PLWH and health staff) perceptions about and experiences 
with the impact of the models of care on HIV services at the local health facilities. 
5. To measure the health system costs of delivering the different community ART models 
Study Sites: This study will be implemented in two Lusaka communities - Chipata and Kanya ma. 
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OVERVIEW OF THE STUDY DESIGN AND RANDOMIZATION SCHEME 
11 Stable Adult patients (lJJl years) 
Community 1 
54 CHiP Zones 
Arm 1 (35 Zones) 
Community Adherence Clubs 
Group of 20-25 HIV+ patients 
3-monthly club meeting~ 
CHiP team conducts adherence 
support, symptom screening and 
dispense pre-packed medications 
2 clinic visits every year for clinical 
review and laboratory monitoring 
Evaluation 
Data collected during club sessions 
Routinely- collected data from health 
centre 
EUG!B!UJY CRITEft!A 
Community 2 
50 CHiP Zones 
Randomization 
Arm 2 (35 Zones) 
Home-Based ART Delivery 
Clients visited in their homes every 
3 months by the CHiP 
CHiP team conducts adherence 
support, symptom screening and 
dispense pre-packed medications 
• 
2 clinic visits every year for clinical 
review and laboratory monitoring 
Evaluation 
Data collected during home visits 
• 
Routinely- collected data from 
health centre 
Primary Outcome Measure 
Arm 3 (34 Zones) 
Standard of Care 
• 
Control arm 
Evaluation 
Routinely-collected data from the 
health centre 
• 
Virologlcal suppression at 12 months in patients receiving care via community ART models with those 
receiVlng care in the clinic 
Secondary Outcome Measures 
• 
Viral suppression at 24 months 
• 
Retention in care/Loss to Follow-up at 6, 12 and 24 months 
• 
HIV disease progression 
• 
Death 
• 
Participant choice of model and retention within that model 
• 
Drug supplies in the models of care 
• 
Qualitative evaluation of the acceptability and functioning of the two models of care 
• 
Economic analysis to measure the economic costs of the intervention 

1.0 
Background 
By the end of 2013, 12.9 million people living with HIV were receiving antiretroviral therapy (ART) 
globally, representing 37% of those in need. This is a significant improvement from 10% in 2006 (1). 
The majority of these individuals in resource poor settings receive their ART from primary health care 
facilities which have done an incredible job in scaling up treatment of HIV infected individuals in the 
last decade, however, the growing cohort of HIV infected individuals needing ART poses a significant 
challenge to often fragile health services (2). 
In Zambia, 13.3% of adults aged 15-49 years are infected with HIV (11.3% among adult males, 15.1% 
females). The HIV prevalence is highest in urban settings (18.2%) and lowest in rural settings (9.1%)(3). 
Significant progress has been made over the last decade in increasing and improving access to and the 
use of HIV treatment services. Implementation of the 2013 WHO Consolidated Treatment guidelines 
which increased the eligibility criteria for ART initiation and option B+ resulted in more individuals 
accessing ART services. In 2014, a total of 671,066 adults and children (267, 092 males and 403,974 
female) were receiving antiretroviral therapy. Of these, 108,334 were newly initaited in 2014 alone. 
625, 546 were adults 15 years and above, exceeding the national target of 569,567. In the same year 
45,520 children were receiving ART exceeding the target of 42,115(4). 
The recent introduction the 2015 World Health organization (WHO) guidelines recommend ART 
initiation to all adults irrespective of WHO clinical staging and CD4 threshold(5) means that even more 
individuals are eligible for ART. Adherence to treatment and virological suppression will be critical 
factors for survival and prevention of onward transmission and without a change in the current 
delivery model of ART in countries such as Zambia; lifelong ART for all PLHIV is unsustainable. 
Overcrowding of health facilities and overburdening of the health systems may lead to interruptions 
of therapy and incomplete adherence leading to increased mortality, on-going transmission and 
development of drug resistance(6). Models for dec:entralizing ART services through community ART 
delivery may be important and innovative strategies for maintaining the continuum of care as we 
strive towards universal treatment to meet the ambitious joint United Nations Program on HIV/AIDS 
(UNAIDS) 90-90-90 targets by 2020. 
Fig 1: Number of Children and Adults recieving ART 2010-2014 in Zarn bi a 
700,000 
600,000 
500,000 
400,000 
300,000 I 
200,000 
100,000 
0 
2010 
• Adults 
319,019 
• Children 
25,388 
Ulf•/llvillt·.JllY i\1\1 l'l:tJJ()( UI \I i ,t) 
I I I )/\ l•Jl Ii\!\ Y >11 I / 
2011 
2012 
385,498 
446,841 
30,187 
34,084 
2013 
530, 702 
49,41 5 
2014 
625,546 
45,520 
Source: GARPR Zambia Country Report 
8 

The fragile health systems, as is the case in most sub-African countries, the human resource crisis is 
the result of many macroeconomic and governance factors. The crisis is further compounded by the 
impact of the HIV/AIDS pandemic. The human resource crisis is multifactorial but reasons include 
excessive workload and burnout, high attrition rates of trained professionals; difficult working 
conditions and poor salaries; low motivation and high burden of infectious diseases, particularly 
HIV/AIDS, among the workforce. The scale up of ART services and move towards universal test and 
treat in sub-Saharan Africa has highlighted the human resource challenge on the existing fragile 
human resource base (7-9). The World Health Organization (WHO) estimates that there is a global 
deficit of more than 4 million trained health workers and these shortages are critical mostly in sub-
Saharan African Countries and parts of Asia. In European countries, there were nearly two doctors per 
person living with HIV/AIDS as compared to low resource settings where an average of 2000 HIV/AIDS 
infected individuals per doctor(lO). 
Fig 2: Number of Doctors, Nurses and People living with HIV/ AIDS in Selected Countries 
Country 
Doctors per 
Nurses per 
People living 
People living 
People living 
100,000 
100,000 
with 
with 
with 
Population 
population 
HIV/AIPS 
HIV/AIDS per 
HIV/AIDS per 
Doctor 
Nurse 
Malawi 
1 
26 
900,000 
7435 
286 
Zambia 
7 
113 
920,000 
1216 
75 
Zimbabwe 
6 
54 
1800,000 
2337 
260 
South Africa 
69 
388 
5300,000 
171 
30 
Cambodia 
16 
61 
170,000 
75 
20 
Brazil 
206 
52 
660,000 
2 
7 
USA 
256 
937 
477,000 
0.6 
0.1 
United 
230 
1212 
83,000 
0.6 
0.1 
Kingdom 
Source: N EngiJ Med 2007 
Despite significant progress in scaling up ART, Zambia faces significant shortages of HCWs with staffing 
deficits estimated at over 70% for doctors, clinical officers and nurses(ll, 12). The World Health 
organization /Ministry of Health establishment recommends a staff to population ratio of 1:1500, 
1:1700, and 1:8000 for doctors, nurses and pharmacists, respectively. The existing human resource 
capacity in Zambia is below the recommended cadre-to-population ratios with existing levels of 
1:17589, 1:8064 and 1:473 450 for doctors, nurses and pharmacists respectively(7).ln trying to cope 
with demand, there has been decentralization of ART services from hospitals to primary health care 
facilities and task shifting from doctors to nurses and community health workers (CHWs)(13). A 
number of ART programs have already begun re-assigning tasks as a result of shortages in specific 
classes of personnel, such as using nurses to evaluate patients for ART and prescribe for 
uncomplicated patients and shifting counselling and education to lay counsellors as a way of stretching 
the resources. As we move towards the 2015 WHO universal test and treat guidelines, HIV programs 
COMMUNITY ART PROTOCOL V. 1.0 
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will increase and to avoid overwhelming the entire health system, innovative ART care delivery models 
need to be considered.(7} 
The 2015 WHO guidelines recommends that provision of ART services can be maintained in the 
community, but operational guidance and further evidence is needed for this to happen in practice. 
Decentralizing ART services into the communities may ease the burden of routine management on 
other parts of the health systems and improve equity by promoting access to ART in rural and urban 
areas. In low resource settings with a high burden of HIV, transport cost to the health facilities and 
long waiting times for patients are significant barriers to access and retention in care. Thus 
decentralizing of ART care could reduce the workload for the health care workers, thereby reducing 
waiting times, strengthen community engagement and optimizing access to services and retention in 
care(14). On the other hand, the risks of decentralizing ART services include supply chain weaknesses 
resulting in ART stock outs, pilfering of drugs, inequity towards patients not involved in community 
ART delivery, patients in community based models not viewed as the responsibility of the health 
system, timely referral of complicated patients to the facility and risk of treatment failure despite lack 
of clinical symptoms(15, 16). 
Community based delivery of HIV care is one example of decentralizing HIV services from the health 
facilities to the community. This reduces the distance for patients to have to travel to access care and 
aiso supports retention in care (15, 16). it is designed to make ART more efficient for heaith systems 
and provide appropriate support to encourage !ong-term patient retention. !\1odels of community-
based delivery of ART have been developed in various settings and hold the promise of improving the 
continuum of care by decongesting the clinics and reduce the burden on healthcare workers. These 
models of care aim to make it easier for patients to access care and adhere to long term ART, however, 
further research is needed to evaluate them to ensure that outcomes are equivalent such as how to 
support long term retention in care while expanding ART provision, patients are virologically 
suppressed and logistics surrounding these models are not weakened by drug pilfering etc. 
1.1 Literature Review 
The scale-up of ART services has been rapidly implemented as a life- saving public health intervention 
and has resulted in averting an estimated 4.2 million deaths(17}. Since 2013, evidence and 
programmatic experience have continued to favour earlier ART initiation among adults living with HIV 
regardless of WHO clinical stage or at any CD4 cell count. There has been increasing evidence from 
systemic reviews and cohort analysis indicating that initiating ART earlier reduces mortality, morbidity 
and HIV transmission outcomes. Recent evidence from the HIV Prevention Trial Network 052, a large 
randomized clinical trial also demonstrated that early HIV treatment reduced the risk of HIV 
transmission by 96% (18, 19). 
Several studies have shown the potential for ART to prevent transmission of HIV by suppression of 
community viral loads (20, 21). Data from pilot projects suggest that universal test and treat has the 
potential to suppress community viral load resulting in reduction of HIV incidence(22) but this has yet 
to be confirmed in a well conducted randomised experiment. The World Health Organization (WHO) 
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recommendations on the use of ARVs has recently been revised in favour of immediate treatment 
regardless of CD4 count and clinical staging due to benefit to the patient(5). In addition, the Strategic 
Timing of Antiretroviral Treatment (START) study provided concrete scientific evidence that 
immediate initiation of ART in patients with HIV infection regardless of CD4 count reduced the risk of 
a combination of AIDS-related illness and death by more than half compared to deferring treatment. 
These results align benefits for individual patients with the public health benefit of antiretroviral 
therapy in reducing the risk of viral transmission and thus reinforce the need for universal test and 
treatment(23 ). 
All benefits from ART are dependent on patients being retained in care and adherent to treatment. As 
national ART programs move towards these recommendations, it will be crucial to ensure that loss-
to-follow up (LTFU) is reduced and retention in care is improved. Systemic reviews from sub-Saharan 
Africa estimate that approximately(18) a third of patients are lost to follow up in ART programs within 
the first two years on treatment(24-26). In the same region, retention in care was estimated at 79%, 
75% and 62% at 6, 12, and 24 months respectively(24). An updated review in 2010 in a cohort of more 
than 200,000 patients, the program retention was 86%, 80%, 77% and 72% at 6, 12, 24 and 36 months 
respectively(25, 27). Therefore, the key challenges that national programs will face in the expansion 
of ART services will no longer be the access to services but ensuring that patients are not loss to follow-
up and retention is improved. 
Over the last few years, there have been many interventions suggested to improve LTFU and retention 
and these include task shifting and decentralization of ART services. Models of care for ART delivery 
have considerably evolved in resource limited settings. Services have been decentralized from 
hospitals to primary care facilities and recently into the communities. Community-based models of 
ART delivery offer a further level of decentralization, which includes shifting of tasks to the community 
health workers (CHW) and the patient themselves. These models of care are directed towards stable 
adult patients. While there is no agreed definition of "stable" in this context, patients generally are 
considered stable if they have been taking ART successfully from a minimum period of time, have no 
concurrent illness, have a degree of immune recovery (or are virologically suppressed), and are able 
to adhere to ART(28). These models allow patients to receive care within the communities by allowing 
community health workers to provide on-going adherence support and dispensation of pre-packed 
medications thus reducing the frequency of clinic visits. Patients were only expected to go to the clinic 
twice annually for their routine clinical review and laboratory monitoring. In these models, patients 
were initiated on ART at the facility and once stable are down referred to models of care. The health 
facilities and hospital services served as back-up for complicated clinical care needs (44, 45). 
Several studies have assessed the feasibility of community models of ART delivery in sub-Saharan 
Africa where the health facilities serve as referral sites (Table 1). A recent Cochrane review of 
decentralization included two studies of community ART delivery, one in Uganda and one in Kenya, 
which provided home-based ART delivery and reported favourable outcomes compared to facility-
based models(29-37). In Uganda, a cluster-randomized controlled trial in Jinja evaluated the impact of 
home-based ART delivery and facility based care where the primary endpoint was virologic failure over 
3 years of follow-up(32). ART was initiated in the facility and community health care workers 
conducted monthly visits to patient's homes where symptom screening for toxicity and disease 
progression, adherence support and ART delivery was done. After 12 months on therapy, no 
difference in the mortality, LTFU and virologic failure was observed between the two models of care. 
Kipp et al. assessed the effectiveness of rural community-based ART program in Uganda and compared 
the treatment outcomes and mortality with a well-established hospital based program(38). In this 
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model of care, community health workers conducted weekly visits to patient's homes and provided 
ART and adherence support. After 2 years, all- cause mortality was similar in both cohorts but 
community based model patients were twice more likely to achieve viral suppression and good 
adherence to treatment(39). A similar study in Kenya, where stable patients were randomized to 
either receive standard of care within the clinic or a model where CHW provided home -based ART 
delivery, shovved that community-based care by PL'vVH resulted in similar outcomes as standard of 
care but with half the number of clinic visits suggesting that task shifting into the community can 
deliver safe and effective community based care, expediting ART roll-out and increasing access to 
treatment in resource limited settings(35, 40). 
Other models of care have also been recently piloted in sub-Saharan Africa as a way to decentralize 
HIV care into the communities. These include: 
1. Adherence clubs 
In this approach, a group of clinically stable patients meet once every 2 or 3 months at a health facility 
or a community venue. This model allows for peer support and health education among its members. 
Essential tasks such as weighing patients, symptom screening, adherence support and pre-packed ART 
distribution are carried out by a peer educator and/or lay counsellor who acts as a club facilitator. This 
enables patients to visit the clinic once or twice a year for their clinical consultation and routine 
laboratory monitoring. Patients reporting symptoms or found to be missing their club appointments 
are referred back to the clinic for assessment. This model is well adapted in urban settings where time 
spent at the clinic is an issue for patients {41, 42). Adherence clubs were piloted in Khayelitsha, South 
Africa in 2007 as a way to decongest the clinics. These clubs comprised of approximately 30 stable 
patients and met every second month with a CHW or a nurse for the club session. Data from this pilot 
showed that 97% of patients were retained in care and the risk of LTFU was reduced to 57% (43, 44). 
Since 2012, Medicines' Sans Frontiers' (MSF) piloted an extension of this model into the community 
and by 2013, have collaborated with the Provincial Government of the Western Cape in implementing 
776 adherence clubs representing 19% of all ART patients in care in the metropolitan area(42). The 
implementation of these community-based adherence clubs (CACs) at a large, public sector facility in 
peri-urban Cape Town had more than 2000 stable patients down referred from primary health care 
facilities to CACs and overall retention was 97% at 6 months and 94% at 12 months (46). These findings 
support the continued expansion of community-based models of ART delivery in high prevalence 
resource settings. 
2. Community ART Groups {CAGs) 
In this model, stable patients organize themselves into a group of six, taking turns to collect ARVs 
every month for each of the group members. The group members attend the facility every month to 
pick up ART for the whole group and dispense drugs to other members in a patient's home. Whilst the 
group member picks up the drugs for the group, s/he also gets his 6 monthly or yearly clinic 
consultation and routine laboratory tests. This model was found to be well adapted in rural settings 
where distance to the clinics are the major barrier and where there is a tight sense of 
community(2).CAGs were piloted in the Tete province in Mozambique since 2008. Results from this 
pilot study found high levels of acceptance among patients as CAGs reduced the cost and time burden 
on patients and strengthened adherence support(42). This modei showed low rates of LTFU and 
COMMUNITY ART PROTOCOL V. 1.0 
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12 

retention rates among the CAG members were 98%, 96% and 93% after 12,24 and 36 months on 
ART(45, 46). The results of this pilot model enabled the CAG model to be incorporated into the 
National HIV care strategy of Mozambique and by the end of 2013, more than 17,000 patients were 
receiving ART in a CAG (42). 
Table 1. Publications on community models of care 
Publication 
Location 
Study design'& Objective 
Findings 
Jaffar 2009 
Uganda 
Cluster RCT comparing home-based ART to 
No difference in 
facility based care 
mortality after 12 
months or virological 
failure (1% vs 2%) 
between the two. 
Kipp2012 
Uganda 
Prospective cohort study assessing the 
There was no difference 
effectiveness of rural HC/community -
in viral suppression at 6 
based ART program and compare the 
months (90% vs. 89%) or 
treatment outcome (VL)of home based ART 
mortality in the home-
to hospital-based ART 
based vs. hospital based 
cohorts 
Se/ke2010 
Kenya 
Prospective cluster RCCT comparing the 
Clinical outcomes were 
outcomes of stable patients managed by 
similar 
as 
that 
of 
CHWs in home-based care vs. clinic based 
standard of care but with 
care 
half the number of clinic 
visit. 
Luque-Fernandez 2013 
South Africa 
Cohort study to evaluate the effectiveness 
After 18 months, 97% of 
of adherence clubs compared to clinic 
club patients remained in 
based care in maintaining or improving 
care compared to 85% in 
retention 
the 
clinic. 
LTFU 
was 
reduced by 57% [ HR 
0.43] 
Decroo 2014 
Mozambique 
Outcomes of Community Adherence Group 
98% retention at 12, 24 
(CAG) patients 
months. 
Humpreys 2010 
Swaziland 
prospective 
cohort 
to 
compare 
the 
No differences in LTFU 
outcomes of stable patients referred to CHC 
noted 
A systemic review and meta-analysis of literature to assess the effect of home-based interventions on 
virologic outcomes in adults receiving ART in Africa showed insufficient data to know whether there 
is a difference in virological suppression at 12 months in home-based interventions as compared with 
the standard of care. Given the few trials conducted in Africa, there is need for further research that 
measures the effects of home-based models on virological suppression in African populations(47). 
1.2 Study Justification 
Although community-based models of ART delivery have shown promising outcomes in relation to 
retention in care and adherence to treatment, (48) additional data is required from innovative 
community-based models of care to support long term retention as ART cohorts in resource limited 
settings continue to expand in the context of universal test and treatment. The lessons learnt will be 
needed to improve the efficacy and effectiveness of the HIV continuum of care and enable programs 
to redesign delivery systems and focus on less centralized treatment delivery points that often require 
\I 1.0 

patients to travel long distances to health centre and also allow decentralization of health systems to 
meet scale-up targets and sustain treatment gains. Studies show that ART can be delivered through 
different routes but there is a lack of evidence about which model provides the most cost-effective 
strategy and how this can be integrated into other community-based programmes. This study will nest 
the evaluation of 2 different models of community ART delivery into an on-going cluster-randomised 
trial. The HPTN 071 ( PopART) trial is currently evaluating the impact of community level combination 
prevention package, which includes universal HIV testing, active linkage to care and intensified 
provision of ART, on population level HIV incidence. This is a three-arm, cluster randomized, trial being 
implemented in 21 communities in of which 12 are in Zambia and 9 in South Africa. Arm A includes 
universal testing with immediate ART, Arm B includes universal testing with ART eligibility according 
to the current national guidelines and Arm C is the standard of care (control arm). 
Fig 2. Schematic Diagram of the HPTN 071 trial 
3 arm cluster-randomised trial with 21 communities 
(N = 1-2million total population) 
FWAPap~ 
Intervention 
lncladtr-11"= 
lrnmed'8te"AR.-r 1= 
1rrei11~a,ctlve of cg~ 
·~ 
count 
~" 
Arm B 
eJtcep 
ART Initiation 
according to current 
national gu ldellnes* 
Standard of care at 
current service 
provision levels 
Including 
ART Initiation 
according to current 
nation al gu idellnes* 
*orlginally CD4-coun~ <350 cells/mm 3 
These interventions are being delivered by Community HIV Providers (CHiPs). The CHiPs are members 
of the community, appointed to provide a package of basic services at a household level, particularly 
HIV counselling and testing and linkage to care for those who are HIV positive. Their responsibilities 
include conducting HIV counselling and testing, condom distribution, screening for TB and linking 
household members for appropriate HIV prevention, treatment and care services. This study will 
utilise these existing community health care providers to implement 2 models of community-ART 
delivery: 
1. 
CHiPs delivering ART packages to their clients on a regular basis 
2. 
CHiPs facilitating Community ART clubs 
It is not known whether these models of ART delivery will be feasible in urban low resource settings, 
or whether the care will be as good as the standard quality of care provided by the health systems, 
therefore this study is timely and innovative: 
(1). This will be a first study in an urban setting in Zambia to rigorously evaluate different models of 
community ART delivery. This information will be critical for the continued scale up of universal test 
and treatment and may have cost efficient synergies utilising community HIV test providers. 
( tilv1i'.'1lil•!llY 1\l\I l'l:111t lt IJI V l Ii 
111 i/\f 011 If\!(\' .'(JI f 
14 

(2). This study will be a randomized head to head non-inferiority comparison. To this date no studies 
have shown a comparison in clinical outcomes between the different Community ART models and 
between them and the current standard of care. 
(3). This study will provide policy makers with evidence on operational feasibility, acceptability and 
cost effectiveness of two models and guide policy on the best models to roll out in the context of un. 
The Zambian Ministry of Health has identified community models of ART delivery as a way of 
expanding treatment in the context of universal test and treat. The government, through the National 
AIDS Council, has engaged several in-country partners and researchers to pilot different community 
models of ART delivery in order to generate information required to inform model standardization at 
national level for wider roll-out. These models of care will only include stable adult ART patients, 
defined as patients on ART for more than 6 months who are virologically supressed. 
In addition to providing policy makers with evidence for community ART models, this study will also 
enhance the objectives of the HPTN071 trial where linkage to care and retention in care are essential 
for the outcome of the trial. This study will also increase local scientific capacity to conduct 
implementation research in order to sustain national ART and PEPFAR targets as well as build 
collaborations between indigenous Zambian non-profit organizations, the University of Zambia 
(UNZA) and Ministry of Health, drawing expertise that will ultimately strengthen Zambian research 
capabilities. 
2.0 
Study Objectives and Strategy 
2.1 
Hypothesis 
Overall clinical, immunological and virological outcomes in patients receiving care via community ART 
delivery models are not inferior to those receiving care in the clinic (standard of care) in urban poor 
resource settings. 
2.2 
Primary Objective 
To compare virological suppression at 12 months in HIV+ patients receiving care via community ART 
models with those receiving care in the clinic (standard of care). 
2.2.1 Secondary Objectives 
1. To compare the proportion of patients with virological suppression at 24 months in patients 
receiving care via community ART models with those receiving care in the clinic (standard of care). 
2. To compare Loss to Follow-up (LTFU) rates and missed dispensation of ARVs among individuals 
receiving care via community ART models with those receiving care in the clinic (standard of care)., 
measured using routine health centre data 
3.To compare HIV disease progression, and death among individuals receiving care via community ART 
models with those receiving care in the clinic (standard of care), measured using: 
o 
CD4 cell count, WHO staging events, death from routine health centre data. 
4. To qualitatively assess how health staff (including CHiPs) and PLWH on treatment experience the 
two models of care. This would be achieved through: 
• 
Documenting treatment, adherence and retention experiences of PLWH accessing treatment 
through adherence club and home delivery models; 
COMMUNITY ART PROTOCOL V. 1.0 
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15 

• 
Exploring the impact of the two models of care on access to treatment, adherence and 
retention according to the experience and perspectives of CHiPs and health facility staff; 
• 
Qualitatively comparing how participant (PLWH and health staff) experience the models of 
care and experiences with the routine standard of care at the local health facilities; 
• 
Qualitatively assessing participant (PLWH and health staff) perceptions about and experiences 
with the impact of the models of care on HIV services at the local health facilities. 
5. To measure the health system costs of delivering the different community ART models. 
In addition, we will measure the effect of the combined models on health facility crowding and 
waiting times as well as time to ART initiation of new patients in the 2 facilities (non- randomised 
comparison as both facilities have all models of care). 
3.0 Methods 
3.1 
Study Design and Setting 
The study will be a cluster-randomized non-inferiority trial in a prospective cohort of adults enrolled 
in to ART care at two urban primary health care facilities that serve two of the HPTN 071 trial 
communities in Lusaka, Zambia. These two communities include Chipata and Kanya ma, which are the 
Lusaka arms A and B communities of the parent trial (HPTN 071) respectively. The reason for 
conducting the study in these two communities is that they are located in an urban setting whe;e 
there is a high number of HiV patients in care, thus overburdening the clinics and an ideal setting to 
determine if these community models of ART delivery benefit t~e health care system in urban Zambia 
by decongesting clinics and making treatment easier to access. 
The HPTN 071 (PopART) trial is evaluating the impact of community level combination prevention 
package, which includes universal HIV testing, active linkage to care and intensified provision of ART, 
on population level HIV incidence. This is a three-arm cluster randomized trial being implemented in 
21 communities of which 12 are in Zambia and 9 in South Africa. These interventions are being 
delivered by Community HIV Providers (CHiPs) who are members of the community, appointed to 
provide a package of basic services at household level particularly HIV counselling and testing, linkage 
to care for those who are HIV infected, HIV /TB education, adherence support, distribution of condoms, 
screening household members for TB and STI and linking household members for appropriate HIV 
' 
prevention, treatment and care services. 
Before the start of the main trial, mapping of the households and non-residential buildings, with a 
census to count the number of adults (~ 16 years old) and children (:516 years old) was done and the 
map of the communities was created based on global positioning system (GPS) coordinates of all 
households and non-residential buildings. Following the mapping the data was used to define the 
catchment area of the clinic and to divide it into "CHiP zones" with one CHiP team being responsible 
for a zone. Each zone within these communities has approximately 400-450 households served by the 
CHiPs. Table 2 shows the number of CHiPs teams/zones in the 2 communities with the population 
each G:HiP teams covers and the number of HIV positive adults being cared for in each zone 
COMMUNITY ART PROTOCOL V. 1.0 
10 JANUARY 2017 
16 

Table 2: Total number of zones in the communities served by the CHiP teams 
Average per zone 
99.3 
Range in the zone 
33-234 
Min-max· 
56 
14-155 
51.3 
56.38 
18-143 
48- 213 
4-143 
46.7 
3-102 
Each zone is served by 2 CHiPs, therefore 1 CHiP will have an average of 23-25 clients on ART who may 
need to be provided with ART within the community. 
3.1.1 Study Population 
The eligible study population will include all stable HIV infected ad.ult patients(~ 18 years) on first-line 
ART residing in the 2 HPTN 071 communities and enrolled in the two primary health centres within 
the community. Stable patients are defined as those who are on first-line therapy, are on treatment 
and consistently retained in care for more than 6 months, virologically suppressed and have no other 
health conditions (e,g. TB, pregnancy and other opportunistic infections) requiring attention of a 
clinician. 
3.1.2 Interventions 
For this study, the two models of community ART will be either Adherence Clubs or Home Based ART 
Delivery. 
A. Adherence Clubs 
Adherence clubs will consist of a group of at least 20-25 stable patients who receive care from the 
community health care facility. Members of the club will meet every 3 months at an agreed communal 
venue where they will receive adherence support, symptom screening and pre-packed medications. 
Club members will be required two have 2 clinical/club visits (every 6 months) in a year for their 
routine clinical review and laboratory monitoring. The table below provides a broad overview of an 
ART Adherence Club. 
COMMUNITY ART PROTOCOL V.1.0 
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17 

Table 3. Broad overview of the ART Adherence club 
Membership 
1. 
Group of no more than 25 HIV positive stable patients 
2. 
Should be residing in the clinic catchment area and accessing services 
within the facility 
Club Meetings 
Members will meet every third month (4 club meetings in a year- 2 at 
community level and 2 at facility level 
Clinic/Club Visits 
Members will have a clinic visit once every 6 months 
Members will visit the clinic if the CHiPs refer them. 
Process 
1. During club meetings: 
• 
Members will be assessed (symptom screen) 
• 
Adherence support 
• 
Group education and provision of condoms 
• 
Pre-packed drugs will be dispensed by the CHiPs 
I 
2. Clinical/Club visit 
I 
• 
Every 6 months the club visit will take place in the facility (either a 
particular afternoon or a weekend) 
• 
Clinical review by the clinician for all the club members 
• 
Routine laboratory monitoring for all the club members 
• 
Provision of pre packed drugs 
Data collection 
Data collected during the club meetings will be collected in a hand-held device 
integrated with current smart care system. 
A common place within a particular zone will be identified as a ciub venue provided it is conducive for 
all members. These venues will be consistent and easily identified by the facility and club members. 
The club venues could be in schools, churches, communal clubs etc. and these can also change with 
time as long as this is agreeable with the club members and the health facility. In preparation of each 
club session, the facility in charge, CHiP supervisor and the CHiP should ensure that a few days prior 
to a club meeting: 
Club registers are reviewed to determine which club session will be taking place and in which 
community zone 
Identify and inform the CHiPs about the upcoming club meeting 
Collect members files from the facility registry and deliver to pharmacy for pre-packaging of 
drugs 
Send a reminder via phone call to members of their club meeting and venue. 
The first club meeting will include registration and norms of the club. Thereafter, the first and 
successive club meetings will include: 
Club roster and registration of new members 
Updating contact details of all members 
Signing a charter of agreement about the club rules and norms 
Symptom screen checklist to determine if members have any symptoms 
Weight 
Group education on adherence and risk reduction counselfing 
Dispensing the pre-pack medications upon receiving the prescription slip 
Distribution of condoms 
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For members who are symptomatic and show poor adherence, a referral slip will be given to them to 
refer to the clinician. During the club visits, all data will be entered into an electronic device that is 
programmed to refer a client back to the clinic ifs/he has symptoms or abnormal findings. 
At the end of the visit, members will be reminded of their next club meeting which will be indicated 
on their club card and their bi-annual clinic visits which will be indicated in their ART card. 
If a member is absent during the club visit, this will be recorded in the register and the pre-packed 
drugs will be returned to the clinic. Attempts will be made to call the member to return to the clinic 
to collect his medicine from the pharmacy. 
At the end of the club session, unissued pre-packed drugs will be returned to the pharmacy and 
registers will be updated before handing them over to the facility staff for ensuring completeness of 
the registers. All the data that was collected for each participant in the electronic device will then by 
synced with the clinic database. 
Every 6 months, the club meeting will be conducted at the facility to coincide with their clinical review 
and laboratory monitoring. Club members will be informed to meet on a particular day and time at 
the health facility (this could be an afternoon during the weekdays or a Saturday morning as decided 
by the clinic staff). The club meeting will be conducted as above and in addition all members will be 
reviewed by the clinician and have their routine laboratory tests for monitoring. Drugs will also be pre-
packed prior to this meeting and dispensed to the club members. A 1 x 3 monthly script will also be 
provided. 
B. Home-Based ART Delivery 
This model will provide ART care to clinically stable patients in their homes. The CHiPs will visit the 
participant's homes once every 3 months to provide adherence support, symptom screening and 
dispense pre-packed drugs to the participant. The participant will only be required to visit the clinic 
twice in a year for routine clinical review and laboratory monitoring. The table below provides a broad 
overview of the home-based ART delivery model. 
COMMUNITY ART PROTOCOL V. 1.0 
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19 

Table 4: Broad Overview of the Home-Based ART delivery model. 
Membership 
1. Should be residing in the clinic catchment area and accessing 
services within the facility 
2. 
Clinical stable patient 
3. 
Can include 1-2 members of the same household 
Home visits 
Clients will be visited once every 3 months at their homes 
Clinic Visits 
Clients will have a clinic visit once every 6 months 
Clients will visit the clinic if the CHiPs refer them. 
Process 
1. During home visits: 
• 
Clients will be assessed (symptom screen} 
• 
Adherence support provided 
• 
Health education and provision of condoms 
-
. . 
... . 
. . 
• . l're-pacKed orugs w111 be dispensed 
2. Clinical visit - every 6 months 
• 
Clinical review by the clinician 
• 
Routine laboratory monitoring 
• 
Provision of drug scripts 
• 
Drug dispensation 
Data collection 
Data collected during the home visits will be collected in a hand-held 
device integrated with current smart care system. 
The client's physical address and contact details will be entered in a home-based register, which will 
be updated at every home visit to ensure contact with the client, is maintained. Home and clinic visit 
dates will be provided to the client at each visit and clients will also be reminded they will be called at 
least two days prior to their home visit to schedule the appropriate visit times. 
Once a client has been enrolled into home based ART delivery model, the client will be provided with 
3 monthly prescription slips for the current drug regimen they are on. On the day of registration into 
the model of care, the client will be required to collect a 3 months prescription of drugs to last before 
the first home visit. The facility nurse will ensure that the client has been provided with lx3 monthly 
scripts. 
All clients receiving home-based ART service will be recorded in a register for use at the facility and 
their clinic folders will be kept in a separate filing cabinet specific for home based ART delivery. 
It will be the responsibility of the facility, CHiP supervisor and the CHiP to review the registers on a 
weekly basis to determine the number of home visits scheduled for the week. 2-3 days prior to a home 
visit, the Facility-in-charge and the CHiPs supervisor should ensure: 
• 
Registers are reviewed to see where home visits will take place and in which zone 
• 
Identify and inform the CHiPs about the upcoming home visits and the physical address 
• 
Collect members files from the registry and deliver to pharmacy for pre-packaging of the drugs 
• 
Notify members of their upcoming visits 
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The first home visit will include registration and norms of the visits. Thereafter, the first and successive 
home visits will include the following: 
Updating contact details in the register 
Weighing of client 
Symptom screen checklist 
Health education on adherence and risk reduction counselling 
Dispensing pre-packed drugs and condoms 
Date of next visit 
Reminding clients of their bi-annual clinical visit 
Refer clients who are symptomatic 
For participant's who are symptomatic and show poor adherence, a referral slip will be given to them 
to refer to the clinician. During the home visits, all data will be entered into an electronic device that 
is programmed to refer a client back to the clinic ifs/he has symptoms or abnormal findings. 
At the end of the visit, client will be reminded of the next home visit and clinic visit. These reminders 
will be indicated on their home visit and ART cards. 
If a participant is not found at home during the visit, s/he will be called or anyone present at home 
will be given the message to ask the client to return to clinic to collect drugs. If a participant is 
contacted and agrees to schedule a home visit within 7 days of the missed visit, then the CHiP will 
reschedule the visit. This will be recorded in the register as missed visit and the pre-packed drugs will 
be returned to the clinic. Should a client continue to be absent during home visits on more than 2 
scheduled home visits, s/he will be followed up and transitioned to mainstream care. 
In a household where a couple or two members are both part of this models of care, and one member 
is absent, all efforts must be made to ensure the absent member is followed up for another 
unscheduled visit. 
All the data that was collected for each participant in the electronic device will then by synced with 
the clinic database. 
Every 6 months, the client will be required to visit the health facility for their clinical review and 
laboratory monitoring. In addition they will be given a 3-monthly drug supply and provided with a 1x3 
monthly drug script. All clients in home based care will be required to visit the facility on a certain day 
to ensure that they are fast tracked and received their pre-packed drugs within the facility. 
SCHEDULE OF VISITS FOR BOTH ADHERENCE CLUBS AND HOME-BASED DELIVERY 
Stable patients in both models of care will follow the visit schedule below: 
1. Home or club visits every 3 months (depending on the models of care) 
2. Clinical visit every 6 months 
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Clinic visit for 
151 visit 
enrolment 
0 month 
Month 3 
Clinic Level 
Community Level 
Enrolment into club 
Introductory and 
or home based visit 
standard session in 
both clubs and home 
Norms of the 
based care 
models of ART 
delivery 
Adherence support 
3-month drug 
Symptom screening 
supply 
Dispense 3-monthly 
pre-packed drugs 
znd Visit at the Clinic 
Month 6 
Clinic level 
1. Adherence Clubs: 
Meet at the facility on a 
particular day or weekend 
Conduct the usual club meeting 
at the facility 
Clinical and laboratory review 
3 months pre-packed drugs 
provided 
r lx3 month drug script issued 
2. Home Based ART Delivery 
Clients in this model meet at 
the clinic on a particular day or 
weekend. 
Adherence support by the 
CHiPs 
Clinical review and Laboratory 
rv1onitoring 
Pre-packed drugs dispensed 
issuing of 1x3 month drug 
script 
CLINICAL MANAGEMENT OF CLIENTS IN BOTH MODELS OF CARE 
3rd visit 
4th visit at 
Clinic 
Month 9 
Month 12 
Community Level 
Clinic level 
Standard session 
Same 
Review of results 
procedure as 
in month 6 
Adherence 
support 
Symptom 
screening 
Dispense 3-
monthly pre-
packed drug 
Clients in both models of care will need to be followed up closely to ensure that they are stable and 
this will be done every 6 months at the facility. The 6 month clinical visit will ensure clients receive a 
complete clinical review and routine laboratory tests are conducted. When a client is reviewed by 
the clinician, it will be the clinician's decision to determine ifs/he remains as part of the community 
models of care or return to mainstream care. The criteria for returning to mainstream care include: 
1. Presence of an opportunistic infection (TB) 
2. Detectable viral load 
3. Routine blood results significantly abnormal 
4. Poor adherence to home visits 
5. Patient request 
6. Patient has moved out of the community zone where home-based ART delivery services are not 
available 
Members who belong to the adherence club will be informed that this particular club session will take 
place in the clinic where the Health care workers will conduct a clinical review and laboratory 
monitoring. The standard session of the clubs will also take place during this time and pre-packed 
COMMUNITY ART PROTOCOL V. 1.0 
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22 

drugs will be dispensed to them. In order to expedite this club session, the health care workers and 
club members will agree on a particular day and time when to have the session every 6 months. 
For clients in the home based ART model, they will also be expected to visit the clinic every 6 months 
on a particular day or weekend where their clinical review and laboratory monitoring is fast tracked 
by the community ART nurse. 3 monthly pre-packed drugs will also be provided. 
Once a client has had his clinical visit, the club and home ART register will be updated as having had 
a clinical visit and laboratory results will also be updated. 
If a client has abnormal lab results, s/he will be called to the clinic for review by the clinician. 
All laboratory results should be reviewed by the Facility ART in charge and any abnormal results should 
be discussed with the clinician and the research team. Management of such clients will be according 
to standard practice. 
3.1.3 Inclusion Criteria 
All HIV adult patient (<:: lS years) on first-line ART will be screened for eligibility at the health care 
facility serving the two communities. The eligibility criteria will include: 
• 
All adult patients who are stable. To be considered "stable" a patient must: 
1. Be on first line treatment for more than 6 months and retained in care 
2. Must be virologically suppressed (according to the current standard of care definition of 
viral suppression) 
3. WHO stage I and II at the time of screening 
• 
Patient resides within the clinic catchment area 
• 
Willing to provide written informed consent and accept CHiPs intervention. 
3.1.4 Randomization 
The community zones will be randomized by the research team to one of the three arms: 
1. Arm 1- Patients residing in these zones will be offered a choice of being part of an Adherence 
club or to continue to receive care at the clinic 
2. 
Arm 2 - Patients residing in these zones will be offered a choice of Home ART delivery by the 
CHiP or to continue receiving care at the clinic 
3. 
Arm 3- Patients residing in these zones will continue receiving care at the clinic (control arm). 
Across the two communities (Chipata and Kanya ma), there are 104 community zones that will be 
randomized to one of the three arms above. 
Comri\u~ity : TC>tal number of z~ne~ 
~~at~'- ... 
50 
17 zones 
104 
35 
COMMUNITY ART PROTOCOL V. 1.0 
10 JANUARY 2017 
18 zones 
18 zones 
17 zones 
16 
35 
34 
23 

3.1.5 Study Procedures 
Once the community zones have been randomized, the research team and clinic staff will screen 
participants for eligibility at the health facility. This includes patients who are taking ART for at least 6 
months or more and are clinically stable. If found to be eligible, the research team will explain the 
study and ask for written consent to take part in the study. The research team will then inform eligible 
participants which model they have been allocated to or whether they will continue to receive care at 
the facility. Participants allocated to one of the two community ART models will be offered a choice 
of whether they would prefer to receive this model or continue receiving care within the health 
facility. Participant choice will be recorded and participants opting for community ART delivery will be 
linked up with their respective CHiP teams to either register for a club or to start home delivery. 
Participants in these intervention arms may change their mind at any time either opting to move to 
the community model or to move back to the clinic model. Again this information will be recorded as 
an outcome measure 
4.0 Study Outcomes 
The primary and secondary objectives for this study are listed in Section 2.2. The outcome measures 
for these objectives are listed below and will be measured in all study arms unless otherwise noted. 
A. Primary Outcome - viral suppression at 12 months measured using the standard of care viral load 
testing equipment currently in place. Viral suppression will be defined according to National guidelines 
B. Secondary Outcomes - these will include: 
1. Viral suppression at 24 months- undetectable HIV viral load 24 months after entry into the models 
of care. This will be done as part of routine laboratory monitoring and measured using routine 
programmatic data. 
2. Retention in care/ Loss to Follow-up-Loss to follow-up from ART programmes describes all patients 
who are no longer in care and have an unknown outcome. A most useful definition of "loss to follow-
up" should refer to patients with unknown outcomes(49). For this study, LTFU will be defined as "no 
patient contact for 90 days or longer after the last given appointment". 
Retention in care refers to all patients retained in the HIV program. Patients who are no 
longer retained in care with unknown outcomes will be classified as LTFU. 
• 
In this study, retention will be defined as the number(%) of clients who are retained 
in the program at 6, 12 and 24 months after implementation of the intervention. 
• 
The time to Lost to follow-up will be calculated in months according to the time 
interval between the dates of entry into the intervention to drop out, as recorded in 
the routine programmatic data. 
• 
Proportion of patients that returned to mainstream care at 6, 12 and 24 months. 
3. HIV disease progression - defined as having a new or recurrent WHO stage 3 or 4 condition after 6 
months of ART, or a fall in CD4 count, (1). For patients with baseline CD4 count of< 200 cells/ul a fall 
of CD4 count to baseline or below after 6 months of ART; or persistent CD4 count< 100 cells/ul after 
6 months of ART. (2). For patients with baseline CD4 count ~ 200 cells/ul, a persistent decline in CD4 
count after two or more tests. For this study we will determine the following using routine health 
centre data: 
COMMUNITY ART PROTOCOL V. 1.0 
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24 

• 
Proportion of patients who have had their CD4 count tests done at 6, 12 and 24 months after 
entering the models of care 
• 
Proportion patients who developed a WHO stage 3 or 4 condition at 6, 12 and 24 months 
• 
Proportion of patients with CD4 count below 200 at 6, 12 and 24 months despite on 
treatment. 
4. Death - defined as death at any point during the intervention due to any HIV related cause after 
enrolment into the study. 
5. Participant choice of model and retention within that model. The following outcomes will be 
measured using programmatic and routine health centre data: 
• 
Proportion of patients who enrolled into the models of care by sex 
• 
Proportion (%) of eligible patients but refused to enter the model of care at baseline 
• 
Proportion of patients who switched back to mainstream care at 6, 12 and 24 months and 
reasons for switching 
• 
Number of club sessions and home visits that took place at 12 and 24 mohths after start of 
intervention 
6. Drug Supplies -using routine health centre and programmatic data, we will determine: 
• 
Number of groups/individuals missing at least one refill in the last 12 and 24 months (ART, 
Cotrimoxazole) 
• 
Missed dispensations of ARVS at 6, 12 and 24 months. 
• 
Proportion of pre-packed drugs returned to the clinic after a club session or home-based visit. 
• 
Number of reported cases of ART drugs being pilfered after the start of the intervention. 
7. Qualitative evaluation- of the acceptability and functioning of the two models of community ART 
delivery based on systematic structured observations of delivery, in-depth interviews and focus group 
discussions with key-informants (CHiPs, health facility staff) and longitudinal interviews with PLWH. 
8. Economic Analysis - this will include: 
• 
Measuring and comparing the incremental costs of the two intervention packages. The 
economic analysis will focus on measuring economic costs of the interventions from 
provider's perspective. The main focus will be on costs to the health services, including 
personnel, equipment and materials. The incremental cost of the interventions will be 
estimated by comparing costs of service provision and healthcare utilization with non-
intervention healthcare facilities. 
• 
Measure the impact of implementing the community ART delivery models on health systems 
and service delivery at local health centres in terms of technical and allocative efficiency 
of available HIV resource. 
5.0 Data Collection and Tools 
Data will be collected at the following points: 
Baseline 
COMMUNITY ART PROTOCOL V. 1.0 
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25 

Three (3) months 
Six (6) months 
Twelve (12) months 
Twenty four (24) months 
Routine data will be collected using the national HMIS system and patient clinic records. At baseline, 
the following variables will be collected from patients to determine their influence on the outcomes: 
• 
Age, sex, weight 
• 
Recent CD4 count before enrolling into the models of care 
• 
Viral load 
• 
WHO stage at enrolment 
• 
Date of starting ART 
e 
Current drug regimen. 
To maximize the validity of this information, the study team will work closely with the health centres 
to improve the collection and management of these routine data. 
Data captured from the community models of ART delivery will be collected using the same hand held 
collection device being used in the main HPTN trial. A specific programme for this model will be 
installed in the device. This program is designed to maximize the quality of data collection using drop 
down lists and incorporating checks to avoid simple data entry errors. The CHiPs will undergo forrnal 
training on how to use the software to capture data at community level and sync it with the facility 
database and this training will be documented and retained in the site files. 
Under the leadership of the Zambian Ministry of Health, the community ART steering committee has 
agreed upon a set of core indicators to be used to monitor and evaluate the community ART service 
delivery models being piloted by different partners. To facilitate the collection of the key indicators 
across both models, a list of common indicators will be used and this will be captured from both smart 
care and routine programmatic data. 
Appendix 2 gives a detailed description of the data captured by the Chips in both Adherence clubs and 
home-based visits. The EDC program will capture data as required by the National ART community 
module for stable on care patients which has been developed by EGPAF and implementing partners. 
The following data will be captured in the device during the community ART model visits: 
At clinic level: 
• 
Patient ART registration details- Name, Sex, Age, ART number 
At community level (Adherence Clubs and Home based Visits) 
• 
Date of visit 
• 
Symptom Screen (fever, weight loss, cough, headache) 
• 
Pregnancy screening for females 
• 
Adherence counselling and types of counselling 
• 
Pre-packed drugs dispensed 
• 
Services referred for PMTCT, ART, STI, VMMC, etc. 
• 
Next community and clinic visit appointment 
Data captured electronically during community visits will be linked to the HIV care databases at the 
health centre. The study team will work closely with the Ministry of Health and implementing partners 
COMMUNITY ART PROTOCOL V. 1.0 
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26 

supporting the sites to collect relevant data from both the supply and demand side. Data that will be 
captured electronically during the club and home visits will be synced at the end of the day with the 
health care centre database. This is to ensure that indicators used for routine monitoring and follow-
up will be entered in the current smart care system at facility level. The table below summarizes the 
core indicators that will be collected at both facility and community levels for the purpose of 
monitoring and evaluation. 
Table 6: Common indicators for community ART models 
Common Indicators for Community ART Models of Care 
Main 
Core Indicator 
1. Recruitment 
Proportion of patients enrolled into Home-Based ART models by sex 
Proportion eligible but refused 
Proportion of patients dropping out (within 1,3,6 and 12 months) 
CD4 count at enrolment 
Time on ART before enrolment 
2. Retention 
Number{%) of clients retained at 1,3,6,12 and 24 months 
Loss to follow up by reason: 
• 
Dead 
• 
Transfer 
• 
Lost 
Number of patients returned to mainstream care ( @ 3, 6. 12, 24 
months) 
% of clients who developed an 01 @ 3, 6, 12 and 24 months 
3. Laboratory 
Proportion of patients who have had viral loads within the last 6 
months 
Proportion of patients who have had CD4 count in the last 6 months 
Proportion of patients with viral suppression at 12 and 24months 
Proportion of patients with CD4 count below 500 in the last 12 
months despite treatment 
4. Drug Supplies 
Number of individuals missing at least one refill in the last 6 and 12 
months 
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Data Source 
Smart care I HMIS 
Consenting register 
Routine data/ 
Programmatic data 
Smart care 
Smart care 
Smart care 
Smart care 
Smart care 
Smart care and routine 
programmatic data 
Smart care and routine 
programmatic data 
Smart care and routine 
programmatic data 
Smart care and routine 
programmatic data 
Smart care and routine 
programmatic data 
Smart care and routine 
programmatic data 
27 

Additional data collected for measuring the outcomes of the study objectives will be collected from 
patient clinical records. The key clinical indicators will be collected from smart care and HMIS and 
these includes: 
• 
Proportion of patients with continuous immunologic/virologic suppression 
• 
Proportion of patients who develop opportunistic infections in the models of care 
• 
Transition rates of newly eligible patients into the community models 
• 
Transition rates of patients from community models back to facility care 
Data Security 
Data will be securely stored according to Ministry of Health and Smart Care guidelines that are already 
in place for all health care centres providing HIV care. All CHiPs involved in community of ART model 
delivery will have to sign a consent form as per smart care National Guidelines which explicitly explains 
data confidentiality and respect of clients. Data captured electronically in the device is encrypted and 
once it is synced with the health centre database, protected by Microsoft SQL security. Access of aii 
data in the health centre database will be based on user right and every user in the facility has to agree 
to terms of use, which is currently in place. The Audit Trail in Smart Care that is currently in place in 
all ART health centres logs key events, which occur in the system. It logs information such as who 
logged into the system, which patient reports they run, changes to inventory and who created a back 
up. Every single interaction has the identifier of whoever entered the data as well. This trail will be 
used for security and audit purposes. 
In order to obtain the data for monitoring and evaluation as well as for research purposes both by 
implementing partners and Zambart research teams, permission will be sought from the Ministry of 
Health. The study team wiii then periodically extract this data for measuring the outcomes of the 
study. 
Investigators will also allow inspection of all study-related documentation by authorized 
representatives of the HPTN LOC, SDMC, LC, NIAID, US and in-country government and regulatory 
authorities and IRBs/ECs. A site visit log will also be maintained at the study site to document all visits. 
Qualitative Data Collection 
Participants will include CHiPs and health facility staff involved in the models of care and based at the 
two urban health facilities and PLWH will be selected based on their qualitative representation of 
particular gender, age, experience and (for PLWH) household groups. Participant numbers will be 
relatively small. We estimate that participants will include approximately four CHiPs and four health 
facility staff in each of the two sites and 12 PLWH in each of the two sites. 
Semi-structured key informant in-depth interviews (IOI) with health facility staff and CHiPs will be 
conducted at the two facilities. In addition, one focus group discussion in each site with CHIPs will also 
be conducted. These two data collections activities (FGDs and I Dis) will only be conducted once after 
one year and six months into the intervention. 
For PLWH, data will be collected through focus group discussions (FGD) as well as in-depth interviews 
(IOI) for those that will not be comfortable with participating in FGDs. These activities will also be 
conducted once after one year and six months into the intervention. Moreover, Structured 
observations of the two delivery models and routine care will be carried out intermittently (Quarterly 
from the start) by Zambart social scientists in the two mentioned sites. 
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In addition, other existing social science data collected as a component of the wider PopART trial will 
be reviewed to help develop the research tools to be used (IDls, structured observations and FGDs) 
and for comparative interpretation. For example, drawing on data on PLWH involved in other 
longitudinal enquiry in other PopART communities who are continuing to go to the health facility for 
care. 
Key themes would include: the impact of the models of care on livelihood options, HIV related stigma 
and social relations; satisfaction with the modes of delivery; and comparison with routine ART delivery 
at the public health facility. 
The data from this study will be transcribed, coded and managed using ATLAS ti and analysed using 
key themes and interdisciplinary discussion about key outcomes. 
Economic Analysis 
This will be embedded in the community models of ART delivery to compare the incremental 
of 
delivering the two models. Patient specific resource utilization data will be collected prospectively 
alongside the main study. We will generate estimates of the costs to the health care system of 
providing the interventions, such as packaging of drugs for the models, stationary used and trainings. 
We will also consider recurrent costs for personnel (wages and related costs), laboratory tests, 
materials, equipment and supplies etc. Direct health benefits will also be measured by triangulating 
HIV disease progression and death data, and secondary data on quality of life and disability. Data 
sources will include case report forms and study records. Secondary sources such as peer reviewed 
publications and grey literature will be reviewed to complement primary data. 
6.0 Process Evaluation 
For the purpose of this study, we will largely follow the indicators currently used in the national smart 
care system and the community ART model core indicators in section 5. Standard reports documenting 
this will be generated and reviewed by the study team and discussed with field teams at monthly 
management meetings and appropriate corrective actions implemented. 
A consolidated report will be generated monthly which will be reviewed by the entire study leadership 
team on regular scheduled calls. A quarterly report will be developed to share with the national 
community ART steering committee, Ministry of Health and other implementing partners. This is to 
ensure transparency, accountability of patient clinical management, antiretroviral therapy 
management, adherence support and logistic supplies. 
Site visits will be conducted by the in-country leadership to review procedures on the ground and 
implement any corrective action. 
7.0 Statistical Analysis 
The analysis will compare each of the two trial intervention arms with the "standard-of-care" (control 
arm), and the primary endpoint is viral suppression at 12 months after study enrolment. The analysis 
will be done using standard methods for a cluster- randomized trial with a non-inferiority design. 
COMMUNITY ART PROTOCOL V. 1.0 
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29 

The study has been designed to a study power of between 73 -94% to demonstrate that a trial 
intervention arm is not inferior to the 11standard-of-care" arm for the percentage of participants who 
are virologically suppressed at 12 months after study enrolment. The definition of 11not inferior" is that 
the percentage of study participants who have died, or are alive but not virally suppressed, at 12 
months after enrolment in a trial intervention arm is::> 5% higher than in the standard-of-care arm. 
Based on the data from the annual first round of the CHiP intervention in the main trial, the number 
of adults who are known by the CHiP teams to be HIV-positive and to be taking ART at the time of the 
most recent CHiPs follow-up visit averages approximately 50 per zone, with a harmonic mean of 
approximately 36 per zone. Assuming that 80% of such adults agree to participate in the study and 
have not moved out of the community within 12 months after enrolment, the number of study 
participants per zone who can contribute to the primary endpoint measurement will have a harmonic 
mean of approximately 30. 
Study po\Ner calculations have been done Vv'ith the assumption that an average of 30 study participants 
per zone will contribute to the measurement of the primary endpoint; that 35 zones are randomized 
to the 2 intervention arms and 34 zones to the 11standard-of-care" arm; and that among study 
participants in the 11standard-of-care" the percentage who have died, or are alive but not virally 
suppressed, 12 months after enrolment to the study is in the range 10-15%. It is aiso assumed that 
the coefficient of variation k, of the variation across zones in the percentage of study participants who 
have either died or are alive but not virally suppressed at 12 months after study enrolment, is in the 
range 0.25 to 0.3. If the percentage of participants who have died or are alive but are not virally 
suppressed at 12 months after study enrolment is 10~~ in the "standard-of-care/} arm, and k=0.25 or 
k=0.3, study power is 93% and 91% respectively to show that a trial intervention arm is not inferior to 
11standard-of-care". The corresponding study power figures are 78% and 74% if the percentage of 
participants who have died or are alive but are not virally suppressed at 12 months after study 
enrolment is 15% in the "standard-of-care arm". 
Table summarising study power to show that community ART provision is not inferior to standard-
of-care, in terms of patient viral suppression 12 months after either enrolling into community ART 
or continuing with standard-of-care at the clinic 
Standard of care, % 
Intervention, 
Coefficient 
Number of 
Study 
not virally suppressed 
% not virally 
of variation k 
participants per 
power(%) 
at 12 months after 
suppressed at 12 
duster 
enrolment 
months after 
enrolment 
5% 
::>10% 
0.25 
30 
99% 
10% 
::::15% 
0.25 
30 
93% 
15% 
::::20% 
0.25 
30 
78% 
5% 
::::10% 
0.30 
30 
99% 
-
10% 
::::15% 
0.30 
30 
91% 
15% 
::::20% 
0.30 
30 
74% 
We will also use qualitative and quantitative methods to evaluate the acceptability and feasibility of 
the two models of ART delivery and the barriers to access in care. Interviews would look at the 
trajectory of linking to care, reflecting on the HIV pathways and care choices prior to the 
intervention and after and exploring their comparative experience with satisfaction of care and 
COMMUNITY ART PROTOCOL V. 1.0 
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30 

patient rights, HIV related stigma, household and other social relationships, livelihood pursuits and 
wellbeing. 
The main focus of the economic analysis will be the cost of the models including equipment, materials, 
laboratory tests and personnel. Cost estimates will be collected for each of the resource items 
identified from the case report forms and study records. All cost data will be presented in Zambian 
Kwacha and in US$. Data will be entered and cleaned in excel. Patient specific resource use data will 
be coupled with the unit cost estimates to generate a patient specific cost estimate. Mean patient 
costs will be calculated separately for study intervention arms and standard statistical analysis 
undertaken. Data analysis will be performed in both Microsoft (MS) excel and Stata-version 13.0. 
A cohort model will be developed combining the costs and benefits from the intervention. This 
approach will provide a conservative estimate of the cost-effectiveness of the intervention, as it will 
only consider the direct health benefits of the trial participants and not account for the indirect health 
benefits (such as QALY gains or DALYs averted from the secondary infections avoided). 
8.0 Ethical Consideration 
8.1 Ethical Review 
Researchers will obtain ethical clearance from the relevant authorities at the University of Zambia, 
Biomedical Research Ethics Committee. Permission will also be sought from the Ministry of Health, 
Lusaka District Health Management Team (DHMT) to conduct the study in Chipata and Kanyama 
communities. 
Participants will be approached to obtain written consent for taking part in the study. A standardized 
consent form will be reviewed by the Biomedical Research Ethics Committee of the University of 
Zambia between researchers and study participants prior to any intervention, interview and I or 
discussions. By and large, researchers will provide enough information about the study to the study 
participants to help them comprehend the purpose of this study, study benefits and risks to enable 
them make well informed decisions to either participate or not. 
8.2 Participant Withdrawal 
All study participants will retain the right to withdraw at any stage from the study interventions. 
Participants who withdraw from the intervention arms will be transitioned to continue care at the 
clinic whilst remaining in the study. 
Participants will also be withdrawn from the study and transitioned to continue care at the clinic ifthe 
study may be discontinued at any time by the National Institute of Allergy and Infectious Diseases 
(NIAID), the HPTN, other government or regulatory authorities and/or site Institutional Review boards 
(IRB)/ Ethics Committee (EC). 
8.3 Anticipated Risks 
Researchers recognize the fact that there might be breach of confidentiality among health workers 
and CHiPs as a result of the study. The interaction of the CHiPs and research staff with various health 
workers within the study sites may disclose participant's personal and confidential information to 
COMMUNITY ART PROTOCOL V. 1.0 
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31 

researchers. For this reason, all research staff will receive good clinical practice/research ethics 
training at the beginning of the study. All research staff and CHiPs will be counselled to observe 
maximum confidentiality of any information revealed to then during and after the study. 
8.4 Benefits to the Study Participants 
There will be no direct and immediate benefit in terms of monetary and/or material benefit during 
and/or at the end of the study. For this reason the participants will be well informed that their 
participation is purely voluntary and that they have the right to withdraw at any time. 
Benefits anticipated to the participants include less frequent travel to the clinics for their pharmacy 
refill; reduce waiting time and privacy within the clubs and their homes. 
8.5 Dissemination of research findings and final report 
Preliminary findings of the study will be shared with our Ministry of Heaith and implementing partners 
during the technical working group meetings. We will continue providing progress reports every 6 
months and final report at the end of the study will be shared with different partners including the 
Ethics Committee, Lusaka DHMT and Ministry of Health. Research findings will also be made available 
to the Ministry of health and in country implementing partners in order to inform policy guidelines 
regarding scaling up of community ART models. Based on these findings, researchers will make 
recommendations to all stake holders on how to improve community ART models for the country. 
Additionally peer- reviewed research publications will be submitted under the auspice of Zambart 
intended for both local and international information users. 
9.0 Administrative Procedures 
Prior to implementation of this protocol, and any subsequent full version amendments, each site 
must have the protocol and the protocol informed consent form(s) approved, as appropriate, by 
their local institutional review board (IRB)/ethics committee (EC) and any other applicable regulatory 
entity (RE). Upon receiving final approval, sites will submit all required protocol registration 
documents to the DAIDS Protocol Registration Office (DAIDS PRO) at the Regulatory Support Center 
(RSC). The DAIDS PRO will review the submitted protocol registration packet to ensure that all of the 
required documents have been received. 
Site-specific informed consent forms (ICFs) WILL NOT be reviewed or approved by the DAIDS PRO, 
and sites will receive an Initial Registration Notification when the DAIDS PRO receives a complete 
registration packet. Receipt of an Initial Registration Notification indicates successful completion of 
the protocol registration process. Sites will not receive any additional notifications from the DAIDS 
PRO for the initial protocol registration. A copy of the Initial Registration Notification should be 
retained in the site's regulatory files. 
Upon receiving final IRB/EC and any other applicable RE approval(s) for an amendment, sites should 
implement the amendment immediately. Sites are required to submit an amendment registration 
packet to the DAIDS PRO at the RSC. The DAIDS PRO will review the submitted protocol registration 
packet to ensure that all the required documents have been received. Site-specific ICF(s) WILL NOT 
be reviewed and approved by the DAIDS PRO and sites will receive an Amendment Registration 
Notification when the DAIDS PRO receives a complete registration packet. A copy of the Amendment 
Registration Notification should be retained in the site's regulatory files. 
~???S??S??S??S??S??S&m??S??S??S??S??S??S??S??Smm~mm1m·??S??S??S??S??S??S??S??S??S
1 ~!??S??S??S•"•~~??S??S??S~& 
COMMUNITY ART PROTOCOL V. 1.0 
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32 

For additional information on the protocol registration process and specific documents required for 
initial and amendment registrations, refer to the current version of the DAI DS Protocol Registration 
Manual. 
10.0 Budget 
There will be small costs associated with this ancillary study. Most activities will be carried out by 
staff already in position in the main HPTN -071 (PopART) trial. Some additional budget lines are 
needed to support additional requirements for data; pharmacy and field staff and these funds will be 
covered by the revised PopART budget. This is currently in place through research and PEPFAR COP 
2016. 
11. Study Timeline 
Timellne for implementation, Monitoring and Evaluation of Community ART models 
Protocol 
Development and 
IRB approval 
Training of HCW 
and CHIPs 
Enrolment 
Data entry and 
collection 
Data analysis 
Monitoring and 
Evaluation 
Final Review and 
Dissemination 
Months 
2 
4 
'llf1.1r\'1l Jr·!l I Y /\111 l'I{() I c11 01 \I 1.11 
1 ll J1\l•!ll/\RY !(ii l 
6 
8 
10 
12 
14 
16 
18 
20 
22 
24 
26 
28 

12. References 
1. 
.UNAIDS. The Gap Report. 2014. 
2. 
UNAIDS. UNAIDS AND MEDECINS SANS FRONTIERES 2015/REFERENCE: COMMUNITY-BASED 
ANTIRETROVIRAL THERAPY DELIVERY/EXPERIENCES OF MSF. GENEVA, SWITZERLAND: 2015. 
3. 
Central Statistic Office (CSO} [Zambia]. Zambia Demographic and Health Survey 2013-14. 
4. 
Council NA. GARPR Zambia Country Report 2014. : Ministry of Health; 2015. 
5. 
WHO. Guidelines on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. 
Geneva2015. 
6. 
CD4+ Count-Guided Interruption of Antiretroviral Treatment. New England Journal of Medicine. 
2006;355(22):2283-96. 
7. 
Sanjana P, Torpey K, Schwarzwalder A, Simumba C, Kasonde P, Nyirenda L, et al. Task-shifting HIV 
counselling and testing services in Zambia: the role of lay counsellors. Human resources for health. 
2009;7(1}:44. 
8. 
Zachariah R, Teck R, Buhendwa L, Labana S, Chinji C, Humblet P, et al. How can the community 
contribute in the fight against HIV/AIDS and tuberculosis? An example from a rural district in 
Malawi. Transactions ofthe Royal Society ofTropical Medicine and Hygiene. 2006;100:167 - 75. 
9. 
Hirschhorn L, Oguda L, Fullem A, Dreesch N, Wilson P. Estimating health workforce needs for 
antiretrovirai therapy in resource-iimited settings. Human resources for health. 2006;4(1}:1. 
10. Samb B, Celletti F, Holloway J, Van Damme W, De Cock KM, Dybul M. Rapid Expansion of the 
Health Workforce in Response to the HIV Epidemic. New England Journal of Medicine. 
2007;357(24):2510-4. 
11. Zambian Minstry of Health: Human resources for health strategic plan (2007-2010). Lusaka, 
Zambia: Printech Press~ 2006. 
12. Morris MB, Chapula BT, Chi BH, Mwango A, Chi HF, Mwanza J, et al. Use of task-shifting to rapidly 
scale-up HIV treatment services: experiences from Lusaka, Zambia. BMC Health Serv Res. 
2009;9(5):1472-6963. 
13. Ford N, Calmy A, Mills EJ. The first decade of antiretroviral therapy in Africa. Globalization and 
health. 2011;7:33. Epub 2011/10/01. 
14. WHO. March 2014 supplement to the 20B consolidated guidelines on the use of antiretroviral 
drugs for treating and preventing HIV infection. Geneva2014. 
15. Fatti G, Grimwood A, Bock P. Better antiretroviral therapy outcomes at primary healthcare 
facilities: an evaluation of three tiers of ART services in four South African provinces. PloS one. 
2010;5(9}:e12888. Epub 2010/09/30. 
16. Mills EJ, Nachega JB, Bangsberg DR, Singh S, Rachlis B, Wu P, et al. Adherence to HAART: a 
systematic review of developed and developing nation patient-reported barriers and facilitators. 
PLoS Med. 2006;3(11}. 
17. World Health Organization. Consolidated Guidelines on the use of antiretroviral drugs for treating 
and preventing HIV infection: recommendations for a public health approach. Geneva: World 
Health Organization 2013. 
18. Cohen M et al. Final results of the HPTN 052 randomized controlled trial: antiretroviral therapy 
prevents HIV transmission. 8th International AIDS Society Conference on HIV Pathogenesis TaP. 
COMlv'IUNITV 
JA~JUARY 

19. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention 
of HIV-1 infection with early antiretroviral therapy. The New England journal of medicine. 
2011;365(6) :493-505. Epub 2011/07 /20. 
20. Dodd PJ, Garnett GP, Hallett TB. Examining the promise of HIV elimination by 'test and treat' in 
hyperendemic settings. AIDS. 2010;24:729-128. 
21. Granich R, Kahn JG, Bennett R, Holmes CB, Garg N, Serenata C, et al. Expanding ART for treatment 
and prevention of HIV in South Africa: estimated cost and cost-effectiveness 2011-2050. PloS one. 
2012;7(2):e30216. Epub 2012/02/22. 
22. Maman D MS, Chilema B, Masiku C, Szumilin E, Ayouba A, et al. Low incidence and high population 
viral suppression in Malawi: the Chiradzulu HIV Incidence Study. Conference on Retroviruses and 
Opportunistic Infections (CROI); Boston, USA2014. 
23. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. New England Journal of 
Medicine. 2015;373(9):795-807. 
24. Rosen S FM, Gill CJ. Patient retention in antiretyroviral therapy programs in sub-Sharan Africa: a 
systemic review. PloS Med. 2007;4:e298. 
25. Fox MP, Rosen S. Patient retention in antiretroviral therapy programs up to three years on 
treatment in sub-Saharan Africa, 2007-2009: systematic review. Tropical Medicine & 
International Health. 2010;15:1-15. 
26. Fox M RSPriatil-am-icsropaasHaDdP. 
27. Grimsrud AT CM, Egger M, Boulle A, Myer L. Impact of definitions of loss to follow-up (LTFU) in 
antiretroviral therapy program evaluation: variation in the definition can have an appreciable 
impact on estimated proportions of LTFU. Journal of Clinical Epidemiology. 2103;66:10006-1013. 
28. Meintjes et al. 2012. Guidelines for antiretroviral therapy in adults by the Southern African 
HIVClinicians Society. SAJHIVMED 13, 114-133. 
29. Kredo T, Ford N, Adeniyi FB, Garner P. Decentralising HIV treatment in lower- and middle-income 
countries. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD009987. DOI: 
10.1002/14651858.CD009987 .pub2. 
30. Amuron B, Coutinho A, Grosskurth H, Nabiryo C, Birungi J, Namara G, et al. A cluster-randomized 
trial to compare home based with health facility-based antiretroviral treatment in Uganda:study 
design and baseline findings. Open AIDS J.2007;1:21-7. 
31. Amuron B, Namara G, Birungi J, Nabiryo C, Levin J, Grosskurth H, et al. Mortality and loss-to-follow-
up during the pre-treatment period in an antiretroviral therapy programme under normal health 
service conditions in Uganda. BMC public health. 2009;9(1):290. 
32. Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, et al. Rates of virological failure in 
patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast 
Uganda: 
a cluster-randomised equivalence trial. 
Lancet. 
2009;374(9707):2080-9. 
Epub 
2009/11/27. 
33. Kipp W, Kon de-Lule J, Saunders LD, Alibhai A, Houston S, Rubaale T, et al. Antiretroviral Treatment 
for HIV 
in 
Rural 
Uganda: Two-Year Treatment Outcomes of a Prospective 
Health 
Centre/Community-Based and Hospital-Based Cohort. PloS one. 2012;7(7):e40902. 
34. Kipp W, Konde-Lule J, Saunders LD, Alibhai A, Houston S, Ru baa le T, et al. Results of a community-
based antiretroviral treatment program for HIV-1 infection in Western Uganda. Curr HIV Res. 
2010;8(2):179-85. 
COMMUNITY ART PROTOCOL V. 1.0 
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35. Selke HM, Kimaiyo S, Sidle JE, Vedanthan R, Tierney WM, Shen C, et al. Task-shifting of 
antiretroviral delivery from health care workers to persons living with HIV I AIDS: clinical outcomes 
of a community-based program in Kenya. J Acquir Immune Defic Syndr. 2010;55(4):483-90. 
36. Mbonye M, Seeley J, Ssembajja F, Birungi J, Jaffar S. Adherence to Antiretroviral Therapy in Jinja, 
Uganda: A Six-Year Follow-Up Study. Sandberg JK, ed. PLoS ONE. 2013;8(10):e78243. 
doi:l0.1371/journal.pone.0078243. 
37. Alibhai A, Martin LJ, Kipp W, Konde-Lule J, Saunders LD, Rubaale T, et al. Quality of life of HIV 
patients in a rural area of western Uganda: impact of a community-based antiretroviral treatment 
program. Curr HIV Res. 2010;8(5):370-8. 
38. Kipp W, Konde-Lule J, Rubaale T, Okech-Ojony J, Alibhai A, Saunders D. Comparing antiretroviral 
treatment outcomes between a prospective community-based and hospital-based cohort of HIV 
patients in rural Uganda. BMC !nternationa! Health and Human Rights. 2011;11(Supp! 2):512. 
39. Kipp W, Konde-Lule J, Rubaale T, Okech-Ojony J, Alibhai A, Saunders DL. Comparing antiretroviral 
treatment outcomes between a prospective community-based and hospital-based cohort of HIV 
patients in rural Uganda. BMC International Health and Human Rights. 2011;11(Suppl 2):S12-S. 
40. Wools-Kaloustian K, Sidle J, Selke H, Vedanthan R, Kemboi E, Boit L, et al. A model for extending 
antiretroviral care beyond the rural health centre. Journal of the International AIDS Society. 
2009;12(1):22. 
41. httQ)_LwWVlfJ!lJ>fgi:gfuticle/hivaids-communi!Y-models-care-explained 
[database 
on 
the 
Internet]. 
42. Bemeimans ivi, Bae rt S, Goemaere E, Wilkinson L, Vandendyck M,van Cutsem G, et al. Community-
supported models of care for people on HIV treatment in sub-Saharan Africa. Tropical medicine & 
international health: TM & IH. 2014;19(8):968-77. Epub 2014/06/04. 
43. Wilkinson LS. ART adherence clubs: A long-term retention strategy for clinically stable patients 
receiving antiretroviral therapy2013. 
44. Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, 
et al. Effectiveness of Patient Adherence Groups as a Model of Care for Stable Patients on 
Antiretroviral Therapy in Khayelitsha, Cape Town, South Africa. PloS one. 2013;8(2):e56088. 
45. Decroo T, Koole 0, Remartinez D, dos Santos N, Dezembro S, Jofrisse M, et al. Four-year retention 
and risk factors for attrition among members of community ART groups in Tete, Mozambique. 
Tropical medicine & international health: TM & !H. 2014;19(5):514-21. Epub 2014/06/06. 
46. Decroo T, Telfer B, Biot M, Maikere J, Dezembro S, Cumba LI, et al. Distribution of antiretroviral 
treatment through self-forming groups of patients in Tete Province, Mozambique. J Acquir 
Immune Defic Syndr. 2011;56(2):e39-44. Epub 2010/11/19. 
47. Chishinga N, Godfrey-Faussett P, Fielding K, Ayles H. Effect of home-based interventions on 
virologic outcomes in adults receiving antiretroviral therapy in Africa: a meta-analysis. BMC public 
health. 2014;14:239. Epub 2014/03/13. 
48. Decroo T, Rasschaert F, Telfer B, Remartinez D, Laga M, Ford N. Community-based antiretroviral 
therapy programs can overcome barriers to retention of patients and decongest health services 
in sub-Saharan Africa: a systematic review. International health. 2013;5(3):169-79. Epub 
2013/09/14. 
49. World Health Organization. Retention in HIV Programmes defining the challenges and identifying 
solutions: meeting report, 13-15 September 2011. Geneva2012 2011. 
COMMUNITY ART PROTOCOL V. 1.0 
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Appendix 1. INFORMATION SHEET AND INFORMED CONSENT FORM FOR COMMUNITY 
ANTIRETROVIRAL THERAPY DELIVERY 
INFORMATION SHEET 
You are being invited to take part in a new type of Anti-Retroviral Therapy (ART)service delivery 
for HIV stable patients. This is called "Community Models of ART care" and these models include 
the following: 
1. Adherence club 
2. Home-Based ART delivery 
3. Continue care at the local facility 
Adherence Club 
The ART adherence club will consist of a group of 20-25 clinically stable HIV patients from this 
clinic. The members will meet every 3 months at a communal venue in your community where 
HIV adherence support, a symptom screening and pre-packed drugs will be provided. 
Community HIV Care Providers (CHiPs) that work in your community will conduct these activities 
and members will be required to visit the clinic once every 6 months for the next 2 years till the 
end of the study 
Home-Based ART delivery 
In this model, the Community HIV Providers (CHiPs) will visit people at home once every 3 months 
to provide them with adherence support, carry out a symptom screening and dispense pre-
packed ART drugs. People who will be part of this model, will only visit the clinic once every 6 
months for the next two years till the end of the study. 
Continued Access of care at the local clinic 
In this model, people will continue to receive care at the local clinic and follow the routine clinic 
visits that they have been following ever since they started Antiretroviral Therapy (ART). 
We are therefore inviting you to participate in this study to see which model works best for the 
community. Within your community there are several zones and each zone will either have an 
adherence club, a home based ART delivery or continue receiving care at your local clinic. 
Information about the study is supplied in this document. Please make sure that you 
understand everything described in this document. If you decide to participate,· you will be 
asked to give written consent before you take part. If you sign this form, you will be giving your 
permission to take part in the study. 
This form describes reasons for doing the study, how we will conduct the study and the benefits 
and risks of the study. 
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Your participation is voluntary 
You do not have to take part in these models of ART service delivery. If you decide today to take 
part in this study, you may stop at any time without reducing or affecting any care that you 
receive at this clinic or anywhere else. If we learn any new information during the course of the 
study that might make you concerned about continuing, we share that information with you. 
If you are offered community-based ART, but decide today to continue care at the clinic, you may 
change your mind later and if you are still living in the same area, you will then begin receiving 
ART in your community. If you accept community-based ART at any time, you can always decide 
later to go back to receiving ART at the clinic. 
Who is doing the study? 
Researchers from the Zambia AIDS Related Tuberculosis (ZAMBART) Project in conjunction with 
Ministry of Health will be conducting this pilot model in your community. 
The study has been approved by the Medical Ethics Committees of the University of Zambia and 
the London School of Hygiene and Tropical Medicine. 
What is the purpose of this study? 
The purpose of the study is to compare HI'! care and support delivered in your community by 
two different ways to the care that you would receive normally in the clinic. The two 
community delivery methods that are being studied are an adherence club where you would be 
in a group of 20-25 patients receiving care in a club within this community or a program where 
you would receive care at your home. The other option is that you will continue receiving care 
in the clinic. 
In both the adherence club and home based ART delivery, you will receive adherence support, 
screening for symptoms and collect your medications rather than travelling to the clinic to collect 
the drugs. 
This is meant to reduce long waiting times at the clinic and also reduce the number of visits you 
make to the clinic every year to collect your medications. 
It will also allow the clinic to attend to patients who clinically unwell to be monitored closely. 
The models will be monitored closely by the Zambart research team to determine if it will be 
successful in retaining HIV patients in care and allow us to roll it out wide in all communities. 
What will happen during this study? 
For you to be part of this study, we will need to check if you: 
• 
Have been on ART for more than 6 months 
• 
Have an undetectable viral load 
• 
Have no underlying infections such as Tuberculosis (TB) etc 
• 
Have maintained your clinic visits in the last 12 months. 
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We will review your ART file to see what drug regimens you are and whether you live in this 
community. If you did not have a viral load done as part of your routine care, we will have the 
clinic staff collect blood from you to measure your viral load. Once we confirm that you are stable 
by meeting the above requirements, we will determine which community zone you are living in. 
if the community zone you are living in has an adherence club, you will be asked to join the club 
and if you are not willing to then you are free to continue receiving care at the local clinic. If your 
zone provides Home based ART service, you will be asked to join this model where HIV care will 
be provided in your home. If you are not willing to join this model you can continue receiving 
care at the clinic. If the zone you are living in has no clubs or home based delive~y, you will 
continue coming to the clinic for your care. In all these models we will ask you for your physical 
address and enter you in either a home ART register or club register which will be kept in this 
clinic. The research team will also look at your clinic records to determine if you are doing well 
whilst receiving most of the HIV care in your community and if you did have your 6 monthly 
laboratory tests as part of your care. 
What happens if I am in an Adherence club? 
If you belong to an adherence club, you will be asked to meet at a common venue in your 
community with other members of the club who are also receiving care at this clinic. You will be 
asked to meet once every 3 months and a trained community HIV provider {CHiP} who works 
within your community zone will visit your club and do the following: 
1. Screen you to determine if you have any symptoms 
2. Record your weight 
3. Adherence counseling 
4. Provide you with 3 monthly supplies of ARVs and Septrin 
During these meetings, you will also have an opportunity to discuss any concerns or problems in 
a private setting with the CHiP. 
A Clinic nurse will also accompany the CHiP during one or two meetings to provide support. 
The CHiP will also remind when to next go to the clinic for your laboratory tests as well clinical 
review by the health care worker. You will be required to visit the clinic every 6 months and 
during this clinical visit, the club meeting will take place in the clinic where we will provide you 
with adherence support, have the clinician review you and a nurse collects blood for your 
laboratory tests. We will also give you your 3 months supply of drugs that should last you until 
we meet you in 3 months' time at the next club meeting in the community. 
When you attend a clinic visit for your laboratory tests and clinical review every 6 months, the 
results will be entered in your clinic file and the CHiP will also give the results to you. 
If you are unwell or the CHiP discovers you have a symptom that requires medical attention, you 
will be referred to the clinic to be seen by a clinician who will then decide if you are healthy to 
continue receiving care at the club or should resume care at the clinic. 
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All the information collected during the club visit will be entered in an electronic tablet. The 
information collected will then be entered into the clinic register and your care card at the clinic. 
The information provided during the meetings will also be used to determine if you will be 
clinically stable at the end of the study and also if the model works. These results are important 
to determine if you will be adherent and help us to roll these clubs in other communities in 
Zambia. 
At the end of the study, which is after 2 years, we will then refer you back to the clinic where you 
will continue your care. 
What happens if I am in a Home Based ART delivery model? 
If you belong to a zone where home based ART delivery will be provided, we will ask you for your 
physical address and a CHiP team that works in your community zone will visit you once every 3 
months to do the following: 
1. Screen you to determine if you have any symptoms 
2. Record your 'Neight 
3. Adherence counseling 
4. Provide you with 3 monthly supplies of ARVs and Septrin 
During these home visits, you will also have an opportunity to discuss any concerns or problems 
in a private setting with the CHiP. 
A Clinic nurse will also accompany the CHiP during one or two meetings to provide support. 
The CHiP will also remind when to next go to the clinic for your laboratory tests as well clinical 
review by the health care worker. This will be every 6 months where you will come to the clinic. 
We will discuss the best date and time for you to go to the clinic so that you can be quickly seen 
by the clinician and nurse who will collect blood for laboratory tests. During this visit, we will also 
provide you with adherence counselling and a 3 month supply of drugs that will last you until the 
next home visit. 
When you attend a clinic visit for your laboratory tests and clinical review every 6 months, the 
results will be entered in your clinic file and the CHiP will also give the results to you. 
If you are unwell or the CHiP discovers you have a symptom that requires medical attention, you 
will be referred to the clinic to be seen by a clinician who will then decide if you are healthy to 
continue receiving care at home or should resume care at the clinic. · 
All the information collected during the home visit will be entered in an electronic tablet. The 
information collected will then be entered into the clinic register and your care card at the clinic., 
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The information provided during the home visits will also be used to determine if you will be 
clinically stable at the end of the study and also if this type of model works. These results are 
important to determine if you will be adherent and help us to roll out this type of service in other 
communities in Zambia. 
At the end of the study that is after 2 years, we will then refer you back to the clinic where you 
will continue your care. 
What if I am not in a club or home based ART model? 
If you live in a zone that has no adherence club or home ART delivery services, you will continue 
receiving care at your local clinic like you have always done. The fact that you will be receiving 
care at the clinic will help us understand whether continuing receiving care in the clinic is better 
than the two models we are offering. Even if you continue receiving care at the clinic you will still 
be part of the study as we will monitor you at the local clinic and use the clinic data to determine 
if your care is no different from the other two models. 
Regardless of whichever models of care you are in, you may be selected to participate in a set in-
depth interviews and a focus group discussion that will be conducted by a group of social scientists 
from Zambart. The interviews will be held 4 times during the duration of the study while the focus 
group discussion will be held once. You are free not to participate in these interviews and focus 
group discussions if you are selected. If you choose not to participate in the interviews or focus 
groups, will still be allowed to remain in the study and to remain in the model of care you 
participate in. 
What are the potential benefits? 
There are no direct clinical benefits as a result of participating in the study. However: If you chose 
to participate in any of the two ART delivery models, it could reduce the amount oftime you have 
to spend at the clinic. When you are referred to the clinic, you will be received and fast tracked 
through the queues. 
Belonging to these types of models will provide a safe venue with whom you can share and get 
emotional support. When attending the clinic for a clinical review and laboratory tests, you will 
not need to queue up for drugs as this will be given to you at the club or at home. 
What are the possible risks or discomforts? 
There are no foreseen risks to being part of the additional study. However, if there were a breach 
of confidentiality, there is a risk that someone could learn of your status or other personal 
information. The study team will do everything to ensure confidentiality is maintained and the 
staffs who will be running these models of care are trained in maintaining confidentiality. 
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Adherence Clubs - if you are part of an adherence club, it would mean that other members of the 
club know that you are on ART. The other members in the club will also be from the same clinic 
that you have been receiving HIV care from. All members of the club should be able and willing 
to sign a "club charter of rights and responsibilities" in the presence of all club members, which 
include commitment to maintaining confidentiality. You will need to respect for one another's 
privacy during and after the club meetings - i.e. don't talk outside the group, ever, about who is 
in the group and their personal information. Should a member be found to breach this, s/he will 
be disqualified from the club and returned to mainstream care. 
Home-Based Visits - there is a possibility that family, friends and people in your community may 
find out that you are participating in health related study if they see the CHiPs coming to your 
home and you may experience stigma but we will do everything we can to protect your privacy. 
During home-visits, everything discussed between your and the CHiPs wiii be done in private. 
In both of these models you may end up feeling embarrassed or anxious when sensitive questions 
are being asked. You are free to skip questions you may deem personal or otherwise. 
What are my responsibilities? 
!f you chose to participate in this study, you are a·grccing to share the data or information 
captured with the clinic staff and researchers who will use the results to see if this type of service 
is ideal for stable patients. 
If you choose to participate, you are agreeing to be responsible for visiting the clinic ONCE every 
6 months. However, the CHiP will provide you with the date of the clinic visit and also remind you 
of the appointment. 
You are also agreeing to ensure that you receive your drug supply during these home visits and 
sign off an appropriate form that you have received the drugs. 
How will my confidentiality and privacy be protected? 
The only people who have access to the information you have provided during these meetings 
are the clinic staff and Zambart researchers conducting this study. 
People who may review the study records include: Biomedical Research Ethics Committee, local 
regulatory agencies, US National Institutes of Health (NIH), study staff, and study monitors. 
Institutional Review Boards (IRBs) or Ethics Committees (ECs) are committees that watch over 
the safety and rights of research participants. Provincial and/or national public health officials 
may be given community-wide results but not individual results 
What are some reasons why I may be withdrawn from this activity without my consent? 
You may be withdrawn from the study without your consent if the research study, or part of this 
study, is stopped or cancelled. 
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What happens if I am injured by participating in this study? 
It is very unlikely that you could be injured as a result of participating in this study. However, if 
you are injured while participating in this study, you will be given immediate treatment for your 
injuries. You will not have to pay for this care. There is no program for compensation either 
through this institution or the United States NIH. You will not be giving up any of your legal rights 
by signing this Subject Information and Consent Form. 
Persons to Contact for Problems or Questions 
If you have any questions about your participation in this research study, your rights as a research 
Participant, or if you feel that you have experienced a research-related injury, contact: 
Site Research Staff: DR MOHAMMED LIMBADA 
Research Site Address (es): ZAM BART Project, School of Medicine, Ridgeway campus, 
P.O. Box 50697, Lusaka, Zambia. 
Daytime Telephone Number (s): +260 211254710 
Email: Mohammed@zambart.org.zm 
If you have any questions or concerns about your rights as a research Participant or want to 
discuss a problem, get information or offer input, you may contact: 
Independent Review Board/Ethics Committee: Biomedical Research Ethics Committee 
Address of Independent Review Board: School of Medicine, Ridgeway campus, P.O. Box 
50110, Lusaka, Zambia 
Daytime Telephone Number:+ 260 211-256067 
Thank you for reading this information sheet. If you have any questions, please ask them now. 
If you have either read or have heard the information in this Participant Information and 
Consent Form, if all of your questions have been answered, and if you agree to take part in the 
study, please print and sign your name and write the date on the line below. 
Participant1s Name (print) 
Participant's Signature (or fingerprint) 
Date:~~~~~~~~~~~~ 
I certify that the information provided was given in a language that was understandable to the 
participant. 
-!*1; 
B:!ill!IBilJB:!ill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBill!IBillmli~" · "l!M 
.MVliNii 
COMMUNITY ART PROTOCOL V. 1.0 
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Name of Study Staff 
Conducting Consent Discussion (print) 
Witness' Name (print) 
(As appropriate) 
COMMUNITY ART PROTOCOL V. 1.0 
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Study Staff Signature 
Witness' Signature and Date 
44 

Appendix II. 
INFORMATION SHEET AND INFORMED CONSENT FORM FOR QUALITATIVE 
STUDY PARTICIPANTS. 
A Comparison of Different Community Models of ART Delivery amongst Stable HIV+ 
Patients in Two Urban Settings in Zambia". 
You are invited to take part in this research study because you are a health care worker, a 
Community HIV Provider {CHiP) or a person taking part in the community models of ART delivery at 
your health facility. Please ask the study staff to explain any words or procedures that you do not 
clearly understand. 
This form is called a Participant's Information and Consent Form. The purpose of this form is to give 
you information about the research study you are being asked to take part in. The form describes 
the purpose, procedures, benefits, and risks of the research study. You may choose not to join the 
research project or withdraw from this study at any time. If you choose not to take part in this study, 
it will not in any way affect your employment, participation in community models of ART delivery or 
access to health care. Please read this Participant's Information and Consent Form and ask as many 
questions as needed. You should not sign this form if you have any questions that have not been 
answered to your satisfaction. If you sign this form, you will be giving your agreement to take part 
in the study. 
There are several key points that you should be aware of before signing the consent form. 
These key points have been separated into sections under bold headings below. 
What will happen during this study and why am I being asked to take part? 
Zambart is conducting a study on two different community models {adherence clubs and home 
delivery model) of delivering ART services in your community. The purpose of this study is to 
compare whether people who are participating in these community models will have better health 
outcomes at the end of the study compared to others who are accessing treatment from the health 
facility. Understanding how health staff {including CHiPs) and people living with HIV who are on 
treatment experience the two models of care will help us interpret the results of this study better. 
Because you are either a health worker or a patient receiving ART, we would like to know your 
experience with these models of care by having you participate in a Focus Group Discussion or 
Individual Interview. If you agree to participate in a Focus Group Discussion, you will be put in a 
group of 8-10 people and two researchers from Zambart social science will we will discuss with the 
whole group a number of question related to how you or other people in the community have 
experienced the two models of ART. If you agree to participate in an Individual Interview on the 
other hand, you will have a one on one discussion with one researcher from Zambart social science 
who will ask you a number of questions related to how you experience the two models of ART. The 
focus group discussions (FGDS) and in-depth inter views {IDls) will be conducted once 18 months 
into the intervention. 
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What are the possible risks or discomforts? 
Some of the questions that we will ask you will be of a sensitive nature. You may become 
embarrassed, worried or anxious when asked questions about HIV, sexual risk behavior and other 
topics. Should this occur, or if you are otherwise upset by the study, the research staff can refer you 
to an appropriately trained person in this area for assistance. 
Another possible risk of participating in this study may be the loss of confidentiality of the 
information you give as it may find its way to people you work with or people in the community may 
hear of what you will tell us. 
Your participation is voluntary 
You do not have to be part of this study. Taking part in this study is your own decision. If you feel 
you have been forced or unfairiy pressured into participating either by us (the research team) or by 
your employer or line manager, then you are welcome to decline to participate now and this will 
not affect your employment, or care you receive at the health care facility or your ability to continue 
participating in the main study or community model of ART. If you decide today to take part in this 
research project, you may refuse to take part in any portion of the study or stop at any time and 
that also will not affect your employment, healthcare or main study participation or ART delivery. 
Who is doing the Study? 
Social science researchers from the Zambia AIDS Related Tuberculosis (Zambart) Project and the 
London School of Hygiene and Tropical Medicine (LSHTM} and partners including Imperial College 
London, will work closely on this study with colleagues from the HIV Prevention Trials Network 
{HPTN}. 
What are the potential benefits? 
There are no direct benefits associated with participation in the group discussions or individual 
interviews, but there may be indirect benefits for your community in the future. The information 
gained from this study may help organizations to design future intervention and programs that will 
help improve ART service delivery. This is also another benefit for policy-makers and intervention 
implementers to understand the impact of these models on service delivery as well as access to HIV 
services. 
Are there any alternatives to participation? 
There may be other studies going on here or in the community that you may be eligible for. If you 
wish, we will tell you about other studies we know about. You also have an alternative of not 
participating in this study. 
How will my confidentiality and privacy be protected? 
Confidentiality means we (the research team) will protect your identity and take steps to make sure 
that all the information you provide is separated from your identity {name, address, phone number 
COMMUNITY ART PROTOCOL V. 1.0 
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or any audio recording) as a person. We do this so that someone reading one of our reports or seeing 
our presentations will not know your identity. 
However, we cannot guarantee absolute confidentiality but every effort will be made to protect 
your confidential information. For example, none of the information you give will be kept in the 
same place as your name or other personal identifiers. Your name and any other information that 
may identify you or your household will be kept confidential. Although we will record the interviews 
and focus groups with your permission the discussions, information will not be linked or traced back 
to you. Data collected using the audio recorder will be downloaded to password protected secure 
computers under the management of the HIV Prevention Trial Network -HPTN 071 {PopART) data 
team. When this discussion or interview is fully transcribed {written up}, the recordings will be 
destroyed and data will be checked and cleaned centrally so as to remove any identifiers. Any 
publication of this study will not mention your name or identify you personally. Your records 
however may be reviewed by the U.S. National Institute of Health, the US Office of Human Research 
Protection, and the Bio-medical Research Ethics Committee from the University of Zambia, HIV 
Prevention Trial Network personnel, study staff, monitors and others who are responsible for the 
conduct of safety for this study. 
However, if we identify any serious health or welfare problems during the course of this research, 
we are obligated to refer you to others who are trained to help and will still keep all the information 
you will give about your problem confidential. 
What happens if I am injured by participating in this study? 
It is very unlikely that you could be injured as a result of participating in this study. Nothing that we 
will be asking of you will place you at risk of injury. However, if you are injured while participating 
in this study, you will be given immediate treatment for your injuries. You will not have to pay for 
this treatment. There is no program for compensation through the United States National Institutes 
of Health. However, in case of any research related injury, the London School of Hygiene and 
Tropical Medicine would provide compensation. You will not have to pay for this treatment. Social 
harms {that is, things like negative impacts on your employment or harassment by your neighbors, 
friends, or family due to participating in this study) are expected to be minimal, but if they occur, 
they will be monitored closely throughout the duration of the study. We encourage you to report 
any social harm that you experience, as and when they occur. If you do experience negative social 
harms every effort will be made by study staff to provide appropriate care and counselling to you, 
and/or to refer you to appropriate resources and care. 
You will not be giving up any of your legal rights by signing this Participant's Information and Consent 
Form. 
Costs to you 
There is no cost to you for being in this study. If you are taking part in a Focus group discussion or 
an interview, we try by all means to conduct the activity at your own convenient time and location 
in the community or at the health facility. All Focus Group Discussions will approximately be one 
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hour and thirty minutes while interviews will most likely be within an hour. Refreshments for both 
activities will be provided. 
What are some reasons why I may be withdrawn from this activity without my consent? 
You may be withdrawn from the study without your consent forthe following reasons: 
• 
The research study, or this part of the study, is stopped or cancelled 
• 
The study staff feels that completing the study or this part of the study would be harmful to you or 
others. 
• 
If you as a participant are unable or unwilling to participate in the study in a way that is in compliance 
with the necessary study procedures 
Persons to Contact for Problems or Questions 
If you have any questions about your participation in this research study, your rights as a research 
participant, or if you feel that you have experienced a research-related injury, contact: 
CONTACTS FOR QUESTIONS (Names, addresses and phone numbers of the following): 
1. Principal Investigator: Dr. MOHAMMED LIMBADA ZAMBART Project PO Box 50697, Ridgeway 
Campus, School of Medicine Lusaka.Telephone: +260 211254710 
Email: Mohammed@zambart.org.zm-
2. Co-Investigators: Bwalya Chiti, Dr. Virginia Bond, Dr. Helen Ayles, ZAM BART Project PO Box 50697, 
Ridgeway Campus, School of Medicine Lusaka. 
Telephon~: +260 211254710 
Chairperson, Bio-medical Research Ethics Committee, School of Medicine, Ridgeway Campus, 
University of Zambia, P.O. Box 50110, Lusaka, Zambia. 
Telephone: 260 211256067 
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INFORMED CONSENT FORM FOR HEALTH CARE WORKERS AND People Living with HIV 
QUALITATIVE STUDY PARTICIPANTS 
A comparison of different community models of ART delivery amongst stable HIV+ patients in 
two urban Setting in Zambia. 
1. I have been given sufficient time to consider whether to take part in this study. 
2. My taking part in this research study is voluntary. I may decide not to take part or to 
withdraw from the research study at any time without penalty or loss of benefits or 
treatment to which I am entitled. 
3. The research study may be stopped at any time without my consent. 
4. I have had an opportunity to ask the study staff questions about this research study. My 
questions so far have been answered to my satisfaction. 
5. I have been told how long I may be in the research study. 
6. 
I have been informed of the procedures that may be performed during the research study. 
7. 
I have been told what the possible risks and benefits are from taking part in this research 
study. I may not benefit if I take part in this research study. 
8. I do not give up my legal rights by signing this form. 
9. I have been told that before any study related procedures being performed, I will be asked 
to voluntarily sign this Participant Information and Consent Form. 
10. I will receive a signed and dated copy of this Participant Information and Consent Form. 
If you have either read or have heard the information in this Participant Information and Consent 
Form, if all of your questions have been answered, and if you agree to take part in the study, 
please print and sign your name and write the date on the line below. 
Participant's Name (print) 
Date: ~~~~~~~~~~~~-
COMMUNITY ART PROTOCOL V. 1.0 
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Participant's Signature (or fingerprint) 
49 

I certify that the information provided was given in a language that was understandable to the 
participant. 
Name of Study Staff 
Conducting Consent Discussion (print) 
Witness' Name (print} 
(As appropriate) 
COMMUNITY ART PROTOCOL V. 1.0 
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Study Staff Signature 
\\fitness' Signature and Date 
so 

Appendix Ill. Community ART Smart Care module for Stable ART Patients 
Registration: 
Last Name 
First Name 
Gender 
Date of Birth 
NRC 
Auxiliary ID (optional ... can be phone number, safe motherhood number or any other unique ID) 
1 Stable on Care 
1.1 
Health History 
Do you have a fever? [Yes] [No] 
Do you have Cough for more than 2 weeks? [Yes] [No] 
Are you losing weight? [Yes] [No] 
Do you have headache? [Yes] [No] 
1.2 Health Screening LMP (if female} 
1.2.1 Still Having menstrual periods? [Yes] [No] 
1.2.2 {If 1.2.1 is Yes) Last menstrual period [Enter date] 
1.2.3 {If 1.2.1 is No) Reason for not having menstrual period? 
[Pregnancy] 
[Menopause] 
[Premenarche] 
[Breast feeding] 
[Contraceptives] 
[Don't Know] 
1.3 Physical Exam (OPTIONAL -only by HCW conducting the visit} 
1.3.1 Blood Pressure [diastolic][systolic] ....... OPTIONAL 
1.3.2 Temperature [value] .............................. OPTIONAL 
1.3.3 Weight [value] ........................................ OPTIONAL 
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1.3.4 Urine Protein [Negative] [Trace] [+] [++] [+++] ................. OPTIONAL 
1.3.5 Urine Glucose [Negative] [Trace] [+] [++] [+++] ............... OPTIONAL 
1.4 Adherence Counselling 
1.4.1 Does the patient ever have trouble taking the pills? [Never] [Rarely] [Sometimes] [Often] 
[Very Often] 
1.4.2 Since the last visit has client missed more than 3 doses? [Yes] [No] 
1.4.3 Reasons for missing doses? [Forgot] [Felt Ill] [Away from home/travel] [Meds finished] 
1.5 Counseiiing Given 
1.5.1 Type of Counselling Given? 
[Adherence Counselling] 
[Safer sex] 
[Family planning] 
[Disclosure] 
[STl/TB counseiiing] 
[Partner testing] [Nutrition] 
1.6 Drugs Dispensed 
1.6.1 Pre-packed drugs dispensed to Patient? [Yes] [No] 
1.7 Next Appointment Date [value] 
1.8 Next Six Month Visit Date [value] 
1.9 Facility Referral 
1.9.1 Please select the Type of Referral 
[Partner Referral to Facility for ART] 
[Male Circumcision] 
[Family Planning] 
[HTC Appointment] 
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[ANC Appointment] 
[OPD] 
1.9.2 Specify Facility referred to 
2.7.2.1 Province [value] 
2. 7 .2.2 District [value] 
2.7.2.3 Facility [value] 
1.9.3 Appointment Date [value] 
1.10 Save 
1.10.1 Confirm Save [Yes] [No] 
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Appendix IV: INVESTIGATORS CVs 
CURRICULUM VITAE FOR MOHAMMED LIMBADA, BSc, MBCHB, MSclD 
Current Appointment: 
BSc 
MBCHB 
Msc 
COMMUNITY ART PROTOCOL V. 1.0 
10 JANUARY 2017 
Holds a Bachelor of Science, Human Biology and Bachelor of 
Medicine and Bachelor Surgery from the University of Zambia 
Has a MSc in Infectious Diseases from the London School of Hygiene 
and Tropical Medicine 
• 
Phylogenetic Study Manager under the HPTN 071 study 
• 
Population Cohort Coordinator HPTN071 
Human Biology, University of 
Zambia 
Bachelor of Medicine and Bachelor of 
Surgery, University of Zambia 
(Infectious Diseases) London School of 
Hygiene and Tropical Medicine 
Courses attended 
Good Clinical Practice (GCP), Responsible 
conduct of Research and Human subject 
protection- CITI 
Brown International Advanced Research 
Institute, Browns University, Providence, 
USA 
1995-1999 
2000-2002 
2011 
2013 
2012 
2007 
2007 
54 

Overview 
ASPIRE 
HIV/AIDS 
Professional 
Development Program-
San Francisco 
General Hospital, University of California. 
Clinical Training Skills -
Ministry of 
Health/JHPIEGO 
Management of Adult HIV/AIDS in 
Zambia. (John Hopkins Centre for Clinical 
Global Health education and JHPIEGO) 
Pediatric HIV Management -Trainer of 
trainers; MOH/Clinton Foundation 
Principles of STl/HIV -University of 
Washington, Seattle 
Trainer of Trainers Course (Adult HIV 
Management), Ministry of Health 
Management of Adult HIV Training 
Course, South- Africa Foundation of 
Professional Development (FPD), South 
African Medical Association 
The Care and Treatment of HIV- infected 
Children, Baylor College of Medicine-
Texas 
2007 
2006 
2006 
2005 
2005 
2003 
I have over 5 years' experience conducting research in the field of HIV/ AIDS in high burden settings. I have served 
as a local Principal investigator for the HPTN 063 Study and Investigator of records of a clinical study funded by 
EGPAF. 
Recently I have been part of the HPTN 071 intervention working group and Population Cohort 
group. I am currently the study manager of the HPTN 071 Phylogenetic study. 
My research interests focuses on finding novel approaches surrounding HIV prevention and 
treatment, including mother-to-child transmission and sexually transmitted infections. 
COMMUNITY ART PROTOCOL V. 1.0 
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Major Research Studies 
2014-current HPTN 071 and Phylogenetic Study 
Funder: NIH/Gates 
Role : Study Manager 
2011- 2014 
HPTN 063 
Funder:NIH/FHl360 
Role: Principle Investigator 
2009-2011 
Non - Virologic Methods to predict HIV infections among HIV-exposed infants less than 12 
weeks 
Funder: EGPAF 
Role: Investigator of Records 
Previous posts held 
2004-2005 
Senior House Officer - Menze Mission Hospital 
2002-2004 
Resident Doctor, University Teaching Hospital 
Other professional activities 
2007-2014 
Member, National ART 
Technical Working Group 
Presentations at Conferences 
2011 
Early Immunologic response and subsequent survival among malnourished adults receiving 
antiretroviral therapy in urban Lusaka. Croi 2011, Boston USA 
2012 
Retention in care among HIV infected patients in rural areas of Zambia - National ART update, 
Lusaka 
2013 
Clinical, Virologic and Pharmokinetic Response to Acyclovir among African women with Genital 
Ulcer Disease - National Research Conference, Lusaka, Zambia 
COMMUNITY ART PROTOCOL V. 1.0 
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Accepted Abstracts 
1. Chi BH, Limbada Ml, Giganti MJ, Li MS, Bweupe M, Musonda P, Bubala P, Mubiana-Mbewe M, Chintu NT, 
Bolton-Moore C, Stringer JS. Non-virologic algorithms for predicting HIV infection among HIV-exposed 
Infants less than 12 weeks of age.: http://www.ncbi.nlm.nih.gov/pubmed?term=22935865 
2. Koethe JR, Limbada Ml, Giganti MJ, Nyirenda CK, Mulenga L, Wester CW, Chi BH, Stringer JS.AIDS. Early 
immunologic response and subsequent survival among malnourished adults receiving antiretroviral 
therapy in Urban Zambia. 2010 Aug 24; 24(13): 2117-21. 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2919155/ 
3. Chi BH, Cantrell RA, Mwango A, Westfall AO, Mutale W, Limbada M, Mulenga LB, Vermund SH, Stringer JS. 
An empirical approach to defining loss to follow-up among patients enrolled in antiretroviral treatment 
programs. Am J Epidemiol. 2010Apr15; 171(8): 924-31. 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2850972/ 
4. Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey 
_!:, Wald A, Celum C. Clinical and virologic response to episodic acyclovir for genital ulcers among HIV-1 
seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-
controlled trial. Sex Transm Dis. 2012 Jan; 39(1): 21-4. 
http://www.ncbi.nlm.nih.gov/pubmed?term=22183840 
5. Koethe JR, Lukusa A, Giganti MJ, Chi BH, Nyirenda CK, Limbada M, Banda Y, Stringer JS. Association 
between Weight Gain and Clinical Outcomes among Malnourished Adults Initiating Antiretroviral Therapy 
in Lusaka, Zambia. PMID:19730111 [PubMed-as supplied by publisher] 
6. Chi BH, Giganti M, Mulenga PL, Limbada M, Reid SE, Mutale W, Stinger JS. CD4+ Response and 
Subsequent Risk of Death among Patients on Antiretroviral Therapy in Lusaka, Zambia. J Acquir Immune 
Defic Syndr. 2009 Sep 1; 52(1): 125-31. PMID: 19546812 [PubMed- indexed for MEDLINE. 
7. Goldman JD, Cantrell RA, Mulenga LB, Tambatamba BC, Reid SE, Levy JW, Limbada M, Taylor A, Saag MS, 
Vermund SH, Stringer JS, Chi BH. Simple adherence assessments to predict virologic failure among HIV-
infected adults with discordant immunologic and clinical responses to antiretroviral therapy. AIDS Res 
Hum Retroviruses. 2008 Aug; 24(8): 1031-5. PMID: 18724803 [PubMed-indexed for MEDLINE 
Peer Reviewed Publications 
8. Chi BH, Limbada Ml, Giganti MJ, Li MS, Bweupe M, Musonda P, Bubala P, Mubiana-Mbewe M, Chintu NT, 
Bolton-Moore C, Stringer JS. Non-virologic algorithms for predicting HIV infection among HIV-exposed 
Infants less than 12 weeks of age.: http://www.ncbi.nlm.nih.gov/pubmed?term=22935865 
COMMUNITY ART PROTOCOL V. 1.0 
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9. Koethe JR, limbada Ml, Glganti MJ, Nyirenda CK, Mulenga L, Wester CW, Chi BH, Stringer JS.AIDS. Eaily 
immunologic response and subsequent survival among malnourished adults receiving antiretroviral 
therapy in Urban Zambia. 2010 Aug 24; 24(13): 2117-21. 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2919155/ 
10. Chi BH, Cantrell RA, Mwango A, Westfall AO, Mutale W, limbada M, Mulenga LB, Vermund SH, Stringer jS. 
An empirical approach to defining loss to follow-up among patients enrolled in antiretroviral treatment 
programs. Am J Epidemiol. 2010 Apr 15; 171{8}: 924-31. 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2850972/ 
11. Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey 
1,, \Nald A, Celurn C. Clinical and viroiogic response to episodic acyclovir for genital ulcers among HiV-1 
seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-
controlled trial. Sex Transm Dis. 2012 Jan; 39{1}: 21-4. 
http://www.ncbi.nlm.nih.gov/pubmed?term=22183840 
12. Koethe JR, Lukusa A, Giganti MJ, Chi BH, Nyirenda CK, limbada M, Banda Y, Stringer JS. Association 
bet\"Jeen \Afeight Gain and Clinical Outcomes among ~v~alnourished Adults Initiating Antiretroviral Therapy 
in Lusaka, Zambia. PMID:19730111 [PubMed-as supplied by publisher] 
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BIOGRAPHICAL SKETCH 
Provide the following information for the Senior/key personnel and other significant contributors. 
Follow this format for each person. DO NOT EXCEED FIVE PAGES. 
NAME: Kwame Shanaube 
eRA COMMONS USER NAME (credential, e.g., agency login): NA 
POSITION TITLE: Site Coordinator-HPTN 071/PopART- Zambia 
EDUCATION/TRAINING {Begin with baccalaureate or other initial professional education, such 
as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as 
necessary.) 
DEGREE 
Completion 
FIELD OF STUDY 
INSTITUTION AND LOCATION 
(if applicable) 
Date 
MM/YYYY 
University of Zambia 
BScHB 
06/1988 
Bachelor of Human 
Biology 
University of Zambia 
MBChB 
07/1999 
Bachelor of Medicine & 
Bachelor of Surgery 
University of Witwatersrand, South 
MPH 
11/06 
Public Health 
Africa 
London School of Hygiene and Tropical 
PhD 
1/14 
TB/HIV Clinical 
Medicine 
epidemiology 
NOTE: The Biographical Sketch may not exceed five pages. Follow the formats and 
instructions below. 
A. Personal Statement 
I am a clinician with a Master's degree in Public Health and PhD in TB clinical epidemiology. I 
have worked in the field of TB and HIV for the past 12 years as a researcher. Having worked 
in TB/HIV public health research for the past 12 years my confidence has an investigator has 
enormously grown. I have managed four large studies; two of which are community 
randomized trials; other two have been operational research and I am currently Pl for an 
adolescent study looking at uptake and acceptability of Universal HIV testing and treatment 
(UTT). My experience has ranged from providing technical assistance to the ministry of health 
for the implementation, roll out and evaluation of integrated TB/HIV activities; conducting a 
tuberculin skin test surveys and designing mechanisms of follow up; designing and 
implementing monitoring and evaluation tools for household based integrated TB/HIV 
COMMUNITY ART PROTOCOL V. 1.0 
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interventions as well as evaluating Quantiferon TB- Gold priority research questions in a 
developing country. 
I am currently site coordinator for one of the largest HIV prevention trials, the HPTN 
071/PopART. I am hard working, result-oriented and extremely dedicated to my work. I have 
published papers in the international medical literature and several more are in preparation. 
Apart from leading multi-disciplinary teams, I have held key decision making responsibilities 
which included managing study finances. I have experience of working with international 
development program and extensive exposure to global health systems. I am involved in 
teaching Master of Science in Epidemiology students in the school of Public Health as well as 
mentoring them. 
My vision: To contribute towards efforts of improving the lives of individuals infected with TB 
and H!V at individual, family, and community levels; to promote strengthening of health 
systems in countries where TB and HIV is rampant. i believe I have a role to play to make the 
world a better place. 
B. Positions and Honor 
AWARDS 
• 
Study Manger for the "best overall performing team-Tuberculin skin test survey, 2009", 
Zambart 
• 
Scholarship by WHO to attend advanced Course on Diagnostics, 29th August to 2 September 
2011, France 
HONORS 
• 
Honorary lecturer- University of Zambia, School of medicine; 2014-date 
POSITIONS AND EMPLOYMENT 
• 
01/12-present 
• 
04/15-present 
• 
06/07-12/11 
• 
01/06-12/08 
• 
06/09-06/10 
• 
01/05-12/09 
• 
10/03-12/04 
• 
05/01-01/02 
• 
12/97-01/02 
Study Manager/ Site Coordinator, HPTN 071/PopART, Zambart, 
Lusaka Zambia 
Principal Investigator, Adolescent in HPTN 071/PopART study 
Study Manager, Quantiferon-TB GOLD Cohort, ZAMSTAR, Zambart, 
Lusaka Zambia 
TB prevalence survey Manager, copperbelt site ZAMSTAR, Zambart, 
Lusaka Zambia 
Monitoring and Evaluation Manager, ZAMSTAR, Zambart, Lusaka 
Zambia 
Tuberculin skin test survey manager, ZAMSTAR, Zambart, Lusaka 
Study Manager, Integrated TB/HIV activities (ProTEST}, Study 
Manager, Lusaka Zambia. 
Resident Doctor, St Johns Medical Center, Lusaka Zambia) 
Junior and Senior Medical officer, University Teaching Hospital (UTH), 
Lusaka, Zambia 
C. Contribution to Science 
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1. TB/HIV 
integration-
"ProTEST 
Project-
Zambia" 
The name "ProTEST" is derived from the "Promotion of voluntary HIV testing" as an entry 
point for access to the core interventions of intensified TB case-finding and isoniazid 
preventive treatment. The ProTEST initiative was established in 1997 by WHO to develop a 
more coherent response to TB in settings with high HIV prevalence through collaboration 
between TB and HIV/AIDS control programmes. HIV counselling and testing services were 
developed as the entry point to a package of prevention, care and support services. This 
paved the way for large-scale operationalization of the comprehensive range of interventions 
needed to control TB in settings with high HIV prevalence. My specific role in this initiative 
was that of study manager and I spearheaded the provision of technical assistance to the 
Ministry of Health; was involved in national roll out of collaborative TB/HIV activities and 
pioneered strategies to bring TB & HIV programmes together- now the basis of international 
policy-WHO framework for TB/HIV collaborative activities. To test whether TB/HIV 
integration, including community level implementation combined with enhanced case finding 
for TB, can impact the TB epidemic at community level we conducted the ZAMSTAR trial of 
which my roles were as follows: study manager for the tuberculin skin test survey and TB 
prevalence survey; in charge of monitoring and evaluation of the intervention. The ZAM STAR 
trial has informed the implementation of community level HIV/TB integration and also the 
role of TB case finding which both have been included in WHO policies. 
Published papers/reports 
1. Ayles H, Muyoyeta M, Du Tait E, Schaap A, Floyd S, Simwinga M, Shanaube K, Chishinga 
N, Bond V, Dunbar R, De Haas P, James A, Gey van Pittius NC, Claassens M, Fielding K, 
Fenty J, Sismanidis C, Hayes RJ, Beyers N, Godfrey-Faussett P. Effect of household and 
community interventions on the burden of tuberculosis in southern Africa: the 
ZAMSTAR community-randomised trial. Lancet. 2013 Oct 5; 382(9899):1183-94. 
2. Report of a Lesson's Learnt Workshop on the 6 Pro TEST pilot projects in Malawi, South 
Africa and Zambia 3-6 Feb 2004. WHO 2004. WHO/HTM/TB/2004.336 
Presentations I have made at international meetings and conferences 
1. 42nd UNION conference on Lung Health, Lille, France, "Impact of ZAMSTAR 
interventions on transmission of tuberculosis", 30th October 2011. 
2. Global TB/HIV working group on the stop TB Partnership; "Integration of TB/HIV with 
PMTCT: field experience from Zambia", Toronto, August 2006 
3. TSRU meeting," ProTEST expansion in Zambia", Geneva, April 2004 
4. 35th Union World Conference on Lung Health, Paris," ProTEST expansion in Zambia" 
October 2004 
5. WHO meeting "Scaling up TB/HIV collaborative activities in Zambia", Ethiopia, 2004 
2. TB diagnostics 
I have contributed to the TB diagnostics knowledge gaps in testing new tools for TB 
infection and disease (see other sections for details) as well HIV self-testing tools in a 
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resource limited setting. I was part of a team that pilot tested the feasibility and uptake of 
HIV self-testing using OraQuick® ADVANCE in a resource limited setting. In addition in line 
with WHO policy, I have been involved in field testing and ministry of health 
implementation and roll-out of gene Xpert. 
Published papers 
1. Dalila Zachary, Lawrence Mwenge, Monde Muyoyeta, Kwame Shanaube, Albertus 
Schaap, Virginia Bond, Barry Kosloff, Petra de Haas, Helen Ayles. Field comparison of 
OraQuick® ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV 
antibody tests in Zambia; July 2012. 
3. Diagnosis of latent tuberculous infection and use of tools to predict disease in HIV infected 
populations 
Tuberculin skin test (TST) has been traditionally used to identify tuberculous infected 
individuals; however, its use is limited by several factors. QuantiFERON-TB Gold In-Tube {QFT-
GIT} provide an alternative to TST and its use is included in the guidelines of many countries 
in low TB incidence settings although its use in high-burden settings remains unclear. This led 
to my PhD training at the LSHT~v~ in TB/HIV clinical epidemiology funded by Fl~JD vvhich 
focused on the use of IGRAs within prospective, large scale studies of households exposed to 
tuberculosis and to determine whether they would be used to predict individuals most likely 
to develop disease. This study also served as a pilot field demonstration study comparing the 
performance and operational characteristics of QFT-GIT and TST in a resource limited setting 
with a high prevalence of TB and HIV. My specific role was that of study manager and Co-Pl. 
Findings from this study contributed towards the formulation of WHO policy which 
recommended that neither lGRAs nor the TST should be used in low- and middle-income 
countries for the identification of individuals at risk of developing active TB. 
Published papers 
1. WHO. Use of interferon-gamma release assays (IGRAs) in TB control in low- and middle-
income 
settings. 
2011. 
Expert 
Group 
Meeting 
Report 
20-21 
July 
2010; 
WHO/HTM/TB/2011.17 
2. Shanaube K, Hargreaves J, Fielding K, Schaap A, Lawrence K-A, Hensen B, et al. Risk Factors 
Associated with Positive QuantiFERON-TB Gold In-Tube and Tuberculin Skin Tests Results 
in Zambia and South Africa. PLoS ONE. 2011;6(4):e18206 
3. Shanaube K, De Haas P, Schaap A, Moyo M, Kosloff B, et al. (2010). "Intra-assay Reliability 
and Robustness of QuantiFERON-TB Gold In-Tube Test in Zambia." Int J Tuberc Lung Dis 
14: 828 - 833. 
4. Shanaube K, Sismanidis C, Ayles H, Beyers N, Schaap A, Lawrence K-A, et al. Annual Risk of 
Tuberculous Infection Using Different Methods in Communities with a High Prevalence of 
TB and HIV in Zambia and South Africa. PLoS ONE. 2009;4(11):e7749. 
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Presentations I have made at international meetings and conferences 
1. UNION meeting, CDC late breaker session, Berlin, "Prognostic value of Quantiferon-TB 
Gold test in household contacts in Zambia and South Africa", Nov 2010 
2. 
CREATE meeting, "QuantiFERON-TB Gold responses in TB patients and contacts" Cape 
town, Sept 2009 
3. 4th National Health Research Conference, "Tuberculin Skin Test Survey in Zambia and 
South Africa"; Lusaka; January 2007 
4. HPTN 071/PopART study 
The Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) study 
is based on the principle of evaluating UTT using operational research within existing 
systems. PopART (HPTN 071) is a research study that aims to determine the impact of a 
package of HIV prevention interventions on community-level HIV incidence. My specific role 
in this study is that of PopART study manager include involves provision of technical and 
administrative leadership for a large multi-disciplinary team; development of the study 
protocol and other priority research questions; designing intervention and research SOPs as 
well as spearheading training and implementation; working in close cooperation with the 
PEPFAR implementing agencies, CDC and USAID, and other stakeholders in the preparation, 
implementation, monitoring and evaluation of the study and managing study budget 
resources. Although the study is currently ongoing implementation lessons learnt so far 
especially on the feasibility of rolling out UTT have been invaluable to policy makers, other 
health professionals and international policy. 
Published papers 
1. Shanaube K, Bock P. Innovative Strategies for Scale up of Effective Combination HIV 
Prevention Interventions in Sub-Saharan Africa. Curr HIV/AIDS Rep. 2015;12(2):231-7. 
2. 
Hayes R, Ayles H, Beyers N, Sabapathy K, Floyd S, Shanaube K, et al. HPTN 071 
(PopART): Rationale and design of a cluster-randomised trial ofthe population impact 
of an HIV combination prevention intervention including universal testing and 
treatment - a study protocol for a cluster randomised trial. Trials. 2014;15 (1):57. 
Presentations I have made at international meetings and conferences 
1. HPTN Annual Meeting, "Overview of PopART intervention", June 2014, Lusaka, Zambia. 
2. INTEREST Meeting, "Overview of the PopART study", May 2014, Lusaka, Zambia 
3. East and Southern Regional Consultation on the Strategic use of ARVs, "An overview of 
the PopART study" Harare, Zimbabwe, March 2013. 
D. Research Support 
1. Uptake and acceptability of a combination HIV prevention package among young 
people in Zambia and South Africa (Adolescents in PopART) the nested study will be a 
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community randomized comparison of a combination prevention approach, combined 
with youth targeted interventions where necessary, in adolescents aged 15-20 years. 
Roles: Principal Investigator 
Date: 2015-2018 
Funding: DFID and SIDA as part of the EPHSA research funds- Contract in process 2. 
2. PopART/HPTN 071 Population Impact of antiretroviral therapy to reduce HIV 
transmission 
Role: Study Manager 
Dates: 2011-2018 
Funding: N!H/NIAID/BMGF/NIMH/NIDA $70,000,000, OGAC funding for 
implementation $57,000,000 (Total being directly managed through Zambart 
$36,500,000) 
Completed Research Support 
1. ZAMSTAR: Community randomised trial of two interventions to reduce the prevalence of 
tuberculosis at community level 
Role: Tuberculin skin test survey manager/TB survey Prevalence managers for Copperbelt sites 
Dates: 2004-2014 
Funding: Bill and Melinda Gates Foundation via CREATE consortium $30,000,000 of which 
$13,150,995 was managed by Zambart 
2. Quantiferon Gold In Tube for diagnosis of M. tuberculosis infection demonstration 
project and cohort study 
Dates: 2007-2010 
Role: Study Manager 
Funding: Work was supported by the Foundation for Innovative New Diagnostics 
(FIND). Further support was provided by a subcontract from Johns Hopkins University 
with funds provided (Grant No. 19790.01) from the Bill and Melinda Gates Foundation 
via the CREATE (Consortium to Respond Effectively to AIDS and Tuberculosis Epidemic) 
consortium. 
4. Promotion of voluntary Testing as an entry point for access to the core interventions 
of intensified TB case-finding and isoniazid preventive treatment. 
Role: ProTEST study manager 
Dates: 2001-2004 
Funding: WHO 
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1. Surname: Simwinga 
Nationality: Zambian 
First name (s): Musonda 
Sex: Male 
2. Contact Details: Musonda Simwinga 
C/o Zambia AIDS Related Project. University of Zambia School of Medicine, Ridgeway 
Campus: P.O. Box 50697, Lusaka, Zambia. Email: musonda@zambart.org.zm, 
musondasimwinga@yahoo.co.uk 
3. Summary 
I hold a Bachelor of Arts (BA}, Master of Arts (MA) and I recently obtained a research 
degree PhD from the London School of Hygiene and Tropical Medicine (LHTM}. I have 10 
years' experience conducting research in TB and HIV in high burden settings using mixed 
methods approaches. My previous experience was in managing development and 
HIV I AIDS oriented projects including Monitoring and Evaluation. Recently, my research 
interests have been to assess and develop better ways of engaging the community in 
research. I have been involved in various studies including the ZAMSTAR study, a large two 
country randomised control trial of community level interventions aimed at reducing the 
burden of TB and HIV.As an employee of the ZAM BART Project, I has been instrumental in 
building capacity for all research staff in conducting ethical research through facilitating 
research ethics as well as Good Clinical Practice (GCP) training. 
4. Degree(s) (subjects1 university or schoo/1 year) 
• 2015: PhD (research degree) with the London School of Hygiene and Tropical Medicines 
• 2007: Research Ethics fellowship with Fogarty African Bioethics Training Programme 
attainable at John Hopkins University 
• 1996-1997: Master in Policy Studies with Fort Hare University 
• 1989-1993: Bachelor of Arts degree with the University of Zambia 
s. Posts held (type of post1 lnstitution/Faculty/department1 date for the Last 10 '{.ears) 
• 
200-2004: Field Operations Manager and the Microcredit and Income Generation Manager 
for the Microprojects Unit (MPU} which was the largest EU funded project in the country 
• 
May-2004 November 2004 : Monitoring and Evaluation office/ Social scientist for the 
Microbicide Development Programme (MDP} Zambia 
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• 
December 2004-Aprii 2005: Monitoring and Evaluation Manager and Acting Programme 
Manager for the Reaching HIV/AIDS Affected People with Integrated Development and 
Support (RAPIDS} programme funded through PEPFAR 
• 
May 2005 to 2011: Study Manager for the Zambia and South Africa TB and AIDS Reduction 
(ZAMSTAR} in Zambia. ZAMSTAR was a large multi-country randomized trial of 2 innovative 
interventions to reduce the burden of TB and HIV at community level. The study covered a 
population of approximately 1.2million people in Zambia and South Africa in 24 
communities (16 ZA, 8 SA). 
• 
December 2011 to date: Community Engagement Manager 
4. Publications 
1. Simwinga, M. and C. Kabero, Community Engagement in Research Ethics in Africa: A 
Resource for Research Ethics Committees, M. Krugger, P. Ndebele, and L. Horn, Editors. 
2014, Sun Press: South Africa. 
2. Nancy E. Kass, Andrea N. Deluca, Leonie Coetzee, Musonda Simwinga, et al., Applying 
Ethical Principles to International Community-Based Research: A Case Study from the 
Consortium to Respond Effectively to the AIDS-TB Epidemic {CREATE}. !RB: Ethics & Human 
J 
Research, 2014. 36(3) 
I 
3. Ayles H, !V!uyoyeta !VI, Du Toit E, Schaap A, Floyd S, Simwinga !VI, Shanaube K, Chlshinga N, 
Bond V, Dunbar R, De Haas P, James A, Gey van Pittius NC, Claassens M, Fielding K, Fenty J, 
Sismanidis C, Hayes RJ, Beyers N, Godfrey-Faussett P; ZAMSTAR team, Effect of household 
and community interventions on the burden of tuberculosis in southern Africa: the 
ZAMSTAR community-randomised trial. Lancet. 2013 Oct 5;382(9899):1183-94. doi: 
10.1016/S0140-6736(13}61131-9. Epub 2013 Aug 1 
4. Bond V, Chilikwela L, Simwinga M, et al., Children's role in enhanced case finding in Zambia. 
lntJ Tuberc Lung Dis 2010. Oct: 14(10): p. 1280-7. 
5. Boccia D, Hargreaves J, Simwinga M, et al., Tuberculosis infection in Zambia: the 
association with relative wealth. Am J Trap Med Hyg., 2009. Jun; 80(6): p. 1004-11. 
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LAWRENCE MWENGE 
P.O. Box 50697, Ridgeway, 
Lusaka, Zambia 
E-mails: lawrence@zambart.org.zm 
Phones: +260 211 254710 
PROFILE: HEALTH ECONOMIST 
I'm an enthusiastic, adaptive and fast-learning economist with an acute interest and experience 
in health economics and health systems research. My major areas of interest are health care 
financing, economic evaluation and health policy analysis. 
Specialties: Economic analysis, cost tracking, Policy analysis, project management, and 
econometrics and modelling, Project Appraisal, health systems research and health care 
evaluation. 
PROFESSIONAL EXPERIENCE 
Zambia AIDS Related TB (ZAMBART) Project, Zambia, 2006-present, Health Economist 
Main Roles: 
• Lead Health Economist; Managing and coordinating all health economks projects, 2014-
present. 
• Principle investigator on Economic Evaluation of the Better Health Outcomes through 
Mentoring and Assessment (BHOMA) interventions, Zambia, 2010-2014. 
• Assistant Programme manager; Community TB case finding Programme, 2009-2011. 
• Co-Principle investigator on Economic Evaluation of the Zambia South Africa TB and AIDS 
Reduction (ZAMSTAR) community randomized Trial, Zambia and South Africa, 2006-2010. 
• Co-Principle investigator on Economic Evaluation of TB diagnostics; solid .and liquid TB 
culture, Zambia, 2006-2007. 
Consultancy Work 
• 
Institution of Medic.al Research and Training (IMReT); Zambia, 2013-present, Health 
Economics Consultant (Co-principal Investigator). 
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• 
London School of Hygiene & Tropical Medicine (LSHTM); Health Economics Consultant 
on economic evaluation of eye health services in Zambia, 2011. 
• 
AIDS Alliance; Health Economics Consultant on cost analysis of Home-based care services 
in Zambia, 2008. 
EDUCATION 
2012 
MSc in Public Health, London School of Hygiene and Tropical Medicine; London, UK. 
Thesis title: The Cost of Eye Care Treatment from the Societal Perspective in Zambia. 
2006 
BSc in Agricultural Economics, University of Zambia; Lusaka, Zambia. 
1997 
School Certificate ('O' level), Mungwi Technical Secondary School; Mungwi, Zambia. 
SKILLS TRAINING WORKSHOPS 
2012: Evaluating the costs of public health interventions: A short-course in applied economic 
evaluation organised by Boston University and University of Zambia; Lusaka, Zambia. 
2011: Health Care Evaluation, London School of Hygiene & Tropical Medicine; London, UK. 
2009: Economic Evaluation of health care, London School of Hygiene & Tropical Medicine; 
London, UK. 
AWARDS 
2009 Commonwealth scholarship for distance learning studies to pursue a Master's of Science 
(MSc) course in Public Health with London School of Hygiene and Tropical Medicine, 
London, UK. 
1999 
Best Student award, Community Health workers Training organized by Ministry of Health 
& JICA at Chawama clinic; Lusaka, Zambia. 
1995 
Best Student award in Mathematics Olympiads organized by JICA at Mungwi Technical 
Secondary School; Mungwi District, Zambia. 
RESEARCH EXPERIENCE 
1. 
Investigator; HPTN 071 Population Effects of Antiretroviral Therapy to Reduce HIV 
Transmission (HPTN 071-PopART): A Cluster-Randomized Trial of the Impact of a 
Combination Prevention Package on Population-Level HIV Incidence in Zambia and South 
Africa, Zambart, 2013-2017. 
2. 
Consulting Economist; Economic Evaluation of Cryptococcus Meningitis at UTH, Lusaka 
Zambia, IMReT, 2012-2014. 
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3. 
Principle Investigator; Cost analysis of better health outcomes through mentoring and 
assessment {BHOMA} interventions, CIDRZ and Zambart, 2011-2014. 
4. 
Consulting Economist; Cost-effectiveness analysis of eye services in Zambia, LSHTM, 2011 
5. 
Co-Principle Investigator; A comparative economic evaluation of TB/HIV community 
randomized interventions in Zambia and South Africa, Zambart 2008 to 2009. 
6. 
Consulting Economist; Cost analysis of home-base care programmes in the era of 
antiretroviral therapy {HIV}: assessing the cost of providing home-based care services in 
Zambia from provider's perspective, AIDS Alliance, 2009. 
7. 
Health Economics Research Assistant; A comparative economic evaluation of MGIT and LJ TB 
culture techniques in Zambia. Lusaka, Zambia (published); Zambart 2007. 
8. 
Health Economics Research Assistant; assessing costs of tuberculosis {TB} diagnosis and 
treatment from the patient's PERSPECTIVE in Zambia. Lusaka, Zambia (published}, Zambart, 
2007. 
9. 
Student; Assessing the relationship between Migration and rural Agriculture in Mungwi 
district, UNZA, 2005 (BSc. Thesis}. 
CONFERENCE PRESENTATIONS 
1. Poster: Cost analysis of TB/HIV reduction models; Enhance Case Finding and Household 
interventions. 4pt World Conference on Lung health of the International Union Against 
Tuberculosis and Lung Disease, Cape Town, South Africa, November 2010. 
2. Paper: Cost Analysis of ZAMSTAR TB/HIV Reduction Models. CREATE Meeting; Cape Town; 
2009. 
3. 
Poster: cost-effectiveness analysis of TB culturing using solid media versus liquid media to 
diagnose TB in Zambia. 38th World Conference on Lung health of the International Union 
Against Tuberculosis and Lung Disease, Cape Town, South Africa, November 2007. 
4. Paper: why Satanism is linked to HIV testing and HIV prevention activities in Zambia (co-
presenter}, Lusaka, Zambia, 2005.Paper: HIV-related Stigma {Literature review). pt 
International Conference on HIV/AIDS conference, Dare salaam, Tanzania, 2004. 
6. 
Poster: Community Awareness Campaign and the Misconceptions surrounding HIV/TB. 13th 
International Conference on AIDS and STls in Africa, Nairobi, Kenya, 2003. 
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SELECTED PUBLICATIONS 
1. 
Ulla K Griffiths, Fiammetta M Bozzani, Adrian Gheorghe, Lawrence Mwenge, Clare 
Gilbert. Cost-effectiveness of Eye Care Services in Zambia. Cost Effectiveness and 
Resource Allocation 2014. 
2. 
D. Zachary, L. Mwenge, M. Muyoyeta, K. Shanaube, A. Schaap, V. Bond, B. Kosloff, P. 
de Haas, H. Ayles. Field comparison of OraQuick® ADVANCE Rapid HIV-1/2 antibody test 
and two blood-based rapid HIV antibody tests in Zambia. BMC Infectious Diseases 2012. 
3. 
M. Muyoyeta, P. E.W. de Haas, D.H. Mueller, P. D. van Heiden, L. Mwenge, A. Schaap, C. 
Kruger, N. C. Gey van Pittius, K. Lawrence, N. Beyers, P. Godfrey-Faussett, and H. Ayles. 
Evaluation of the Capilia TB assay for culture confirmation of Mycobacterium tuberculosis 
in Zambia and South Africa. J Clin Microbial. 2010 Aug 4. 
4. 
A. Aspler, D. Menzie, 0. Oxlade, J. Banda, L. Mwenge, P. Godfrey-Faussett, H. Ayles. Costs 
of tuberculosis diagnosis and treatment from the patient perspective in Lusaka, Zambia. 
!nt J Tuberc Lung Dis 2008. 
5. 
D.H. Mueller, L Mwenge, M. Muyoyeta, M.W. Muvwimi, R. Tembwe, R. McNerney, P. 
Godfrey-Faussett, H. Ayles. Costs and cost-effectiveness of tuberculosis cultures using 
solid media in a developing country. Int J Tuberc Lung Dis 2008. 
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CURRICULUM VITAE 
PERSONAL DETAILS 
·:· Name: James Mwanza 
·:· Sex: Male 
•!• Age: 38years 
•!• Tribe: Ngoni 
•!• Nationality: Zambian 
•!• Marital status: Married 
•!• Religion: Christian 
PERSONAL ATTIBUTES 
•!• Highly motivated individual. 
•!• Requires minimum supervision. 
•!• Ability to meet deadlines. 
•!• Able to work under extreme pressure. 
•!• Result oriented. 
ACADEMIC QUALIFICATIONS 
•!• 2015- Masters of clinical Pharmacy Degree 
(McPharm clin).university of Zambia. 
•!• 2005- Bachelors of Pharmacy Degree ( B. 
Pharm) University of Zambia 
•!• 2005- Certificate in pharmaceutical care, 
communication, 
counseling 
skills 
and 
health 
promotions. 
Robert 
Gordon 
University. 
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CONTACTS 
·:· Cell:+ 260 968 335460 
·:· Email : jamesmwanza@gmail.com 
: james@zambart.org.zm. 
·:· Postal add: C/O Zambart Project. P.O. 
Box 50697 Lusaka-Zambia 
SKILLS 
•!• Good 
communication 
skills; 
written, 
verbal and listening skills 
•!• Well-developed interpersonal skills and 
ability to interact with other staff 
•!• Good computer skills, especially Ms Excel, 
Ms PowerPoint and some Data Base 
knowledge 
PROFESSIONAL QUALIFICATIONS 
•!• 2011-2013-Various trainings in logistics 
management/supply 
chain 
for 
pharmaceuticals 
and 
laboratory 
commodities. MOH/JSI Inc. 
•!• June 2013-Training in basic financial 
management for public funds. ZSSIP 
•!• January, 2008- Certificate in Logistics for 
Health Commodities, Global Health e 
Leaning Centre, USAID 
71 

•!• 1996 -
Grade 12 General Certificate of 
Education, Exams Council of Zambia 
•!• 1992 - Grade 9 Junior Secondary School 
Leaving Exams. Examinations Council Of 
Zambia 
•!• 1990-Grade 
7 
School 
Examinations Council of Zambia. 
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Certificate 
•!• February, 
2008 
Certificate 
In 
Monitoring and Evaluation, Global e 
Leaning centre, USAID 
•!• February, 2007-Good Clinical Practice. 
(G.C.P)- Certificate in Human Subject 
Protection, Supported by DAIDS, USA. 
•!• June, 2005 - Certificate in Antiretroviral 
Therapy And Opportunistic Infections 
and Neoplasm Management, MOH I 
ZPCT 
•!• August 2005- Certificate in Tuberculosis 
Management, Drug use and Reporting. 
WHO/Ministry of Health 
72 

WORK EXPERIENCE AND RESPONSIBILITIES 
1. Zambart Project. 
Currently working as PHARMACIST OF RECORDS at Zambart Headquarters. 
2. Ministry Of Health- Pharmacist Logistics. 
~ Responsibilities 
Monitoring all the Logistics Management systems/supply chain avenues. 
Analyzing supply chain constraints and possibly coming up with long lasting solution for the 
continuous supply of commodities to the community 
Trainer of trainers in supply chain for EMLIP, ARV's, TB, Essential medicines and vaccines to facility 
in-charges and dispensers 
Validation of Fridges for cold chain storage 
Ensuring that Bulk storage facilities and product handling procedures comply with Good Ware 
Housing Practicing. 
Procurement Planning for Medical and surgical supplies 
Storage Control Procedure Management 
Training Pharmacy In charges in DILSAT. 
Liaisons officer between Ministry of Health and Zambia Revenue Authority-Nakonde Boarder. 
Monitoring of distribution Patterns of all supplies to various Health Centres 
Preparing orders for ARV,PMTCT and HIV test kits 
Vaccine management for Child immunization. 
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3. Zambia Emory-HIV Research Project ( ZEH RP) Ndola, ( 2007-2009} 
A USAID/ IAVI Funded Organization 
Position: Project Pharmacist (Pharmacist of Record) /Archivist. 
Responsibilities: 
1. Managing available resources in conformity with standards of good pharmacy practice and 
planning for expansion of pharmaceutical services. 
2. Management of study drug in the P.!.P study (Partners In Prevention) A phase II double blind 
study. Suppression of H.S.V type II using Acyclovir tablets to reduce HIV transmission. 
3. Management of study Vaccine/Placebo in the PAVE 100 vaccine trial. 
4. Management of storage conditions for study drugs, vaccines/placebos for various clinical 
trials. 
5. Inventory control for ail clinical trial drugs, medicines, surgical supplies and contraceptives 
6. Implementation of drug/vaccine related study protocols. 
7. Meeting pharmaceutical needs and requirements of l.A.V.1- sponsored clinical trials 
8. Establishing policies and procedures to ensure safe use of study products . 
9. 
Liason officer between Pharmaceutical Regulatory Authority ( PRA} of Zambia and the Project 
( Pharmacist of Records) 
10. Prudent management finances and asserts of the organizations 
11. Monitoring and evaluating the procurement and utilization systems and procedures for their 
effectiveness. 
4. Kasama General Hospital ( 2005-2007) 
Position: Pharmacy Manager 
Responsibilities: 
1. Dispensing of anti-retroviral drugs to patients 
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2. 
Forecasting health commodity requirement (essential drugs) for the hospital 
3. Procurement planning and pipeline monitoring and support for all essential drug security 
programs 
4. 
Participating in performance audits both at hospital and provincial level. 
5. Trainer of trainers in adherence counseling to ARV medication 
6. Monthly ordering of ARV's for the ministry of health and submitting monthly consumption 
reports. 
7. Using robust logistics management information systems (LMIS) to fuel activities that support 
essential drug security by focusing on, the four pillars of logistic management which are 
Forecast, Finance, Procurement and Delivery. 
8. Constant monitoring of inventories, usage rates of essential drugs at hospital, clinic and 
district levels of care. 
9. Ordering of essential drugs from the medical stores and submission of monthly consumption 
report 
10. Supervising the procurement of surplus medicines by hospital tender committees. 
11. Participating in Quantification Exercise at District/Hospital/ Provincial and National level for 
the planning of acquisition of essential drugs in the Ministry of Health 
12. Training other health staff on district integrated logistical self-assessment tools (DILSAT) to 
promote commodity security. 
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PROFESSIONAL MEMBERSHIP 
1. Health Professions Council of Zambia. 
2. Pharmaceutical Society of Zambia, 
3. Hospital Pharmacists Association of 
Zambia. 
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• 
REFEREES 
Dr Chiluba Mwila, PhD . 
Lecturer department of Pharmacy 
Email:mwilachiluba@gmail.com 
Cell: +260 969 314492. 
• 
Dr Ravi Paul.MD PhD. 
Consuitant Psychiatrist University 
Teaching Hospital. 
Email:ravipaul35@gmail.com. 
Cell: +260 976 744654. 
• 
Prof. Pierre Yassa.MD. 
Lecturer of Dermatology. 
Schooi of medicine, University of 
Zambia. 
Email:perets31@gmail.com. 
Cell: +260 972877667. 
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