Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
Phase: NA
Conditions: HIV/AIDS, Noncommunicable Diseases, Hypertension, Diabetes
Sponsor: Brown University

 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
Funding Agency: National Institute of Mental Health – Award #R01MH118075-01A1 
 
ClinicalTrials.gov Registration: NCT04417127 
 
Project Personnel  
Institution  
Role   
Omar Galárraga, PhD 
Brown University, Rhode Island USA 
Multiple Principal 
Investigator (Contact MPI) 
Becky Genberg, PhD 
Johns Hopkins University, Maryland USA 
Multiple Principal 
Investigator 
Juddy Wachira, PhD 
Moi University School of Medicine, Eldoret, 
Kenya 
Co-Investigator, Local PI 
Jamil Said, MBChB 
Moi University School of Medicine, Eldoret, 
Kenya 
Co-Investigator 
Sonak Pastakia, PhD, 
PharmD 
Purdue University College of Pharmacy 
Academic Model Providing Access to Healthcare, 
Eldoret, Kenya 
Co-Investigator 
Tina Tran, PharmD 
Temple University School of Pharmacy, 
Pennsylvania USA 
Academic Model Providing Access to Healthcare, 
Eldoret, Kenya 
Co-Investigator 
Suzanne Goodrich, MD 
Indiana University School of Medicine, Indiana 
USA 
Academic Model Providing Access to Healthcare, 
Eldoret, Kenya 
Co-Investigator 
Jon Steingrimsson, PhD 
Brown University, Rhode Island USA 
Co-Investigator 
Youjin Lee, PhD 
Brown University, Rhode Island USA 
Co-Investigator 
Raj Vedanthan, MD 
Icahn School of Medicine at Mount Sinai, New 
York USA 
Co-Investigator 
Joe Hogan, ScD 
Brown University, Rhode Island USA 
Co-Investigator 
Paula Braitstein, PhD 
Academic Model Providing Access to Healthcare, 
Eldoret, Kenya 
University of Toronto, Dalla Lana School of 
Public Health, Toronto, Canada 
Co-Investigator 
Catherine Kafu, MPH 
Academic Model Providing Access to Healthcare, 
Eldoret, Kenya 
Project Manager – Kenya 
Marta Wilson-Barthes, 
MSPH 
Brown University, Rhode Island USA 
Project Manager – USA 
Harambee: Integrated Community-Based HIV/NCD Care & 
Microfinance Groups in Kenya 
Overall Project Protocol  
Version Date: 20 November 2024 

 
2 
 
Table of Contents 
Summary ....................................................................................................................................................... 4 
Acronyms ...................................................................................................................................................... 7 
1. 
Introduction ........................................................................................................................................... 8 
1.1 
Background .................................................................................................................................. 8 
1.2 
Objectives and Rationale ............................................................................................................. 9 
Figure 1. Schema of the cluster randomized trial ....................................................................................... 10 
2. 
Overview of key activities during the cluster randomized trial .......................................................... 11 
3. 
Aim 1 RCT Methods: Participants, intervention, and outcomes ........................................................ 12 
3.1 
Study setting .............................................................................................................................. 12 
3.2 
Description of the intervention and trial arms ........................................................................... 12 
3.3 
Eligibility criteria ....................................................................................................................... 13 
3.3.1 
Inclusion criteria .................................................................................................................... 13 
3.3.2 
Exclusion criteria .................................................................................................................. 13 
3.4 
Outcomes and endpoints ............................................................................................................ 15 
3.4.1 
Sample size ............................................................................................................................ 17 
3.4.2 
Power calculation .................................................................................................................. 17 
4. 
Aim 1 RCT Methods: Enrollment ....................................................................................................... 17 
4.1 
Enrollment of microfinance group members ............................................................................. 17 
4.2 
Enrollment of patients receiving facility-based care and not engaged in microfinance  ........... 18 
4.3 
Recruitment and retention strategies ......................................................................................... 20 
5. 
Aim 1 RCT Methods: Randomization  ............................................................................................... 21 
6. 
Aim 1 RCT Methods: Intervention Delivery  ..................................................................................... 21 
6.1 Medication refills .............................................................................................................................. 22 
6.2 Point of care testing .......................................................................................................................... 22 
Figure 2. Harambee Study Clinical Flow (Study Arm A) ...................................................................... 23 
7. 
Aim 1 RCT Methods: Data collection, management, and analysis .................................................... 25 
7.1 
Data Collection .......................................................................................................................... 25 
7.1.1 
Baseline assessments ............................................................................................................. 26 
7.1.2 
Follow up assessments .......................................................................................................... 27 
7.1.3 
Fidelity monitoring ................................................................................................................ 27 
7.2 
Statistical analysis  .................................................................................................................... 27 
8. 
Aim 2: Mixed methods to assess mechanisms through which MF and community-based care affect 
patient outcomes ......................................................................................................................................... 28 

3 
8.1 
Study Population and recruitment ............................................................................................. 28 
8.1.1 
Inclusion criteria for trial participants: .................................................................................. 28 
8.1.2 
Inclusion criteria for key stakeholder and care providers: .................................................... 28 
8.2 
Aim 2 (mixed methods mediation analysis) procedures ............................................................ 28 
8.3 
Aim 2 statistical analyses .......................................................................................................... 29 
9.
Aim 3. Cost-effectiveness analysis ..................................................................................................... 29 
9.1 
Aim 3 procedures ...................................................................................................................... 29 
9.2 
Aim 3 statistical analyses .......................................................................................................... 30 
10. Protection of human subjects .............................................................................................................. 31 
10.1 
Risks to human subjects ............................................................................................................ 31 
10.1.1 
Adequacy of protection against risks ................................................................................ 31 
10.1.2 
Informed consent .............................................................................................................. 31 
10.1.3 
Maintaining privacy and avoiding stigmatization ............................................................. 32 
10.1.4 
Minimizing psychological discomfort .............................................................................. 32 
10.1.5 
Minimizing risk to due to venipuncture ............................................................................ 32 
10.2 
Data safety and monitoring plan ................................................................................................ 33 
10.3 
Potential benefits of the proposed research to the participants and others ................................ 33 
References ................................................................................................................................................... 34 
Appendix I: Adult Consent Form 1............................................................................................................. 38 
Appendix II: Adult Consent Form 2 ........................................................................................................... 50 
Appendix III. Survey assessment tool ......................................................................................................... 55 
Appendix IV. Microfinance data collection instruments ............................................................................ 81 
Appendix V: Adult Consent Form 3 ........................................................................................................... 91 
Appendix VI: KEY INFORMANT INTERVIEW GUIDE – PARTICIPANTS ........................................ 94 
Appendix VII: KEY INFORMANT INTERVIEW GUIDE – PROVIDERS ............................................. 96 
Appendix VIII: NCD screening protocol at study baseline (implemented in all microfinance groups 
(Study Arms A and B)) ............................................................................................................................... 99 
Addendum to the overall project protocol .................................................................................................. 100 

 
4 
 
Summary  
Title: 
Harambee: Integrated Community-Based HIV/NCD Care & Microfinance 
Groups in Kenya 
NIH Award Number: 
1R01MH118075-01A1 
Study Description: 
Sustained viral suppression remains a key challenge for HIV treatment and 
prevention. Barriers such as lack of convenient access and economic 
instability have a major impact on retention in care for persons living with 
HIV (PLWH). The aim of this project is to evaluate the extent to which 
integrated community-based HIV care with group microfinance affects 
retention in care and viral suppression among PLHIV in rural western 
Kenya. We will use a cluster randomized controlled intervention design to 
randomize at least 40 existing microfinance groups (with a majority of 
members who are living with HIV) to receive microfinance plus either (A) 
integrated community-based care, or (B) standard care. We will also recruit 
a matched control group (C), receiving standard care without participation 
in microfinance activities. The hypothesis is that integrated community-
based care, within group microfinance, will improve viral suppression and 
retention in care compared to microfinance with standard of care and to 
standard of care alone. We will use qualitative and quantitative mediation 
analysis to evaluate mechanisms through which microfinance and ICB care 
impact outcomes, and analyze incremental cost-effectiveness of the 
intervention in terms of cost per HIV suppressed person-time, cost per 
patient retained in care, and cost per disability-adjusted life-year saved. 
Objectives: 
Primary Objective: 
The primary objective of this project is to 
demonstrate the effectiveness of an integrated 
community-based care approach for improving 
viral suppression and related outcomes among 
HIV-positive individuals participating in 
microfinance groups. 
Endpoints: 
Primary Endpoint: 
The primary endpoint for this study will be 
achievement of viral suppression (HIV-RNA < 400 
cp/mL) at 18 months. 
Secondary Endpoints: A secondary endpoint will be retention in care, 
defined as the proportion of scheduled visits that 
were attended during the study period. Other 
secondary endpoints will be absolute mean change 
in systolic blood pressure and absolute mean 
change in HbA1c level from 0 to 18 months. 
Study Population: 
The population eligible for study participation will include HIV-positive 
patients, at least 18 years of age, who are active members of an AMPATH 
Group Integrated Savings for Health Empowerment (GISHE) group. (An 
active group is one that was formed at least 6 months prior to study start, is 
consistently meeting as scheduled, and is actively engaging in saving and 
loaning. An active member is one who has been consistently attending 
group meetings during the 6 months prior to study enrollment and who is 
actively engaging in saving and loaning.) Eligible participants will be 
required to be currently receiving HIV-related care through AMPATH, 
have an AMPATH Medical Record System (AMRS) ID, have initiated 

 
5 
 
antiretroviral therapy at least 6 months prior to the study baseline, and be 
willing and able to provide informed consent for study participation. The 
eligible study population will also include participants who meet the same 
aforementioned criteria but are not participating in an AMPATH GISHE 
group (to serve as the matched comparison arm).  
Phase or Stage: 
Phase III Clinical Trial  
Description of 
Sites/Facilities Enrolling 
Participants: 
All research activities related to the clinical trial will be conducted within 
microfinance groups and Ministry of Health Facilities affiliated with the 
Academic Model Providing Access to Healthcare (AMPATH) in western 
Kenya. The intervention will be delivered in counties where AMPATH is 
already supporting active microfinance groups, specifically in Busia county 
and Trans Nzoia county.  
  
The Academic Model Providing Access to Healthcare (AMPATH) is based 
in western Kenya (~350km northwest of Nairobi) with primary 
headquarters in Uasin Gishu County. AMPATH is a joint partnership 
between Moi University School of Medicine, Moi Teaching and Referral 
Hospital, and a consortium of universities led by Indiana University and 
including Brown and University of Toronto. AMPATH has enrolled over 
150,000 HIV+ patients in 156 Ministry of Health facilities in western 
Kenya. All HIV and tuberculosis (TB)-related care and treatment are free 
for patients. The HIV clinical care protocols used by AMPATH are 
consistent with WHO and Kenyan National (NASCOP) guidelines and 
entail routine 12-month viral load monitoring, with more intensive 
monitoring for unsuppressed patients. Care is supported and data are 
managed via AMPATH’s electronic medical record system (AMRS). All 
care delivered in this study will be in line with clinical protocols in place 
within AMPATH. Moreover, AMPATH is already supporting more than 
1349 MF groups (with over 27,249 people) as part of their Group 
Integrated Savings for Health Empowerment (GISHE) program and the 
Bridging Income Generation with Group Integrated Care (BIGPIC) 
randomized clinical trial.   
Description of Study 
Intervention/Experimental 
Manipulation: 
A cluster randomized controlled design will be used to perform an 
evaluation of integrated community-based care incorporated into existing 
microfinance groups, where all study participants are persons living with 
HIV (PLWH). Cluster randomization will be conducted at the level of 
existing GISHE groups and will be stratified by county. 
 
We will obtain informed consent from each individual participating in the 
trial, and randomize GISHE groups in a 1:1 ratio to receive either 
microfinance plus integrated community-based care for HIV, diabetes and 
hypertension (MF+ICB) or microfinance and standard facility-based care 
(MF+SOC).  
 
The intervention (MF+ICB) will be delivered within groups during 
regularly-scheduled microfinance group meetings and include the 
following: (1) integrated care visits by a clinical offer monthly during the 
first 6 months of the trial, and then quarterly for the remaining months (7-
18), which will include one-on-one vital signs screening, consultation with 
a clinical officer, medication distribution (antiretroviral therapy for HIV 

 
6 
 
and medications for hypertension and diabetes as needed), and point-of-
care laboratory testing (creatinine, blood glucose and hemoglobin A1C, and 
viral load as it becomes available); (2) one-on-one referrals to facilities for 
emergency or acute care needs that are not able to be addressed in the 
community; and (3) group level health education discussion. Microfinance 
group members randomized to the standard of care arm (MF+SOC) will 
meet in their GISHE groups as usual and receive regular care for HIV and 
other chronic conditions at an AMPATH facility. Match control 
participants will continue to receive regular care at an AMPATH facility. 
Participant Duration: 
For each participant, the enrollment and follow-up period for the trial will 
be 18 months.   
 
 
 

 
7 
 
Acronyms  
AMPATH  
Academic Model Providing Access to Care 
AMRS 
AMPATH Medical Records System 
ART 
Antiretroviral therapy 
CARG 
CDM 
BIGPIC 
Community ART Group 
Chronic Disease Management 
Bridging Income Generation with Group Integrated Care  
FPI 
Family Preservation Initiative  
GISHE 
Group Integrated Savings for Health and Empowerment  
ICB 
Integrated Community-Based Care 
IREC 
Institutional Research & Ethics Committee  
MF 
Microfinance 
PLWH 
People Living With HIV 
VS 
Viral Suppression  
 
 
 

 
8 
 
1. Introduction  
1.1 Background  
Despite gains in antiretroviral therapy (ART) coverage for people living with HIV (PLHIV) and 
reductions in HIV-related morbidity and mortality, significant gaps remain: only 50% of PLHIV in sub-
Saharan Africa are virally suppressed.1 It is well known that retention in HIV care is a critical and 
necessary step in the continuum leading to viral suppression (VS). We have documented individual and 
system-level barriers to full engagement in care in western Kenya: distance to facilities, inefficient 
vertical care delivery, and limited means for transport and food.2–4 For PLHIV, microfinance (MF) and 
other income-generating activities can effectively improve ART adherence and viral suppression through 
strengthened food security and household economic conditions,5–7 while community-based ART delivery 
for PLHIV significantly reduces barriers related to distance and inefficient care delivery.8,9 Integrating 
HIV into primary care improves the efficiency of care delivery while addressing the growing burden of 
non-communicable disease (NCDs) among PLHIV.10 However, most Kenyans are uninsured and pay out 
of pocket for non-HIV-related healthcare, borrow from friends/family, or pay through harambee 
(Kiswahili for “pulling resources together”).11 What is still not known is how to alter care delivery to help 
support PLHIV to be continually engaged in care once they achieve relatively stable health initially 
afforded by ART. 
  
Retention in HIV care within current care delivery models in SSA continues to be sub-optimal.12-14 The 
primary barriers for retention in HIV care in western Kenya are distance to facilities, inefficient vertical 
care delivery, and limited means for transport and food. Access barriers are heightened in remote 
locations because travel is more difficult and transportation fees are prohibitively high relative to 
income.15 Overcoming these barriers is critical for PLHIV as care interruption leads to gaps in ART and 
eventual unsuppressed viral load, allowing for disease progression and increased transmission, and 
increased risk of drug resistance.16 Barriers to access and retention to care are interrelated, and require 
creative delivery models that address multilevel determinants, including economic and access issues. 
 
As health systems transition to implementing the WHO 2015 recommendations to “treat all” with ART, 
differentiated models of HIV care delivery fill an urgent need to alleviate burden on already-strained 
systems while they expand to enroll new patients on ART, and to bolster and support retention and 
adherence to ART for those already in care.17-19 The differentiated model most relevant to the current 
application – the community-based ART adherence club with quarterly group care for symptom checks 
and medication refills – has increased retention and viral suppression in South Africa while decongesting 
facilities; however, the effectiveness of this model on clinical outcomes has not been demonstrated with a 
randomized design.20  
 
The burden of NCDs in PLHIV is increasing due to improved life expectancy of PLHIV who are adhering 
to ART.21-24 Consequently, the magnitude of patients requiring chronic disease management in settings 
with strained health systems will continue to increase and overwhelm traditional care delivery models. 
HIV management may become sustainable if services are integrated into care for NCDs. While 
medication adherence clubs for HIV, diabetes and hypertension have been implemented in Kenya, the 
impact of integrated care on clinical outcomes remains uncharacterized.25,26 
 
The Academic Model Providing Access to Healthcare (AMPATH)27 provides HIV care free-of-charge to 

 
9 
 
more than 3.5 million PLHIV across 69 urban and rural clinics in Western Kenya. AMPATH also 
provides NCD care through its Chronic Disease Management (CDM) program that includes medications, 
lab tests, and clinical consultations, available to all regardless of HIV status.28,29 AMPATH’s current 
community-based NCD care and group-based microfinance program relies on earnings from the 
microfinance to fund subsidized services. Microfinance has been shown to be a sustainable and effective 
approach for improving economic outcomes for over 170 million poor people worldwide, and it provides 
unparalleled opportunities for delivering health-related services to hard-to-reach populations. 
1.2 Objectives and Rationale  
Our long-term goal is to help achieve epidemic control and the global targets of 90-90-90 through 
improved care delivery based on rigorous implementation research. The overall objective of this project is 
to demonstrate the effectiveness and longer-term sustainability of an innovative differentiated care 
delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of 
HIV care delivery into community-based primary care within group-based microfinance will improve 
retention and rates of viral suppression (VS) among people living with HIV (PLWH) in rural low-income 
settings in western Kenya via two related mechanisms: improved household economic status and easier 
access to care. The hypothesis is based on our strong feasibility and acceptability evidence of community-
based care with group microfinance for NCDs,30 the longstanding acceptability (since 2010) of our 
microfinance activities (currently >1300 groups and >43,000 people),31 and community-based HIV care 
delivery in our program.32 The rationale is that we need to implement and rigorously test specific 
differentiated care approaches in order to achieve sustained and sustainable approaches to achieve the 90-
90-90 goals. 

 
10 
 
Figure 1. Schema of the cluster randomized trial 

11 
2.
Overview of key activities during the cluster randomized trial
Pre- 
basel
ine 
Basel
ine 
Mon
th 0 
Visit 
1 
Mon
th 1 
Visit 
2 
Mon
th 2 
Visit 
3 
Mon
th 3 
Visit 
4 
Mon
th 4 
Visit 
5 
Mon
th 5 
Visit 
6 
Mon
th 6 
Visit 
7 
Mon
th 9 
Visit 
8 
Mon
th 12 
Visit 
9 
Mon
th 15 
Visit 
10 
Mon
th 18 
Enrollment: 
•
Eligibility Screening
•
Informed Consent
•
Ascertain viral load data from patient medical records
•
Alignment of patient/participant clinical appointments
with ICB care schedule
X 
X 
Randomization of GISHE groups to integrated community-
based care intervention or standard facility care 
X 
Matching of standard care (SOC) patients to enrolled 
microfinance group participants on age, gender, county 
X 
X 
X 
X 
X 
Administration of ICB care intervention 
(to MF+ICB groups only) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collection of microfinance group 
performance/participation data 
(in MF+ICB and MF+SOC only) 
X 
X 
X 
X 
X 
X 
X 
Review AMRS medical record to coordinate care needs and 
delivery  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Facility visits to collect retention in care information for Arm 
B participants of non-AMRS sites 
X 
X 
X 
X 
Survey Assessments 
(All MF groups at 0, 9, 18 months; All SOC participants at 0 
and 18 months) 
X 
X 
X 

12 
3.
Aim 1 RCT Methods: Participants, intervention, and outcomes
3.1 Study setting  
The same study protocol will be implemented at multiple independent investigational sites in Busia and 
Trans Nzoia counties in western Kenya, where participants regularly meet to attend microfinance group 
meetings in the community. Microfinance groups invited to participated in the trial can include but are not 
limited to Group Integrated Savings for Health and Empowerment (GISHE) groups run by AMPATH’s 
Family Preservation Initiative (FPI) income generation program. 
3.2 Description of the intervention and trial arms  
The study intervention (Study Arm A) will deliver integrated care for HIV, diabetes, and hypertension in 
the community to enrolled microfinance group members during regularly scheduled GISHE group 
meetings. The intervention will be delivered by a clinical team comprised of the same cadre of workers 
who deliver care in AMPATH-supported facilities (clinical officer, pharmacy technician, peer navigator, 
social worker), and include the following components:  
(1) a one-on-one clinical consultation between an AMPATH clinical officer and a microfinance
group member, during which the clinical officer will conduct vital signs screening, perform an
HIV-related clinical evaluation, perform an NCD-related clinical evaluation, distribute
antiretroviral therapy for HIV, and distribute medications for diabetes and hypertension, as
needed.
(2) one-on-one referrals of the patient by the clinical officer to a health facility for emergency or
acute care needs that cannot be addressed in the community (i.e., becomes virally
unsuppressed/viremic, presents with new opportunistic infection, is lost to follow up, has moved
out of study county, or another reason).
(3) group-level health education during which the clinical officer will discuss positive HIV
management habits and health lifestyle habits for managing chronic conditions, and GISHE group
members will be able to ask questions together.
The integrated care intervention activities will be delivered during the microfinance group meeting (either 
before or after microfinance activities based on group preference). For one-on-one activities, each 
participant will be invited to a private location near their group meeting location (e.g., private room in a 
community hall, empty classroom in an empty school) to meet with the clinical officer. For group-level 
health education activities, groups will convene in their regular GISHE meeting location (e.g., in an 
empty community hall, outdoors away from other crowds).  
Integrated care visits will occur monthly during months 1-6 of the trial, and then quarterly for the 
remaining months (7-18). Initial intervention group visits (months 1-6) will focus on acute non-HIV 
related needs and screening for NCDs, such as diabetes and hypertension. Facilities will be informed that 
participants will be receiving HIV care outside of clinic for the duration of the study, unless additional 
care is required (i.e., referral to facilities for worsening HIV, acute care, hospitalization, etc.). Care 
protocols will be put in place for handling new opportunistic infections, suspected viral resistance, 
malignancy screening and diagnosis.  

13 
Study Arm (B): Standard of Care with Microfinance. An attention-matched control design is inherent 
in this study since groups randomized to the control condition will meet as usual in their microfinance 
groups, and they will also receive regular standard of care from their usual AMPATH facility. In 
microfinance groups randomized to the standard of care condition, participants will receive the same 
services for HIV and other chronic diseases as those in the intervention arm but at their usual health 
facility. Microfinance groups in the control condition will receive clinical care services during their 
regularly scheduled clinic appointments, and pick up antiretroviral therapy and other medications for 
diabetes and/or hypertension as needed from the pharmacies following their prescribed refill schedule.  
Study Arm (C): Standard of Care Alone. N=300 adult patients who receive standard of care at 
AMPATH facilities (from the approximately 25,000 that visit monthly) will be selected to serve as a non-
randomized matched comparison to microfinance group participants. Inclusion criteria will be the same as 
criteria for individuals in Arms A and B, with the exception of not currently participating in any 
microfinance group or any community ART group. Standard-of-care-alone participants will be matched 
and enrolled following section 5.2 of this protocol.  
3.3 Eligibility criteria1 
3.3.1 
Inclusion criteria 
GISHE groups must meet the following eligibility criteria for study participation: 
•
An active AMPATH GISHE group (i.e., a group that was formed at least 6 months prior to study
enrollment, is consistently meeting as scheduled, and is actively engaging in saving and loaning)
•
An AMPATH GISHE group with a majority of group members who are AMPATH HIV patients
and have disclosed their status
Members of GISHE groups that meet the above eligibility criteria will be eligible to participate if they 
meet the following criteria: 
•
Currently 18 years of age or older
•
Living with HIV
•
Is a member of an active AMPATH GISHE group (i.e., an active group is one that was formed at
least 6 months prior, is consistently meeting as scheduled, and is actively engaging in saving and
loaning)
•
Is an active member of an active AMPATH GISHE group (i.e., an active member is one who has
been consistently attending group meetings during the 6 months prior to study enrollment and
who is actively engaging in saving and loaning)
•
Is currently receiving HIV-related care through AMPATH and has an AMPATH Medical Record
System (AMRS) ID
•
Initiated ART at least 6 months prior to study enrollment
•
Willing and able to provide informed consent for participation in the study including providing
consent to allow access to AMRS data.
3.3.2 
Exclusion criteria  
Microfinance groups will be ineligible if they are (1) a non-AMPATH microfinance group, or (2) an 
AMPATH community-ART group (CARG).  
1  See the Addendum to the overall project protocol starting on page 100 for changes made to the eligibility criteria.

14 
Members of eligible microfinance groups will be ineligible if they are (1) pregnant, (2) have an active 
HIV-related opportunistic infection or serious comorbidity such as cancer or conditions that require 
immediate hospitalization, or (3) a current participant of an AMPATH CARG. 

15 
3.4 Outcomes and endpoints 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
PRIMARY 
To evaluate the extent to which delivering integrated community-based care for HIV, 
diabetes and hypertension within microfinance groups affects viral suppression (VS) 
among people living with HIV (PLWH).  
Our working hypothesis is that A>B>C in terms of viral suppression, where (A) 
represents microfinance groups receiving integrated community-based care, (B) 
represents microfinance groups receiving facility-based care, and (C) represents 
facility-based care without microfinance. 
The primary endpoint will be 
achievement of HIV viral 
suppression (HIV-RNA <400 
copies/mL) at 18 months.2 
Viral load is considered the 
gold standard for HIV 
treatment monitoring because 
it is an objective, biological 
measure of sufficient 
adherence to antiretroviral 
therapy (ART). 
SECONDARY 
To evaluate the extent to which delivering integrated community-based care for HIV, 
diabetes and hypertension within microfinance groups affects retention in care among 
people living with HIV (PLWH).  
Our working hypothesis is that A>B>C in terms of retention in care, where (A) 
represents microfinance groups receiving integrated community-based care, (B) 
represents microfinance groups receiving facility-based care, and (C) represents 
facility-based care without microfinance. 
The secondary endpoint will 
be retention in care, defined as 
the proportion of scheduled 
visits that were attended 
during the 18-month study 
period. 
When persons with HIV are 
retained in care, they have 
better outcomes in terms 
of receiving antiretroviral 
therapy, achieving virologic 
suppression, improving 
survival, and reducing HIV 
transmission.  
To evaluate the extent to which delivering integrated community-based care for HIV, 
diabetes and hypertension within microfinance groups affects systolic blood pressure 
among people living with HIV (PLWH).  
Our working hypothesis is that A>B>C in terms of systolic blood pressure, where (A) 
represents microfinance groups receiving integrated community-based care, (B) 
represents microfinance groups receiving facility-based care, and (C) represents 
facility-based care without microfinance. 
The secondary endpoint will 
be absolute mean change in 
systolic blood pressure (mm 
Hg) over the 18-month study 
period. 
Mean change in systolic blood 
pressure has shown to be 
associated with longer-term 
cardiovascular benefit, even 
when traditional control 
thresholds are not met. 
To evaluate the extent to which delivering integrated community-based care for HIV, 
diabetes and hypertension within microfinance groups affects hemoglobin A1C 
(HbA1c) level among people living with HIV (PLWH).  
The secondary endpoint will 
be absolute mean change in 
hemoglobin A1C (HbA1c) 
level (mmol/mol) over the 18-
month study period. 
Mean change in HbA1c has 
shown to be associated with 
longer-term cardiovascular 
benefit, even when traditional 
control thresholds are not met. 
2 See the Addendum to the overall project protocol starting on page 100 for changes made to the primary endpoint.

 
16 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
Our working hypothesis is that A>B>C in terms of HbA1c level, where (A) represents 
microfinance groups receiving integrated community-based care, (B) represents 
microfinance groups receiving facility-based care, and (C) represents facility-based 
care without microfinance. 
 
 

17 
3.4.1 
Sample size 
At least forty (40) existing microfinance group clusters with n=900 people living with HIV (PLWH) will 
be randomized in a 1:1 ratio to either Study Arm A (MF+ICB) or Study Arm B (MF+SOC). Half of the 
cluters will be randomized to receive MF+ICB, resulting in approximately 450 PLWH in 20 groups in 
each of the MF+ICB and MF+SOC arms. 
The number of participants enrolled in Study Arm C (SOC) will be 300 people living with HIV 
currently receiving care at an AMAPTH facility and not participating in group microfinance. As 
participants will not be randomized to the SOC arm, we will match SOC individuals to individuals in 
MF groups (in a 1:3 ratio) such that individuals have similar characteristics with respect to key 
individual and cluster-level variables.73,74 To match individuals, we will use covariates associated with 
both microfinance enrollment and viral suppression. We will use coarsened exact matching, and check 
statistical balance of preexposure covariates for an explicitly stated specification. Section 5.2 of this 
protocol (Enrollment of patients receiving facility-based care and not engaged in microfinance) details 
the steps that will be used to match and enroll 300 standard of care facility patients.  
3.4.2 
Power calculation  
For the sample size calculations, the standard deviation of the group size was set to 5, type-one error rate 
to 0.05, a two-sided test, and the intra-class correlation coefficient to 0.05. Based on studies of the effect 
of financial interventions we expect at least 15% increase in viral suppression between MF+ICB and 
MF+SOC, between MF+SOC and SOC only, and between MF+ICB and SOC only groups.13,45 The power 
calculations used viral suppression in MF+SOC ranging from 20 to 50% and, as in the BIGPIC trial, 
accounted for 15% dropout.43 For all the different scenarios considered, the power to detect a 15% 
increase in viral suppression was greater than 80% for testing all three hypotheses.  
4.
Aim 1 RCT Methods: Enrollment
4.1 Enrollment of microfinance group members 
After identifying eligible microfinance group members, project personnel will use Adult Consent Form I 
(Appendix I) to obtain written informed consent from eligible GISHE group members (who will later be 
randomized to Study Arm A or to Study Arm B). For eligible GISHE group participants, informed 
consent will be collected in-person during a regularly scheduled GISHE group meeting.  
Among microfinance group members, the Aim 1 enrollment period will begin on November 1, 2020 and 
end when the enrollment target of n=900 GISHE group members has been met. Obtainment of written 
informed consent will be recorded in REDCap.  
General Steps for Obtaining Written Informed Consent 
-
The informed consent process should always occur in a private, confidential, and safe location.
-
Elaborate on the objectives and purposes of the study and why the potential participant may qualify.
Review the procedures that will be required of the participant. This includes naming the procedures,
the time duration of the study, and location of where it will take place. Describe all of the risks and
benefits for the procedures that are involved. Ensure that the potential participant has sufficient time
to ask questions.
-
If the subject is willing to participate under his or her own free will or the subject’s legally authorized
representative (LAR) agrees to the subject’s participation, informed consent should be documented in
the following ways:

18 
a.
The subject or the subject’s legal representative signs, personally dates and prints his or her
name in block letters on the consent form; and
b.
The person who conducts the informed consent process signs, personally dates and prints his or
her name in block letters on the consent form.
-
Provide a paper copy of the signed and dated ICF to the subject and/or the subject’s LAR.
-
Store all signed informed consent forms securely in compliance with local IRB approvals and
following the study’s Aim 1 Data Management Protocol.
4.2 Enrollment of patients receiving facility-based care and not engaged in microfinance 3 
Among AMPATH patients not participating in group microfinance, the Aim 1 enrollment period will 
begin on August 1, 2021 and end when the enrollment target of n=300 standard care patients has been 
met. Obtainment of written informed consent will be recorded in REDCap. The following steps specify 
the process that will be used for matching and enrolling 300 standard of care patients.  
Step 1. Using AMPATH’s Medical Record Systems (AMRS), the project’s data manager will filter all 
patient records in AMRS so that only those SOC patients who meet the following eligibility criteria are 
selected:  
•
Age: 18 years of age or older
•
County of residence: Busia or Trans Nzoia
•
County where patient receives care: Busia or Trans Nzoia
•
HIV Status: currently living with HIV
•
ART Status: Has been taking ART medications for > 6 months
•
Pregnancy Status: Not currently pregnant at most recent HIV care visit
•
CARG Status: Not a member of a community ART group (CARG)
Filtering all AMRS patients by eligibility criteria will create a master list (List 1) of AMRS patients 
who can be matched to enrolled microfinance group members. List 1 will need to contain at least 
1200 patients (300 SOC patients with 4 potential backups). 
Step 2. Each time a group of GISHE participants are newly enrolled in Study Arm A or B (e.g., monthly 
or quarterly), the study’s Data Assistant will send a list of the newly enrolled GISHE group members to 
the Data Manager so that the Data Manager can match these GISHE participants 3:1 to eligible SOC 
patients from List 1. The list of newly enrolled GISHE group members will contain, at minimum, the 
following information:  
•
Harambee Study ID
•
AMRS ID (if available)
•
CCC Number (if available)
•
Universal ID (if available)
•
County of Residence (Busia or Trans Nzoia)
•
Age
•
Gender
3 See the Addendum to the overall project protocol starting on page 100 for changes made to the standard of
care matching process.

 
19 
 
• 
Name of health facility where patient receives routine HIV care  
 
The Data Manager should match SOC patients from List 1 to enrolled GISHE group members on: 
(1) County of Residence, 
(2) Age (within +/- 5 years of the GISHE participant’s age),   
(3) Gender, and  
(4) Health Facility  
 
The Data Manager should also match the originally matched SOC patient to 4 backup SOC patients who  
have the same county, gender, age, and health facility as the original SOC patient. If exact matching for 
the original SOC patient is not possible, county and gender should be identical for all 4 ordered backups 
and then select each backup SOC patient whose age is closest to the original SOC patient. List 2 should 
contain, at minimum, the following information:  
• 
Harambee Study ID of matched GISHE participant  
• 
Age, sex, county, and health facility of matched GISHE participant 
• 
AMRS ID of 5 matched SOC patients (1 originally matched SOC patient and 4 ordered backups) 
• 
CCC Number of the 5 matched SOC patients (if available) 
• 
Universal ID of the 5 matched SOC patients (if available)  
• 
Age, sex, county, and health facility of all 5 matched SOC patients 
The Data Manager should return List 2 to the Data Assistant. In addition to the Harambee Study IDs, 
AMRS IDs, and other relevant IDs (e.g., CCC Number), List 2 should be formatted as in below example 
screen shot that contains faux data: 
 
In the example screenshot: id = deidentified dummy ID; case = 1(GISHE participant) / 
0(SOC Patient); sex = 1 (male) / 0 (female); county1 = 1(Busia ) / 0(Trans Nzoia); facility = 
name of health facility where patient receives HIV care. The idmatch variable indicates the 

20 
GISHE participant (e.g., idmatch = 1) and the 5 SOC of patients to whom they were matched 
(e.g., idmatch = 1_1, 1_2, 1_3, 1_4, 1_5).  
Step 3. Working closely with the AMPATH Retention Team, Harambee Data Assistant will use the 
AMRS ID from the list of matched SOC patients (List 2) to retrieve a given patient’s contact information 
from their AMPATH medical record.  
Step 4.  In both Trans Nzoia and Busia counties, the AMPATH Retention Team will then call each  
matched SOC patient on List 2 and introduce them to the Harambee RA who will - invite them to enroll 
in Study Arm C. If there is no phone number available for the first identified SOC patient in AMRS (e.g., 
idmatch = 1_1 for GISHE Participant with idmatch = 1), then the RA will visit the facility that the client 
belongs to and obtain the contact information available. If a phone number is still not identifiable, then 
the team member should proceed with contacting the next matched SOC patient for that GISHE 
participant (e.g., idmatch = 1_2 for GISHE participant with idmatch = 1).  
Step 5. To maximize efficiency, each original SOC patient and each backup SOC patient on List 2 should 
be contacted no more than twice to be invited to enroll in Aim 1. If a SOC patient is not able to be 
reached on the second attempt, the AMPATH Outreach Team of Harambee Data Assistant should 
proceed with contacting the next relevant patient on List 2. SOC patients who are unable to be reached 
after 2 attempts should not be contacted at a future date to be invited to enroll. Because a total of n=900 
GISHE participants and total of n=300 SOC patients will be enrolled during Aim 1 (GISH Participants 
matched 3:1 to SOC patients), only one-third of matched SOC patients from List 2 list should be enrolled. 
Step 6. For SOC patients who indicate that they are interested in enrolling in Aim 1, Harambee RA will 
first confirm eligibility over the phone and then schedule a time to complete informed consent procedures 
in-person using Adult Consent Form II (Appendix II). RA will complete in-person informed consent at a 
mutually convenient location agreed upon by the RA and the SOC patient (e.g., at an AMPATH-
supported health facility during the patient’s regularly scheduled HIV care visit). 
4.3 Recruitment and retention strategies  
Community mobilization and microfinance group engagement: AMPATH staff from Family Preservation 
Initiative (FPI), GESPs (community supervisors of GISHEs) and Harambee project personnel will 
conduct community mobilization meetings with microfinance group leaders to inform them about the 
study and randomization process. Additionally, research personnel will complete a mapping exercise 
during project Year 1 to assess feasibility of group engagement and willingness to participate. Only after 
obtaining acceptance from the groups for the study’s community entry will groups be approached to 
complete enrollment procedures and baseline assessments.  
Participant recruitment and retention in microfinance groups: FPI staff who have long-standing 
relationships with many of the MF group leaders will work with the investigative team in Kenya to recruit 
as many members as possible during the enrollment period. The intervention will be provided when more 
than half of the group members agree to participate. Microfinance group members who do not wish to 
participate will not be excluded from any ongoing microfinance group activities.   
Attending microfinance group meetings is on its own an incentive for retention in care since care will be 
provided in conjunction with the on-going routine meetings where participants buy shares and take turns 
borrowing money from a common savings pool. By combining care with microfinance, financial 

21 
incentives are built into the structure of this local, grassroots activity, and thus will not be expected to 
require long term (external) donor support to be sustainable.  
In the MF + ICB groups (Study Arm A), we anticipate that the community-based care intervention itself 
will be a substantial incentive for attending study visits and for ongoing study participation.  
Additionally, the following factors will also serve to increase participant retention in Study Arms A and 
B: 
•
Microfinance is a strong motivator for participation, regardless of whether participants receive
community- or facility-care
•
The social network created by the microfinance groups is a good source of information such that
peers will play an active role in recruitment and retention efforts
•
Our previous community-based care interventions show that participation and retention rates are
high because participants’ need for transportation to and from a clinical site is minimized (Arm
A)
•
The study assessments will be conducted at community locations that are convenient for
participants
•
We will hire appropriately-trained staff members to conduct recruitment and retention activities;
many staff members have already been working with the MF groups for a number of years
Participant retention in the SOC arm: Research personnel will attempt to contact identified eligible SOC 
participant up to 2 times to invite them to enroll in Aim 1. Research personnel will attempt to contact each 
enrolled SOC participant up to two times to complete the 18-month follow up assessment (i.e., viral load 
and surveys). In the event that a participant cannot be located, their most recent viral load measurement 
will be ascertained from the patient’s AMRS data to estimate viral suppression at 18 months.   
5.
Aim 1 RCT Methods: Randomization 4
Group randomization will occur after all consenting participants complete baseline assessments using a 
computer-generated sequence to randomize MF groups to receive either integrated community-based care 
(ICB) or standard of care. The randomization process will be conducted centrally by biostatisticians at 
Brown University. 
6.
Aim 1 RCT Methods: Intervention Delivery 5
Integrated care visits will occur monthly during months 1-6 of the trial, and then quarterly for the 
remaining months (7-18). Initial intervention group visits (months 1-6) will focus on acute non-HIV 
related needs and screening for NCDs, such as diabetes and hypertension. Facilities will be informed that 
participants will be receiving HIV care outside of clinic for the duration of the study, unless additional 
care is required (i.e., referral to facilities for worsening HIV, acute care, hospitalization, etc.). Protocols 
4 See the Addendum to the overall project protocol starting on page 100 for changes made to the randomization 
process. 
5 See the Addendum to the overall project protocol starting on page 100 for changes made to the schedule and 
format of intervention delivery. 

22 
for handling new opportunistic infections, suspected viral resistance, malignancy screening and diagnosis 
will follow established AMPATH care protocols.  
Prior to each intervention visit in the community, the clinical officer will review patient medical records 
to confirm each microfinance group members care needs at the upcoming visit. If an ART refill is needed 
at the upcoming visit, the clinical officer will work with the AMPATH pharmacist to prepare the ART 
medications and package them in a brown paper bag. If a NCD medication refill is needed at the 
upcoming visit, the clinical officer will work with the AMPATH pharmacist to prepare the NCD 
medication and package them in a brown paper bag.   
The study intervention (Study Arm A) will deliver integrated care for HIV, diabetes, and hypertension in 
the community to enrolled microfinance group members during regularly scheduled GISHE group 
meetings. The intervention will include the following components (Figure 2):  
(1) a one-on-one clinical consultation between an AMPATH clinical officer and a microfinance
group member, during which the clinical officer will conduct vital signs screening, perform an
HIV-related clinical evaluation, perform an NCD-related clinical evaluation, distribute pre-
packaged antiretroviral therapy for HIV, and distribute pre-packaged medications for diabetes and
hypertension, as needed.
6.1 Medication refills 
•
All antiretroviral therapy will be provided to microfinance group members free of charge in
accordance with AMPATH care protocols and national policies.
•
NCD medication costs will be charged to the patient following the discounted costs set by the
Kenya Medical Supplies Agency (KEMSA). The cost(s) of NCD medications during ICB
care visits will be the same as the NCD medication costs at the AMPATH facility. The
amount of NCD medications packaged and brought to the community visit will be enough to
last until the next integrated care visit. Each NCD patient will be allowed to buy the quantity
of NCD medication they can afford at the time of the visit (i.e., the entire refill or only a
portion of the refill). If a given patient chooses to purchase only a portion of their NCD refill,
the clinician will give the patient a prescription for the remaining quantity that the patient can
then choose to fill at a pharmacy prior to the next integrated, community care visit. After each
ICB care visit the clinician will take back all remaining drugs, as well as any and all funds
received from NCD medication refills. A written receipt will be given to each patient who
purchased a supply of NCD medication, and a copy of the receipt will be taken back to
facility and entered into the Revolving Fund Pharmacy records.
6.2 Point of care testing 
•
Viral load testing: The most recent viral load test result available in the patient’s medical
record with the 12 months prior to their enrollment date will serve as the patient’s baseline
viral load. If no test result is available, no viral load test result will be performed. For all
microfinance group members in the integrated care arm, study staff will collect a blood
sample during the 18-month study visit in the community to measure endline viral load and
assess the study’s primary outcome. AMPATH care protocols require PLWH to receive a
viral load test every 12 months such that some patients may have an additional viral load test
result in their medical record during the middle of the trial. These results will not be used in
the effectiveness analyses.

23 
Figure 2. Harambee Study Clinical Flow (Study Arm A) Updated May 09, 2021 
HIV 
HTN 
DM 
Screening 
(baseline and 
confirmatory) 
Follow-up 
(routine) 
Check VL 
Available 
Not available 
Use most recent VL w/in 
past 12mths 
Refer pt to 
facility for 
a VL test 
LDL or 
VL <400 
Viremia or 
VL > 400 
Enter study 
Refer pt 
to facility 
Screen for HTN 
Pt actively in care 
Pt defaulted/status 
unknown 
Confirm records 
Enter study if eligible 
Check BP 
SBP>140mmHg or DBP>90mmHg 
Confirm Dx in 1 mth 
Screen for DM 
Pt actively in care 
Pt defaulted/status 
unknown 
Check RBS or FBS 
RBS > 7.8 mmol/L 
HbA1C > 6.5 
Confirm Dx 
Confirm records 
Enter study if eligible 
LDL of VL <400 
Viremia or VL > 400 
-Care visits q3 mths
-ART distribution 
q3 mths 
-VL at 12mths from 
baseline VL 
Pt referred 
to facility 
until LDL 
CO to check 
on pt and 
ensure once 
LDL, pt 
referred back 
to group care
Confirmed HTN 
Care visits monthly x 6mths, then q3 mths thereafter 
Medication distribution monthly x 6mths, then q3 mths 
thereafter 
Cr test: baseline and 18 mths (Harambee-sponsored), 
Confirmed DM 
Care visits monthly x 6mths, then q3 mths thereafter 
Medication distribution monthly x 6mths, then q3 mths 
thereafter 
HbA1C/Cr test: baseline and 18 mths (Harambee-
sponsored), in between Cr tests recommended by CO 
Use most recent VL w/in 
past 12mths 

24 
Referral 
(prn) 
VL = viral load; LDL = undetectable viral load; BP = blood pressure; Tx = treatment; Dx = diagnosis; RBS = random blood sugar; Cr = creatinine; 
DKA = diabetic ketoacidosis; HHS = hyperosmolar hyperglycemic state; mth=month; prn= pro re nata ("as needed"). 
Patient with viremia or > 400 
Patient with clinical symptoms that require 
Referral recommendation as needed based on 
clinical judgement  
Documentation must be completed: VL (if 
applicable) % clinic visits successfully
Patient with emergencies requiring immediate 
management at a tertiary health facility (ie. 
hypertensive emergency, DKA/HHS) 
Referral recommendation as needed based on 
clinical judgement  
Documentation must be completed: % clinic 
visits successfully attended (successful
Patient with emergencies requiring immediate 
management at a tertiary health facility (ie. 
hypertensive emergency, DKA/HHS) 
Referral recommendation as needed based on 
clinical judgement  
Documentation must be completed: % clinic 
visits successfully attended (successful

25 
•
Creatinine test: A creatinine test will be conducted among all microfinance group members in
the integrated care arm during the baseline visit in the community and during the final 18-
month visit in the community. The baseline and endline tests will be sponsored by the study
and conducted using Creatinine cartridges and a point-of-care iStat machine that the study
team will be responsible for transporting to the group meeting location. The clinical officer
may recommend a patient seek additional creatinine tests at a facility during the trial, which
will be charged to the patient.
•
Random blood sugar (RBS): A random blood sugar test will be conducted among all
microfinance group members in the integrated care arm during the baseline visit in the
community and during the final 18-month visit in the community. The baseline and endline
tests will be sponsored by the study and conducted using a glucose strip and glucometer that
the study team will be responsible for transporting to the group meeting location. The clinical
officer may recommend a patient seek additional creatinine tests at a facility during the trial,
which will be charged to the patient.
•
HbA1C test: A hemoglobin A1C test will be conducted among all microfinance group
members in the integrated care arm during the baseline visit and during the final 18-month
visit in the community if their RBS > 7.8 mmol/L or if their FBS > 6.1 mmol/L. The baseline
and endline tests will be sponsored by the study.
•
Systolic and diastolic blood pressure will be assessed during each clinical evaluation
conducted in the community using a routine blood pressure cuff.
(2) one-on-one referrals of the patient by the clinical officer to a health facility for emergency or
acute care needs that cannot be addressed in the community (i.e., becomes virally
unsuppressed/viremic, presents with new opportunistic infection, is lost to follow up, has moved
out of study county, or another reason).
(3) group-level health education during which the clinical officer will discuss positive HIV
management habits, and health lifestyle habits for managing chronic conditions, and GISHE
group members will be able to ask questions together.
For one-on-one activities, each participant will be invited to a private location near their group meeting 
location (e.g., private room in a community hall, empty classroom in an empty school) to meet with the 
clinical officer. For group-level health education activities, groups will convene in their regular GISHE 
meeting location (e.g., in an empty community hall, outdoors away from other crowds).  
Clinical encounter data, medication distribution data and data on referrals will be recorded in REDCap in 
the community and then transferred to the patient’s medical record by the clinical officer when the 
clinical officer returns to the facility.  
7.
Aim 1 RCT Methods: Data collection, management, and analysis
7.1 Data Collection  
The trial involves the collection and use of the following types of data. With the exception of viral load 
data which will be ascertained from and/or entered directly into patient medical records, data will be 
collected using mobile tablets with secure encryption and cloud-based data capture. 
1.
We will measure HIV viral load at study enrollment and at 18-months for all enrolled trial
participants.

26 
1.1 Baseline viral load will reflect the most recent viral load measurement available in the patient’s 
medical record within the 12 months prior to their enrollment date.  
1.2 18-month viral load will be assessed using blood draws taken during the 18-month assessment in 
the community (for microfinance group members) and at the facility (for non-microfinance group 
members).  
2.
For clinical secondary outcomes, we will measure systolic blood pressure and hemoglobin A1c at
baseline and 18-months for all 900 microfinance group members enrolled in the trial. Blood
pressure will be measured in the community by the clinical officer using a blood pressure arm
cuff. HbA1c will be measured in the community by the clinical officers using a point of care test.
3.
For non-clinical secondary outcomes, we will measure retention in care on an ongoing basis for
all enrolled trial participants. Retention in care will be based on study records (REDCap) for
intervention recipients and on medical records for facility care patients.
4.
For exploratory outcomes and mediation analyses, we will collect survey data from all enrolled
trial participants: at enrollment and 18-months for all trial participants, with an additional round
of survey data collection at month 9 for all microfinance group members. Surveys will be
administered by a research assistant to participants in a private location in-person. Surveys will
assess demographics, health insurance enrollment and utilization, social support (Oslo Social
Support Scale-3), quality of life (adapted version of the MOS-HIV scale), psychological distress
(Patient Health Questionnaire-4), self-reported ART adherence (based on the adapted ACTG
Adherence Questionnaire), self-reported adherence to NCD medications (based on the extent of
DOSE-Nonadherence Questionnaire), barriers to accessing care, patient satisfaction with care,
felt HIV stigma (9-item measure of felt stigma validated in Kenya). The survey instrument is
included in Appendix III. For exploratory outcomes, we will collect data on microfinance group
performance (e.g., saving and lending activities, loan default rates) for all microfinance group
participants. Microfinance group performance data will be collected on a quarterly basis and
recorded via REDCap. The microfinance data collection tool is included in Appendix IV.
7.1.1 
Baseline assessments 
Trained research assistants will conduct baseline assessments at the first regularly scheduled MF meeting 
following study start date. During the baseline visit, participants in GISHE groups will: 
•
Complete informed consent procedures which include consenting to provide access to their
AMRS data (Appendix I)
•
Be screened for hypertension and diabetes following routine AMPATH protocols (Appendix
VIII)
•
Complete the survey assessments (Appendix III)
Participants who receive standard of care at AMPATH facilities and agree to enroll in the study (Study 
Arm C), will also complete a baseline assessment at a facility or mutually agreed upon convenient 
location. During the baseline visit, SOC participants will: 
•
Complete informed consent procedures which include consenting to provide access to their
AMRS data (Appendix II)
•
Complete the survey assessments (Appendix III)
AMRS IDs will be verified for all trial participants at enrollment. In addition, a separate contact form will 
be completed for participant follow-up and kept separately from other study documents.  

27 
7.1.2 
Follow up assessments 
For study participants in MF groups (MF + ICB and MF+SOC), follow up assessments to evaluate 
primary and secondary outcomes will be conducted in the field at 9- and 18- months. During follow up 
assessments, MF group participants will: 
•
Provide a blood draw for HIV viral load testing (study month 18 only)
•
Provide a systolic blood pressure reading (study month 18 only)
•
Provide an HbA1c point of care test, if clinically indicated (study month 18 only)
•
Complete the survey assessments (study month 9 and 18)
Trained research assistants will work with the clinical teams to collect survey assessment data on mobile 
tablets. Clinical teams will record blood pressure and HbA1c results in the patient’s medical records and 
in the study REDCap records. At 18 months, clinical officers and research assistants will transport blood 
samples from the community to the Eldoret reference lab for analysis. For participants who do not attend 
MF group meetings during assessment time points (months 9 and 18), research assistants will use 
participant’s contact information to schedule follow-up meetings to collect data if participants are willing 
to meet outside of the regularly scheduled MF meeting time. We will access and review AMRS for data 
on secondary outcomes (i.e., retention in care and chronic disease composite score).  
For study participants receiving SOC (Study Arm C), follow up assessments to evaluate primary and 
secondary outcomes will be conducted at AMPATH facilities when the patient returns for their HIV clinic 
visit at 18-months. During follow up assessments, SOC patients will: 
•
Provide a blood draw for HIV viral load testing
•
Complete the survey assessments
7.1.3 
Fidelity monitoring  
During the first six months of the study, intervention staff will meet weekly to review study progress, 
care protocols, and any issues that have arisen during the ICB care delivery activities. Following the 
initial six months, the project manager will visit 4 randomly selected intervention groups (MF+ICB) 
monthly to monitor activities and ensure that procedures for care delivery are being followed. Using a 
checklist for adherence to study protocol, the project manager will rate each session. Staff in groups 
with low ratings will be retrained and monitored for the following 3 months. During the random audit, 
any staff member found in violation of study protocol will be suspended and retrained. 
7.2 Statistical analysis 6
The primary analysis of interest is comparing viral suppression at 18 months between the MF+ICB 
(Study Arm A) and MF+SOC groups (Study Arm B). As a secondary hypothesis, we will test MF+ICB 
vs SOC alone and MF+SOC vs SOC alone. To test both the primary and the secondary hypotheses we 
will use a generalized mixed effects model.33 For the primary outcome, the model we will use is  
𝑙𝑜𝑔(𝑃(𝑌𝑖𝑗 = 1|𝐼𝑗,𝑆𝑗, 𝑉𝐵𝑖𝑗,𝑐𝑗 )) = β0 + β1𝐼𝑗 + β2𝑆𝑗 +β3𝑉𝐵𝑖𝑗 + 𝑐𝑗, 
6 See the Addendum to the overall project protocol starting on page 100 for changes made to the statistical 
analysis plan.  

 
28 
 
where, Yij is viral suppression at 18 months for participant i in cluster j, Ij is the indicator if cluster j is 
randomized to the MF+ICB arm, Sj is an indicator if cluster j comes from the SOC individuals, VBij is 
the baseline viral load for participant i in cluster j, and cj is the random effect associated with cluster j. 
The estimator β̂1estimates the difference between the MF+SOC and MF+ICB arms and positive values 
indicate higher viral suppression in the MF+ICB arm. To test the primary hypothesis we will perform a 
hypothesis test for H0: β1 = 0.  To test the secondary hypothesis we will perform a hypothesis test for 
H0: β2 = 0 and H0:β1 − β2 = 0.  
For the secondary outcomes, we will modify the above model to reflect that retention in care is a 
proportion and the absolute mean change in systolic blood pressure and HbA1c level are each a 
continuous outcome. Dropout from the study will be handled using inverse probability weighting.34 The 
design, analysis, and interpretation of the results from the trial will follow the recommendations given 
by the CONSORT statement on cluster randomized trials.35 All data will be de-identified prior to the 
analysis phase.  
8. Aim 2: Mixed methods to assess mechanisms through which MF and community-based care 
affect patient outcomes 
8.1 Study Population and recruitment  
For qualitative mediation analyses, we will conduct qualitative in-depth with 40 participants from the 
Aim 1 randomized controlled trial (n=20 from the MF+ICB arm and =20 from the MF+SOC arm). 
Following the Aim 1 trial’s 18-month assessment, research assistants will provide information to a 
purposively selected sample of n=40 participants and invite them to join the qualitative data collection. 
Following the Aim 1 trial’s 18-month assessment, research assistants will also invite n=10 current 
AMPATH staff who delivered the intervention to participate in in-depth interviews. Individuals who are 
interested in participating in the Aim 2 interviews will complete the informed consent form in Appendix 
V.  
8.1.1 
Inclusion criteria for trial participants: 
• 
consented to participate in the intervention study (Aim 1) and completed at least the baseline 
and 18-month assessment; 
• 
participated in at least 2 MF group meetings during the study period; and  
• 
able and willing to provide informed consent for the qualitative study.  
8.1.2 
Inclusion criteria for key stakeholder and care providers: 
• 
Delivered care in the intervention arm of the trial for at least 6 months;  
• 
18 years of age or older; and  
• 
Able and willing to provide informed consent to participate.  
Data for all Aim 1 participants (n=900 microfinance groups + 300 SOC) collected via the survey 
measures (Appendix III) administered at baseline, 9-month, and 18-month follow-up visits will be used 
for the for the Aim 2 quantitative mediation analyses.  
8.2 Aim 2 (mixed methods mediation analysis) procedures  
In depth interviews (IDIs) with trial participants will take place in a private and quiet location with the use 
of an interview guide. A semi-structured guide (Appendix VI) will include questions to assess the 
following domains: 1) Experiences related to MF groups, 2) Barriers/facilitators to accessing HIV care, 
including household economic conditions, food security, geography/distance, social support, and HIV-
related stigma; 3) How participation in MF and/or community-based care impacts retention in care, 

 
29 
 
adherence to ART; 4) Satisfaction with HIV care delivery (community-based or facility-based); 5) 
Suggested improvements for care delivery models.  
In depth interviews (IDIs) with intervention delivery personnel will take place in a private location, 
outside of their work location if preferred. Interviewers will be trained members of the AMPATH social 
behavioral team. Semi-strucutred interview guides (Appendix VII) with staff will focus on the following 
domains: 1) Satisfaction with job; 2) Challenges to delivering HIV care in the community; 3) Suggested 
improvements; 4) Context-specific issues delivering care in this setting related to geography, community, 
etc. Interviews will be conducted in Swahili or English by a trained member of the research staff and 
audio-recorded with permission. All interviews will be transcribed and translated in full. Transcriptions 
will be entered into a text organization software program for analysis. 
8.3 Aim 2 statistical analyses   
Quantitative mediation analyses. We will use causal mediation analysis to evaluate the importance of 
causal pathways between microfinance and integrated community-based care and viral suppression and 
retention. We will use the data described in Aim 1 collected at baseline, 9-month, and 18-month follow-
up visits. The primary analysis will focus on two main mediators: household economic conditions and 
access to care. We will estimate the mediation effect of each mediator separately using the difference 
method and account for multiple comparisons using a Bonferroni correction. The generalized linear 
models needed to implement the difference method will adjust for key confounders such as education, 
location, gender, and age. We will perform a sensitivity analysis of the assumption of no unmeasured 
mediator-outcome confounders. As a secondary analysis, we will use causal mediation analysis to 
evaluate the mediation effect of food security, social support, and HIV-related stigma. We hypothesize 
that there will be similar improvements in household economic conditions between the two MF and 
MF+ICB groups, but that barriers in access to care will be more improved in the MF+ICB arm. 
Differences in these mechanisms will provide important information regarding the additive impact of 
integrated community-based care on the hypothesized relationships. 
 
Qualitative mediation analyses. Text from the n=50 interviews will be coded into a hierarchical, 
branching structure in which broad concepts are first identified, along the domains identified in the 
interview guides and our conceptual model, and then themes and variations within those themes will be 
defined and text will be labeled according to these definitions. Coded data from intervention participants 
will be compared to identify mechanisms through which MF and community-based care impacted 
retention in HIV care and adherence to ART, and the additive impact of the community-based care 
delivery in the intervention group. Specifically, data will compare between the intervention arms the 
added benefits of community-based care, beyond those relevant to both groups from the MF activities. 
We will triangulate findings using data from the qualitative study to explain and expand on findings from 
the quantitative mediation analysis. 
9. Aim 3. Cost-effectiveness analysis  
Aim 3 will perform a cost-effectiveness analysis to test the working hypothesis that microfinance groups 
with integrated community-based care (MF+ICB) are more cost-effective compared to microfinance 
without ICB (MF+SOC) and standard care (SOC).  
9.1 Aim 3 procedures 
Costs attributable to the intervention will be collected during the randomized controlled trial (Aim 1) for 
each relevant study period at 6, 12, and 18 months. Costs will be recorded using a cost tracking tool 
developed specifically for this study. We will estimate differences in the intervention arms (MF+ICB and 
MF+SOC) and the controls (SOC). The differences in costs among the control and intervention arms will 
be defined as the incremental costs (ΔC). Cost estimates for the controls will be obtained from 

 
30 
 
AMPATH's existing electronic medical records (AMRS) as well as accounting and administrative 
records, and interviews with n=5 key informants such as administrative directors, comptroller, and local 
managers. In particular, we will use project and administrative records to conduct a cohort-based, micro-
costing approach. We will assess cost differences between the control and intervention arms including the 
total costs of the medications (ART, NCD control, etc.), as well as transportation and wait time costs. For 
each participant, we will review the AMRS to determine the actual utilization of ART, non-ART drugs, 
laboratory tests used, and clinic visits for each patient.  
9.2 Aim 3 statistical analyses 
Costs will be calculated from three distinct perspectives. First, we will take the perspective of AMPATH 
as a provider of care. Total costs will be defined as the sum of fixed and variable costs. Variable costs for 
each patient will be calculated by multiplying the number of units of each good or service used by the unit 
cost. Costs of ART will be obtained from the official AMPATH/PEPFAR supplier in Kenya. Unit costs 
for non-ARV drugs will be estimated by reviewing invoices and interviewing key informants. Clinical 
care unit costs will be estimated by multiplying the time of the clinical interaction (based on time motion 
logs) by the amount spent on staff salaries by level (medical officer, nurse, etc.) and overhead. All costs 
incurred by the project, not directly attributable to individual participants will be considered as part of the 
fixed costs. These are usually costs that are exercised regardless of the volume of participants (cleaning, 
maintenance, utilities, etc.). Fixed costs will also include any equipment bought (new testing machines, 
motorcycle, rent/space costs, etc.) which will be discounted at a rate of 5% per year to account for 
depreciation. Total fixed costs will be allocated to all the participants proportionally. Second, we will take 
into account costs from the patients point of view, which will include time and transport costs to the place 
where care is received (i.e., the clinic for the SOC vs. the microfinance meeting place for the MF+ICB 
group). Third, we will perform a potential cost-saving estimation from the point of view of government 
and donors where financial outlays are compared into the future to gauge the extent to which the proposed 
intervention can be financially self-sustained. 
Effectiveness: We will use the changes in primary and secondary outcomes, as explained in Aim 2; 
namely: viral suppression and retention-in-care. The incremental effectiveness (ΔE) will be defined as the 
difference in outcomes between the SOC and the intervention groups. 
Incremental Cost-Effectiveness Ratio (ICER) will be defined as incremental cost over incremental 
effectiveness (ΔC/ΔE). In addition, we will model incremental costs per disability-adjusted life year 
(DALY) averted to make the results comparable to the international cost-effectiveness literature. We will 
model the effects over the life span using the Sullivan method discounting future effects. For the net 
benefits estimation, we will transform costs into constant 2018 USD using the Kenyan consumer price 
index and the international average exchange rate to convert from Kenyan shillings (KES) to USD. We 
will compare the cost per DALY saved to the Kenyan income per capita (GDPpc) and deem the 
intervention extremely cost-effective if $/DALY is less than 1*GDPpc, highly cost-effective if $/DALY 
is less than 2*GDPpc, and cost-effective if $/DALY is less than 3*GDPpc.  
Sensitivity Analysis: We will use sensitivity analyses to describe the scope and nature of the inherent 
uncertainties surrounding the cost-effectiveness estimates. Each parameter in the model will be varied 
across a plausible range of in a series of one-way sensitivity analyses and those that exhibit the largest 
magnitude of influence either in effects, costs, or the resultant cost-effectiveness ratio, will be varied 
together in multi-way sensitivity analyses. In addition, we will conduct threshold analysis, whereby we 
will point out the values at which the intervention options may no longer be cost-effective; we will use a 
probabilistic uncertainty analysis for the variables that have an underlying probability distribution. 
 

31 
The final cost-effectiveness results will be measured with incremental cost effectiveness ratios comparing 
the SOC with each of the additional interventions. In addition, given that each of the innovations may 
have an optimal level of scale and diffusion, and potential cost savings from the perspective of each of 
the actors. To estimate return on investment we will use a cost-utility approach that we have successfully 
used for HIV testing and can be adopted for HIV treatment retention interventions. 
10. Protection of human subjects
This study involves research that is classified as non-exempt human subjects research. All procedures of 
this research will be conducted in accordance with 45 CFR Part 46 and will be approved by the Moi 
University School of Medicine IRB (the IRB of record) and the Brown University Institutional Review 
Board (the prime award recipient).   
10.1 Risks to human subjects 
Participation in this study involves no physical risk above the risks ordinarily encountered in daily life. 
There may be several non-physical risks associated with study participation.  
1.
There is a small risk of loss of privacy or confidentiality for participants in the trial (Aim 1) and
in the qualitative study (Aim 2). Individuals will provide information regarding sensitive topics,
such as their experiences with HIV care. All data will be de-identified to ensure no loss of privacy
or confidentiality as described in the Data Safety and Monitoring Plan. All informed consent
documents will provide participants with information regarding the potential risks of loss of
privacy.
2.
Participants may experience psychological discomfort during the qualitative interviews (Aim 2)
or during care sessions (Aim 1), however this should not be beyond what would be experienced
during the course of routine care. Interviewers, research assistants and providers will be trained
to handle emotional responses to the topics. We will take steps to minimize the psychological
discomfort of participating in this study.
3.
There is a small risk of stigma related to study participation. Individuals will be recruited into the
study based on their HIV-status. In order to ensure that participants are not stigmatized based on
participation in the study, we are intentionally operating our study within already existing
microfinance groups. Microfinance groups are only eligible for study participation if at least 70%
of their members are HIV positive. Therefore, there should be no additional stigma associated
with our study.
4.
Potential risks for this study include a minimal physical risk of bruising or discomfort from needle
sticks during venipuncture to collect blood. However, every precaution will be taken to reduce
the risk of the blood draw by hiring seasoned and proficient phlebotomists. From our prior
experience performing blood draws as part of RCTs, the discomfort associated with venipuncture
is trivial.
10.1.1 Adequacy of protection against risks 
10.1.2 Informed consent 
Informed consent will be written consent for participation in the trial and in the qualitative interviews. 
Written informed consent will be obtained by trained study staff in a private place in or near the 
regularly scheduled MF group (for trial participants) or the AMPATH clinic (for SOC participants and 

 
32 
 
clinic personnel involved in the qualitative interviews). Informed consent documents will be translated 
into Swahili or other local language and back-translated for accuracy. Informed consent will be read 
aloud to participants and they will be given the opportunity to ask questions before agreeing to 
participate. The participants will have the opportunity to read the form and take as much time as they 
need to do so. The participants will be offered a copy of the form to keep. The interviewer or research 
assistant will ask the participants if they agree to take part in the study and if they agree, both will sign 
and date the document. If participants are not literate, they will be asked to mark the page in the 
presence of a witness (another study staff member so as to not violate participant confidentiality). 
Interviewers and counselors will document that consent was provided prior to beginning any study 
procedures.  
 
Our study team has prior experience in obtaining informed consent for research and clinical trials within 
the cultural context of Kenya. The informed consent procedure has been designed to maximize 
understanding of potential risks. Participants may decline to participate at any point.  
 
10.1.3 Maintaining privacy and avoiding stigmatization  
In order to minimize potential risk of stigma, our recruitment will occur during regularly occurring 
microfinance meeting times. We expect that this technique will be very effective at minimizing any 
attention that may be paid to study participants due to the presence of our study staff in the village. We 
will only discuss the nature of the study with the study participants and will train field staff to 
appropriately respond to queries about study activities from individuals not enrolled in the study. Study 
visits to the regularly scheduled microfinance group meetings will occur in unmarked vehicles in order to 
reduce the unlikely possibility of stigmatizing study participants.  
 
Every effort will be made to ensure that privacy is maintained during the ICB care delivery visits in the 
intervention groups. All data collected during Aims 1 and 2 will be de-identified as described in the Data 
Safety and Monitoring Plan. 
 
10.1.4 Minimizing psychological discomfort  
In order to minimize risks from psychological discomfort or potential loss of confidentiality, potential 
participants will have study procedures fully explained before giving consent, with explanations about 
the potential risks involved in participation. All participants will have the opportunity to ask questions 
prior to consenting to participate. While we expect this strategy to be effective in minimizing 
psychological discomfort due to study procedures, we will offer referrals to mental health services 
offered at AMPATH for any participant in need. In cooperation with the Department of Psychiatry at 
Moi University School of Medicine and Moi Teaching and Referral Hospitals, AMPATH holds a 
special weekly clinic to meet the mental health needs of patients. Patients can be referred from any site 
for evaluation and treatment. A mental health nurse also provides onsite counseling one day per week at 
rural clinics at Mosoriot, Burnt Forest, and Turbo. The weekly clinics and onsite counseling provide 
treatment to patients with a variety of disorders, including depression, psychosis, and substance abuse.   
 
10.1.5 Minimizing risk to due to venipuncture 
In order to minimize risk due to venipuncture we will only hire and train staff with experience collecting 
blood samples. Our phlebotomists will make every effort to minimize physical discomfort due to the 
blood draw procedures.  

 
33 
 
10.2 Data safety and monitoring plan  
The first aim of this study involves a cluster randomized trial as well as secondary analysis of data from 
electronic medical records and recorded as part of usual care. This data will be managed and secured 
following standard operating procedures within AMPATH. Only the AMPATH data manager will have 
access to the identifiable data. A unique study identifier will be used to identify participants. Only the 
principal investigators (MPI Drs. Galarraga and Genberg and PI Wachira) and the data manager will 
have access to the file linking the unique study identifier to identifiable data. All data will be de-
identified prior to analysis. All data files will be kept securely with password protection. Similar 
procedures will be put in place to safeguard data collected from surveys for Aim 2.  
  
The second aim will also involve in-depth interviews that will include digital recordings, transcripts and 
notes by the interviewer. The interviewer and the MPIs will have access to this data. Transcripts sent 
out for translation will have no identifiable information included. We will use a service that has a 
history of experience working with AMPATH and other medical data. Qualitative data will also be 
stored on secure servers, protected by password and encryption. The data will not include identifying 
information. Any information used to recruit and schedule appointments, such as first name, mobile 
numbers, or addresses will be destroyed following data collection.  
  
The third study aim will involve in-depth costing interviews and working meetings organized in six 
major steps: (1) accessing and organizing the annual financial reports into logical sub-categories; (2) 
reorganizing the subcategories into input cost categories to create a financial cost profile; (3) estimating 
the annual equivalent payment for program equipment; (4) documenting donations to the  program 
implementation; (5) including any portion of the organizational costs not attributed to specific 
programs; and (6) including the results of Steps 3-5 into an expanded cost profile. Note that the costing 
interviews will not be audio recorded, and instead only aggregate costing numbers will be agreed upon 
and completed in already pilot-tested Excel spreadsheets which we have successfully used in similar 
projects.  
 
All research personnel will adhere to the comprehensive Data Safety and Monitoring Plan that was 
submitted to and approved by the NIH Program Officer for this project.  
 
10.3 Potential benefits of the proposed research to the participants and others 
There is no direct benefit of the proposed research to study participants. However, if the intervention is 
successful, individuals in the intervention study may benefit from HIV and NCD care delivered in a more 
convenient setting. More regular engagement in HIV care is associated with many improved patient 
outcomes and individuals in the study will have the opportunity to receive more convenient HIV care with 
a trained clinical staff member. It is possible that individuals in western Kenya as a whole will benefit 
from this study as it is designed to test a differentiated model of care delivery. If we can successfully 
intervene and engage patients with HIV into more regular HIV care and increase viral suppression among 
people living with HIV, there will be important benefits for individual patient outcomes, as well as at the 
population level in terms of reduction in HIV incidence. Given these potential benefits, we believe the 
risks for participation are reasonable.  

 
34 
 
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38 
Appendix I: Adult Consent Form 1 
(For microfinance group members who are asked to enroll in Aim 1) 
Title of Research: 
Harambee: Integrated Community-Based HIV/NCD Care and 
Microfinance Groups in Kenya 
Principal Investigators: 
Juddy Wachira; Becky Genberg; Omar Galarraga 
IREC Approval #:  
0003054 
Sponsor: 
National Institute of Mental Health (NIMH) 
Version Date: 
23 February 2021  
What you should know about this study 
Unachopaswa kujua kuhusu utafiti huu 
•
You are being asked to join a research study.
Unaulizwa kujiunga na utafiti huu.
•
This consent form explains the research study and your part in the study.
Fomu hii ya idhini inalezea kuhusu utafiti na jukumu lako kwenye utafiti.
•
Please read it carefully and take as much time as you need.
Tafadhali isome kwa umakini na uchukuwe muda mwingi kadri unavyohitaji.
•
You are a volunteer. You may choose not to take part in the study at all. If you choose to join
the study, you may quit at any time. There will be no penalty if you decide to quit the study.
Wewe ni mtu ambaye amejitolea. Unaweza kuchagua kutoshiriki kabisa katika utafiti.
Ikiwa unachagua kujiunga na utafiti, una hiari wa kutoka kwenye utafiti huu wakati
wowote. Hakutakuwa na adhabu yoyote ukiamua kutoka kwenye utafiti.
•
During the study, we will tell you right away if we learn any new information that might
affect whether you wish to continue to be in the study.
Kwa wakati wa utafiti, tutakueleza mara moja endapo tutapata kujua kuhusu habari
yoyote mpya ambayo inaweza kuathiri ikiwa unataka kuendelea kuwa kwenye utafiti.
What is the purpose of research study? 
Je, ni nini kusudi la utafiti huu? 
The purpose of this research study is to learn if offering HIV care and other health services in the 
community, instead of at a health facility, will help people who are living with HIV to live healthier lives. 
This research study also wants to learn if offering HIV care and other health services to people who are 
members of microfinance groups will help people who are living with HIV to live healthier lives.  
Kusudi la utafiti huu ni kuweza kujua ikiwa kupeana huduma ya HIV na huduma zingine za afya 
katika jamii, badala ya kwenye kituo cha afya, itawasaidia watu wanaoishi na HIV kuishi maisha 
yenye afya. Utafiti huu pia unataka kujua ikiwa kutoa huduma ya HIV na huduma zingine za afya 
kwa watu ambao ni wanachama katika vikundi vya mikopo midogo itawasaidia watu wanaoishi na 
HIV kuishi maisha yenye afya.  

39 
Why we are asking you to participate? 
Je, ni kwa nini tunakuuliza ushiriki? 
You are being asked to participate in this study because: 
Unaulizwa kushiriki katika utafiti huu kwa sababu: 
1) You are at least 18 years old
Una angalau umri wa miaka 18
2) You are an HIV patient
Wewe ni mgonjwa anayeishi na HIV
3) You have been taking antiretroviral (ART) medications for the past 6 months or longer
Umekuwa ukitumia dawa za ART kwa miezi 6 iliyopita au zaidi
4) You receive care for HIV at an AMPATH HIV clinic
Unapokea huduma ya HIV katika kliniki ya AMPATH
5) You have an AMPATH identification number
Una nambari ya kitambulisho cha AMPATH
6) You have been a member of an active microfinance group for the past 6 months or longer
Umekuwa mwanachama wa kikundi cha mikopo midogo na kinachoendelea na kazi zake
kwa miezi 6 iliyopita au zaidi
7) You do not have serious infections or illnesses that require immediate care or hospitalization
Hauna maambukizo makali au magonjwa yanayohitaji huduma ya haraka au kulazwa
hospitalini
8) You are not a member of a community ART group (CARG)
Wewe sio mshiriki wa kikundi cha kupokea madawa ya ARVs katika jamii
9) You are not pregnant
Wewe si mjamzito
What will happen if you agree to participate in the study? 
Je, ni nini itatokea ikiwa utakubali kushiriki katika utafiti? 
If you agree to participate in the study, your microfinance group will be assigned to Group A or Group B. 
The chances that you will be in Group A or Group B are equal because they are picked by chance (like 
tossing a coin – the chances of getting each side are the same).  
Ikiwa unakubali kushiriki kwenye utafiti, kikundi chako cha mikopo midogo kitapewa aidha katika 
kundi A au kundi B. uwezekano wa kuwa katika kundi A au B ni sawa kwa sababu unachaguliwa 
kwa bahati (kama vile katika kutupa sarafu- uwezekano wa kupata kila upande ni sawa). 
If you are assigned to Group A, you will attend your regular microfinance group as normal. When you 
attend your microfinance group, you will also meet with AMPATH staff members and members of this 
research study. The AMPATH staff will take your vital signs (blood pressure, temperature, heart rate, 
height, weight, waist circumference, etc.) and give you medicine for your HIV for free. If you have high 
blood pressure or diabetes, you will receive medicine for a fee. The price you will pay for the blood 
pressure or diabetes medicines will be similar to prices at the AMPATH pharmacy. During your time in 
this study, AMPATH staff will also take samples of your blood to test your HIV levels (viral load) to see 
how healthy you are. The frequency of this blood test depends on your age and the amount of HIV virus 
in your body. At a minimum, we will take a blood sample at least once at the end of the study during your 

 
40 
 
microfinance group meeting. We will also test your blood sugar levels to know if you have diabetes. At a 
minimum, this will occur two times, one at the beginning (baseline) and another at the end of the study 
(18 months) at no cost to you. If you are found to have diabetes, you will pay a subsidized fee for any 
additional tests you may need. You will also speak with an AMPATH counselor. If you have any 
problems or concerns, the counselor will help you and refer you to the AMPATH clinic if you have an 
emergency.  
Ikiwa umepewa Kundi A, utahudhuria kikundi chako cha kila mara cha mikopo midogo kama 
kawaida. Unapohudhuria kikundi chako cha mikopo midogo, utakutana pia na wafanyikazi wa 
AMPATH na wasaidizi katika utafiti huu. Wafanyikazi wa AMPATH watapima ishara zako za 
mwili (presha, kiwango cha joto mwilini, mapigo ya moyo, urefu, uzito, mduara wa kiuno, n.k.) na 
kukupatia dawa zako za HIV bure bila malipo. Ikiwa una ugonjwa wa presha au kisukari, 
utapokea madawa kwa malipo. Bei utakayolipia madawa ya ugonjwa wa presha au kisukari 
itakuwa sawia na bei kwenye duka la dawa la AMPATH. Wakati wa huu utafiti, mfanyikazi wa 
AMPATH pia atachukua sampuli za damu yako ili kupima viwango vya virusi vya HIV (viral load) 
kuona jinsi ulivyo heri wa afya.  Mara ya kurudia vipimo hivi vya damu inategemea na umri wako 
na kiwango cha virusi vya HIV katika mwili wako. Kwa kiwango cha chini, tutachukua sampuli ya 
damu angalau maramara moja mwisho wa utafiti (miezi 18) katika kikundi chako bila malipo 
yeyote. Pia tutapima kiwango chako cha sukari ili kujua ikiwa una ugonjwa wa kisukari. Kwa 
kiwango cha chini, hii itatendeka mara mbili, moja hapo mwanzoni (baseline) na nyingine hapo 
mwishoni mwa utafiti (miezi 18) bila gharama yoyote kwako. Ikiwa utagundulika kuwa na ugonjwa 
wa kisukari, utalipa bei ya chini kidogo kwa vipimo vyovyote vya ziada unavyohitaji. Pia 
utazungumza na mshauri wa AMPATH. Ikiwa una shida yoyote au wasiwasi wowote, mshauri 
atakusaidia na akupatie rufaa uende kwa kliniki ya AMPATH endapo kuna udharura. 
 
If you are assigned to Group B, you will participate in your regular microfinance group as normal and 
will continue to get HIV care and services for blood pressure and diabetes as normal; either at the 
AMPATH clinic or any health facilities when you go for your regular appointments.  
Ikiwa umepewa Kundi B, utahudhuria kikundi chako cha kila mara cha mikopo midogo kama 
kawaida na utaendelea kupokea huduma ya HIV na huduma za ugonjwa wa presha na wa kisukari 
kama kawaida; aidha katika kliniki ya AMPATH au kituo chochote cha afya wakati 
unapotembelea kliniki yako jinsi ilivyopangwa.  
If you are assigned to Group A or Group B, you will be asked to complete one survey 3 times during the 
study: once in the beginning, once in the middle (at 9 months), and once at the end of the study (at 18 
months). This survey will ask questions about your household, access to food, access to HIV care, your 
medications, your community and your general health and well-being. In addition, we will also collect 
information every three months related to your microfinance activities including your saving and loaning 
activities. 
Ikiwa umepewa Kundi A au Kundi B, utaulizwa kukamilisha maswali sawia mara 3 kwa wakati wa 
utafiti: mara moja mwanzoni, mara moja katikati (katika miezi 9), na mara moja mwisho wa 
utafiti (kwa miezi 18). Utafiti huu utauliza maswali kuhusu familia yako, kupatikana kwa chakula, 
kupatikana kwa huduma ya HIV, jamii yako na afya na ustawi wako kwa jumla. Kwa kuongezea, 
tutakusanya habari kila baada ya miezi mitatu inayohusiana na shughuli zako za kikundi cha 
mikopo midogo pamoja na shughuli zako za kuweka akiba na kukopa. 

 
41 
 
 
In addition, the research team will also collect information about you from your AMPATH and other 
medical records throughout the study. This information will include demographics (e.g. age, gender), 
diagnoses for HIV, your HIV health, HIV-related infections and other illness like blood pressure and/or 
diabetes, medication history, the number of times you attend your clinic appointments, the number of 
times you participate in a study visit, and the dates of these visits and appointments.  
Kwa kuongezea, timu ya utafiti itakusanya pia habari kukuhusu kutoka kwa rekodi zako za 
AMPATH na rekodi zingine za matibabu wakati wote wa utafiti. Habari hii itajumuisha habari 
zako binafsi (k.m. umri, jinsia), hali ya HIV, afya yako na HIV, maambukizo yanayohusiana na 
HIV na magonjwa mengine kama Presha na / au ugonjwa wa kisukari, historia ya matibabu, mara 
ngapi unahudhuria kliniki yako jinsi ilivyopangwa, mara ngapi unashiriki kwenye utafiti huu 
mnapotembelewa, na tarehe ya mitembeleo yenyewe na ratiba jinsi ilivyopangwa. 
 
We do not know whether receiving care in Group A or in Group B is better, or if they are the same. The 
purpose of the study is to answer this question. No matter which group you are in, you should continue to 
take your medicines according to your doctor’s instructions. 
Hatujui ikiwa kupata huduma katika Kundi A au katika Kundi B ni bora, au ikiwa ni sawa. 
Madhumuni ya utafiti huu ni kujibu swali hili. Haijalishi uko katika kikundi gani, unapaswa 
kuendelea kumeza dawa zako kulingana na maagizo ya daktari wako. 
 
Explanation of Procedures  
Maelezo ya Taratibu 
 
The following steps will be followed if you agree to participate in the study: 
Hatua zifuatazo zitafuatwa ikiwa unakubali kushiriki kwenye utafiti: 
 
Step 1: Baseline Assessment  
To be eligible for this study, you must meet our inclusion and exclusion criteria. A member of the 
research team will speak with you to make sure you can participate in this study.  
Ili kuhitimu kushiriki katika utafiti huu, lazima ufikie vipengele vyetu vya kujumuishwa na 
kutengwa. Mshiriki wa timu ya utafiti atazungumza nawe ili kuhakikisha kwamba unaweza 
kushiriki katika utafiti huu. 
 
If you agree to participate in the study today, we will confirm your HIV viral load from your AMPATH 
medical records. We will tell you the results of your blood test as soon as they are available. We will also 
perform a finger prick to test your blood sugar for diabetes. We may do another finger prick to confirm 
whether you have diabetes or not. We will tell you the result of the finger prick as soon as they are 
available. We will also measure your height, weight, temperature, waist circumference, and heart rate. To 
know if you have high blood pressure, we will measure your upper arm blood pressure as you sit quietly 
on a chair. If your blood pressure is high, we will measure your upper arm blood pressure again in 2 
weeks and tell you the results as soon as they are available.   

 
42 
 
Ikiwa unakubali kushiriki kwenye utafiti leo, tutahakikisha kiwango cha virusi kwa damu yako 
kupitia redoki zako za AMPATH. Tutakuambia matokeo ya kipimo hicho cha (viral load) damu 
mara tu yatakapopatikana. Pia tutachomoza kidole chako ili kupima kiwango cha  sukari kwa ajili 
ya ugonjwa wa kisukari. Tunaweza kuchomoza kidole chako kwa mara nyingine ili kudhibitisha 
ikiwa una ugonjwa wa kisukari au la. Tutakuambia matokeo ya kipimo hicho sukari mara tu 
yatakapopatikana. Pia tutapima urefu wako, uzito, kiwango cha joto mwilini, mduara wa kiuno, na 
kiwango cha mapigo ya moyo. Ili kujua ikiwa una ugonjwa wa Presha, tutapima Presha kwa 
mkono wako kwenye sehemu ya juu unapokaa kwa utulivu kwenye kiti. Ikiwa Presha yako iko juu, 
tutapima Presha kwa mkono wako kwenye sehemu ya juu tena katika wiki 2 na kukuambia 
matokeo mara tu yatakapopatikana. 
 
Lastly, you will also complete a survey today that will ask you questions about your household, access to 
food, access to HIV care, your medications, your community and your general health and well-being. 
Mwishowe, utakamilisha maswali leo ambayo yataulizia kuhusu familia yako, kupatikana kwa 
chakula, kupatikana kwa huduma ya HIV, jamii yako na afya na ustawi wako kwa jumla.   
 
 
Step 2: Study Visits  
Mitembeleo katika Utafiti 
Group A: During the study, a clinical officer (CO) and research staff will come to your regular 
microfinance group meetings every month for the first 6 months of the study and then every 3 months for 
the last 12 months of the study. On days when the CO and research staff come to your group, they will: 
Kundi A: Kwa wakati wa utafiti, daktari na wafanyikazi wa utafiti huu watakuja kwenye mikutano 
yenu ya kawaida ya kikundi cha mikopo midogo kila mwezi kwa miezi 6 ya kwanza ya utafiti na 
kisha kila miezi 3 kwa miezi 12 za mwisho wa utafiti. Katika siku ambazo daktari na wafanyikazi 
wa utafiti watakuja kwenye kikundi chako, wata: 
 
• 
Attend to your health needs 
Shughulikia mahitaji yako ya kiafya 
• 
Take your vital signs as described above 
Kupima ishara zako za mwili kama ilivyoelezwa hapo juu 
• 
For HIV: count your pills and give you free medicines for your HIV  
Kwa HIV: hesabu tembe zako na kukupatia dawa za bure kwa ajili ya HIV 
• 
For high blood pressure, measure your blood pressure at no cost to you and give you medicines at 
a subsidized fee 
Kwa ugonjwa wa Presha, pima Presha yako bila gharama yoyote kwako na kukupatia 
dawa kwa bei iliyopunguzwa 
• 
For diabetes, measure your blood sugars and give you medications at a subsidized fee 
Kwa ugonjwa wa kisukari, pima kiwango chako cha sukari kwenye damu na kukupatia 
dawa kwa bei iliyopunguzwa 
• 
Provide peer support if you are feeling unhappy or have any other issues that you want to discuss 
at no cost to you 

 
43 
 
Peana  ushauri ikiwa unajisikia hauna furaha au una mambo mengine ambayo unataka 
kujadili bila gharama yoyote kwako 
 
If there are any issues with your health that the CO cannot address, s/he will refer you to the nearest 
health facility so that you can receive the care that you need.  
Ikiwa kuna shida yoyote na afya yako ambayo daktari hawezi kushughulikia, atakupea rufaa 
uende kwenye kituo cha afya kilicho karibu ili uweze kupata huduma unayohitaji. 
 
Group B: You will continue to receive care at your usual AMPATH clinic. For hypertension and diabetes 
management, you will receive that care by a clinician at the nearest AMPATH clinic or any health 
facilities that is most convenient to you. Our team can provide you with a list of available clinic locations. 
Kundi B: Utaendelea kupokea huduma katika kliniki yako ya kawaida ya AMPATH. Kwa 
matibabu ya ugonjwa wa Presha na Kisukari, utapokea huduma hiyo kupitia kwa daktari katika 
kliniki ya AMPATH iliyo karibu au vituo vyovyote vya afya ambavyo ni rahisi kwako kuvifikia. 
Timu yetu inaweza kukupatia orodha ya maeneo mbalimbali ya kliniki. 
 
Your microfinance group will continue to meet at the normal time, days and location. Members of the 
same microfinance group will always be in the same group for this study. 
Kikundi chako cha mikopo midogo kitaendelea kukutana kwa wakati wenu wa kawaida, kwa siku 
na eneo la kawaida. Wanachama wa kikundi sawia cha mikopo midogo watakuwa kwa kundi sawa 
katika utafiti huu. 
 
 
What happens if I decide to stop my treatment? 
Je, ni nini kitafanyika ikiwa nitaamua kuachana na matibabu yangu? 
 
If you choose to stop receiving care in Group A or B before the end of the study, or if you decide you 
cannot complete all of the care visits:  
Ikiwa unachagua kuacha kupokea huduma katika Kundi A au B kabla ya mwisho wa utafiti, au 
ikiwa unaamua hauwezi kukamilisha mitembeleo yote kwa ajili ya huduma: 
 
• 
You will be asked to return to your usual clinic care at AMPATH and continue receiving care as 
you previously did before joining the study 
Utaulizwa urudi kwenye kliniki yako ya kawaida huko AMPATH na uendelee kupokea 
huduma kama hapo awali kabla ya kujiunga na utafiti 
• 
We will contact you at the end of the study (18 months) to test your HIV viral load and blood 
sugar levels, measure your blood pressure, and to complete the surveys. Participation in these 
surveys is voluntary. 
Tutawasiliana nawe mwishoni mwa utafiti (miezi 18) ili kupima kiwango cha virusi vya 
HIV (viral load) na kiwango cha sukari kwenye damu, kupima Presha yako, na 
kukamilisha mahojiano. Kushiriki katika mahojiano haya ni kwa hiari. 
 

 
44 
 
If you choose to leave your microfinance group before the end of the study, or if you decide you cannot 
complete all of the microfinance visits: 
Ikiwa unachagua kuondoka kwenye kikundi chako cha mikopo midogo kabla ya mwisho wa utafiti, 
au ikiwa unaamua hauwezi kukamilisha mitembeleo yote ya kikundi cha mikopo midogo: 
 
• 
For Group A, you must decide whether you will want to (1) continue receiving care at the 
community during microfinance group meetings or (2) be referred back to receiving care at your 
AMPATH clinic as you previously did before joining the study. 
Kwa Kundi A, lazima uamue ikiwa utataka (1) kuendelea kupokea huduma katika jamii 
wakati wa mikutano ya kikundi cha mikopo midogo au (2) kupewa rufaa urudi  kupokea 
huduma katika kliniki yako ya AMPATH kama hapo awali kabla ya kujiunga na utafiti. 
 
• 
For Group B, you will continue receiving care at your usual AMPATH clinic.  
Kwa Kundi B, utaendelea kupokea huduma katika kliniki yako ya kawaida ya AMPATH. 
 
• 
For both groups, we will contact you at the end of the study (18 months) to test your HIV viral 
load and blood sugar levels, measure your blood pressure, and to complete the surveys. 
Participation in these surveys is voluntary.  
Kwa makundi yote mawili, tutawasiliana nanyi mwishoni mwa utafiti (miezi 18) ili kupima 
kiwango cha virusi vya HIV (viral load) na kiwango cha sukari kwenye damu, kupima 
Presha yako, na kukamilisha mahojiano. Kushiriki katika mahojiano haya ni kwa hiari. 
What happens if I become pregnant during the study? 
Je, ni nini itafanyika ikiwa nitakuwa mjamzito wakati wa utafiti? 
 
Women who are part of study Group A and become pregnant while in the study will be asked to go back 
to the HIV clinic and attend their scheduled clinic visits. A pregnant woman in Group A will be 
encouraged to continue coming to her microfinance group, but the CO will not be able to deliver her 
drugs or attend to her clinical care needs in the community. She must go to the clinic to get her HIV 
drugs. Women who are part of study Group B who become pregnant during the study will be seen in the 
HIV clinic. We do not think there will be more risk to the pregnant woman or the unborn baby by 
participation in the study. However, this study will not directly help pregnant women or their babies. 
Wanawake ambao ni mojawapo wa washiriki kwenye kundi A la utafiti na wanakuwa wajawazito 
wakati wa utafiti wataulizwa kurudi kwenye kliniki ya HIV na kuhudhuria kliniki zao jinsi 
ilivyopangwa. Mwanamke mjamzito katika Kundi A atahimizwa kuendelea kuja kwenye kikundi 
chake cha mikopo midogo, lakini daktari hataweza kumpelekea dawa zake au kuhudumia mahitaji 
yake ya kikliniki huko katika jamii. Lazima aende kliniki ili aweze kupokea dawa zake za HIV. 
Wanawake ambao ni mojawapo wa washiriki kwenye Kundi B ambao wanakuwa wajawazito 
wakati wa utafiti wataonekana katika kliniki ya HIV. Hatufikiri kwamba kutakuwa na hatari zaidi 
kwa mama mjamzito au mtoto ambaye hajazaliwa kushiriki katika utafiti. Hata hivyo, utafiti huu 
hautasaidia moja kwa moja wanawake wajawazito au watoto wao. 
 
Risks of taking part in this study 

 
45 
 
Hatari ya kushiriki katika utafiti huu 
 
Blood draws 
Kutolewa kwa damu 
Taking blood may cause some discomfort, bleeding, or bruising where the needle enters the body, light 
headedness, and in extremely rare cases, fainting or infection. However, the study staff are well trained to 
perform blood draws and we do not expect any complications to you from the procedure. 
Kutolewa kwa damu kunaweza kusababisha usumbufu, kuvuja damu, au alama kwenye sehemu 
ambapo sindano inadungiwa kwa mwili, uwepesi kichwani, na katika hali nadra sana, kuzirai au 
kupata maambukizo. Hata hivyo, wafanyikazi wa utafiti wamefuzu katika hiyo kazi ya kutoa damu 
na hatutarajii shida yoyote kwako kutokana na kitendo hiki. 
 
Risk of losing confidentiality and increased stigma 
Hatari ya kupoteza usiri na kuongezeka kwa unyanyapaa 
 
For people in Group A, there is a risk of losing confidentiality (privacy) and increased stigma because of 
the community visits by the CO. This may cause other family members or neighbors to become curious. 
However, the study team will be as unnoticeable as possible while making community visits. Nobody 
outside of your group will be told the reason for the visits and only fellow study participants are allowed 
to be present during this part of the study. For people in Group B, there is also a risk of losing privacy. 
However, the clinic staff will be sure that your records are kept safe and your personal information is not 
given to anybody without permission. All of the information you provide and all of your responses to the 
survey will be coded with a study ID and will never include your name. 
Kwa watu katika Kundi A, kuna uwezekano wa kupoteza usiri (faragha) na kuongezeka kwa 
unyanyapaa kwa sababu ya mitembeleo hii ya daktari katika jamii. Hii inaweza kusababisha 
wanafamilia wengine au majirani kudadisi zaidi. Hata hivyo, timu ya utafiti haitatambulika 
iwezekanavyo wakati wa kufanya mitembeleo hii katika jamii. Hakuna mtu yeyote nje ya kikundi 
chako atakayeambiwa sababu za mitembeleo hii na ni washiriki wenzako tu katika utafiti huu 
watakaoruhusiwa kuwepo wakati wa sehemu hii ya utafiti. Kwa watu katika Kundi B, pia kuna 
hatari ya kupoteza usiri. Hata hivyo, wafanyikazi wa kliniki watahakikisha kwamba rekodi zako 
zimehifadhiwa salama na habari zako zozote za kibinafsi hazitapewa mtu yeyote bila ruhusa. 
Habari zote unazotoa na majibu yako yote kwenye utafiti yatawekwa kutumia nambari fiche ya 
kitambulisho cha utafiti na haitajumuisha jina lako kamwe. 
 
Benefits of taking part in the study 
Faida za kushiriki katika utafiti 
There is no direct benefit for participating in this study; however, the information learned from this study 
may help other people who are living with HIV for two reasons. One, it will help determine if offering 
HIV care and other health services in the community, instead of at a health facility, will help people who 
are living with HIV to live healthier lives. Two, it will help determine if offering HIV care and other 

 
46 
 
health services to people who are members of microfinance groups will help people who are living with 
HIV to live healthier lives. 
Hakuna faida ya moja kwa moja kwa kushiriki katika utafiti huu; hata hivyo, habari zinazotokana 
na utafiti huu zinaweza kusaidia watu wengine ambao wanaishi na HIV kwa sababu mbili. 
Kwanza, itasaidia kuamua ikiwa kutoa huduma ya HIV na huduma zingine za afya katika jamii, 
badala ya kwenye kituo cha afya, itasaidia watu ambao wanaishi na HIV kuishi maisha yenye afya. 
Ya pili, itasaidia kuamua ikiwa kutoa huduma ya HIV na huduma zingine za afya kwa watu ambao 
ni washiriki wa vikundi vya mikopo midogo itasaidia watu ambao wanaishi na HIV kuishi maisha 
yenye afya. 
 
Confidentiality 
Usiri  
We will try very hard to keep your records confidential (private). We cannot guarantee absolute privacy. 
Your medical information could be shared if required by the law. Only a coded number, not your name, 
will be used to identify your information on study materials. Your name will not be used in any reports 
that the study may publish. A group of people may look at our records to make sure they are complete and 
true. A group may also look at our records for data analysis (to see what the information people shared 
with us means). The groups looking at the records could be study investigators and their research partners, 
the Moi Institutional Research and Ethics Committee (IREC), the Indiana University Institutional Review 
Board (IRB), the Brown University IRB, the Purdue University IRB, the Johns Hopkins University IRB, 
the study staff, or the sponsor (NIH). 
Tutajitahidi sana kuhifadhi rekodi zako kwa siri (faragha). Hatuwezi kuhakikisha usiri kabisa. 
Habari zako za matibabu zinaweza kupeanwa ikiwa inahitajika kulingana na sheria. Ni nambari tu 
fiche, sio jina lako, itatumika kutambua habari zako kwenye nakala za utafiti. Jina lako 
halitatumika katika ripoti zozote ambazo utafiti unaweza kuchapisha. Kikundi cha watu kinaweza 
kuangalia rekodi zetu ili kuhakikisha kuwa zimekamilika na ni za kweli. Kikundi kinaweza pia 
kuangalia rekodi zetu kwa uchambuzi wa habari (kuona ni nini maana ya habari ambazo watu 
walishiriki nasi). Vikundi vitakavyoangalia rekodi vinaweza kuwa wachunguzi wa utafiti na 
washiriki wao wa utafiti, Kamati ya Utafiti na Maadili ya Taasisi ya Moi (IREC), Bodi ya Ukaguzi 
ya Taasisi ya Chuo Kikuu cha Indiana (IRB), IRB ya Chuo Kikuu cha Brown, IRB ya Chuo Kikuu 
cha Purdue, IRB ya Chuo Kikuu cha Johns Hopkins, wafanyikazi wa utafiti, au mdhamini (NIH). 
 
Data Sharing 
Kushiriki Takwimu 
 
We will not share the data from this study with anyone outside of our study staff team. 
Hatutashiriki habari zozote kutoka kwa utafiti huu na mtu yeyote nje ya timu ya wafanyikazi 
katika utafiti. 
 
Protecting your privacy during data collection 

 
47 
 
Kulinda usiri wako wakati wa utafiti 
 
Participation in this study involves multiple visits from AMPATH staff who will include a clinical 
officer, pharmacy technician, peer navigator, and social worker. Staff will conduct visits during your 
regular scheduled microfinance group and will meet with you in a location that is private and away from 
the other group members. Because we want to ensure your privacy during these visits, we will ask anyone 
nearby, either family members or neighbors, to relocate until after we are finished.   
Kushiriki katika utafiti huu kunahusisha mitembeleo mingi kutoka kwa wafanyikazi wa AMPATH 
ambao watajumuisha daktari wa kliniki daktari katika famasia, mhudumu ambaye pia ana virusi 
vya HIV, na mhudumu wa masuala ya kijamii. Wafanyikazi watatembelea wakati wa mikutano ya 
kikundi chako cha kawaida cha mikopo midogo na watakutana nawe katika eneo ambalo ni la 
faragha na mbali na wanachama wengine kwenye kikundi. Kwa sababu tunataka kuhakikisha usiri 
wako wakati wa mitembeleo hii, tutamwuliza mtu yeyote aliye karibu, awe wanafamilia au 
majirani, kukaa mbali hadi tutakapomaliza. 
 
Costs 
Gharama 
 
For HIV, your medications and care services (physical examinations, viral load tests, peer support) will 
continue to be provided at no cost to you. 
Kwa HIV, dawa zako na huduma (kukaguliwa kwa mwili, vipimo vya kiwango cha virusi vya HIV 
(viral load), msaada wa ushauri na mhudumu anayeishi na HIV) utaendelea kupeanwa bila malipo 
yoyote kwako. 
 
For high blood pressure and diabetes, the lab tests at the beginning and end of the study will be free. 
However, you will pay for additional lab tests (if recommended by the clinician) during the course of the 
study. The cost for these tests are subsidized. You will also have to pay a small amount for your blood 
pressure and diabetes medications. 
Kwa ugonjwa wa Presha na ugonjwa wa Kisukari, vipimo vya maabara ya hapo mwanzoni na 
mwisho wa utafiti vitakuwa vya bure. Hata hivyo, utalipia vipimo vingine (ikiwa itapendekezwa na 
daktari) kwa wakati wa utafiti. Gharama ya vipimo hivi vimepunguzwa. Utalazimika pia kulipa 
pesa kidogo kwa ajili ya dawa zako za ugonjwa wa Presha na ugonjwa wa kisukari. 
 
You will not be giving up any of your legal rights by signing this consent form. 
Hautakuwa unakiuka haki yako yoyote ya kisheria kwa kutia sahihi kwenye fomu hii ya idhini. 
 
Payment/Compensation 
Malipo / Fidia 
 

 
48 
 
We will collect information every three months related to your microfinance activities including your 
saving and loaning activities. Each time we collect microfinance information, you will receive KES 300.  
How long will your part in the study last? 
Je, kushiriki kwako katika utafiti itakuwa kwa muda gani? 
 
If you enroll in this study, you will in the study for 18 months from the day you enroll. 
Ukijiandikisha katika utafiti huu, utakuwa katika utafiti kwa miezi 18 tangu siku ya kujiandikisha. 
 
What will happen if I miss or cannot attend one of my microfinance group meetings? 
Je! Ni nini itafanyika ikiwa nitakosa au siwezi kuhudhuria mojawapo ya mikutano ya kikundi 
changu cha mikopo midogo? 
 
If you do not attend a microfinance group meeting for any reason on a day that AMPATH staff are 
scheduled to conduct a visit, the staff will contact you to schedule a follow-up meeting for a time outside 
of your regularly scheduled group meeting.  
Ikiwa hautahudhuria mkutano wa kikundi cha mikopo midogo kwa sababu yoyote katika siku 
ambayo wafanyikazi wa AMPATH wamepangiwa kuwatembelea, wafanyikazi watawasiliana na 
wewe ili kupanga mkutano wa ufuatiliaji kwa muda ambao hauambatani na ratiba ya mikutano 
yenu ya kila mara kwa kikundi. 
 
Who is sponsoring this study?  
Je, ni nani anayefadhili utafiti huu? 
This research is funded by the National Institutes of Health in the United States. This means that the 
research team is being paid by the sponsor for doing the study. The researchers do not, however, have a 
direct financial interest with the sponsor or in the final results of the study.  
Utafiti huu unafadhiliwa na Taasisi za Kitaifa za Afya huko Merika (NIH). Hii inamaanisha kuwa 
timu ya utafiti inalipwa na mdhamini kwa kufanya utafiti. Watafiti kamwe, hata hivyo, hawana nia 
yoyote ya kifedha moja kwa moja na mdhamini au katika matokeo ya mwisho wa utafiti. 
 
Your alternatives to joining the study  
Njia zako mbadala za kujiunga na utafiti 
 
Your participation in this study is voluntary. You may choose to discontinue your participation at any time 
without penalty. Refusing to participate will not impact any care you receive from AMPATH or any other 
provider.  
Kushiriki kwako katika utafiti huu ni kwa hiari. Unaweza kuchagua kutamatisha kushiriki kwako 
wakati wowote bila adhabu. Kukataa kushiriki hakutaathiri huduma yoyote unayopokea kutoka 
AMPATH au kwa mhudumu mwengine yeyote. 

 
49 
 
 
Ending Consent 
Kukomesha idhini 
You may end your consent at any time. Information obtained and used before you end your consent will 
continue to be used for research. If you wish to end your consent, please let us know.  
Unaweza kukomesha idhini yako wakati wowote. Habari ambazo zimepatikana na kutumiwa kabla 
ya kukomesha idhini yako itaendelea kutumiwa katika utafiti. Ikiwa unataka kukomesha idhini 
yako, tafadhali tujulishe. 
Who do I call if I have questions or problems related to the study? 
Je! Niwasiliane na nani ikiwa nina maswali au shida zinazohusiana na utafiti? 
 
• 
Call the principal investigator: Juddy Wachira at 070-524- 2450 
• 
Call or contact the Moi University Institutional Research and Ethics Committee (IREC) if you 
have questions about your rights as a study participant. Contact IREC if you feel you have not been 
treated fairly or if you have other concerns. The IREC contact information is:  
Moi Teaching and Referral Hospital  
Institutional Research and Ethics Committee  
2nd floor. Door No. 219, 
P.O. Box. 3-30100  
Eldoret, Kenya 
Office line: 0787723677 
Email: irecmtrh@gmail.com or contact@irec.or.ke 
 
What does your signature on this consent form mean? 
Je, saini yako kwenye fomu hii ya idhini inamaanisha nini? 
Your signature on this form means: 
Saini yako kwenye fomu hii inamaanisha: 
• 
You have been informed about this study’s purpose, procedures, possible benefits and risks. 
Umejulishwa kuhusu kusudi la utafiti huu, taratibu, faida na hatari ambazo zinaweza 
kutokea. 
• 
You have been given the chance to ask questions before you sign. 
Umepewa fursa ya kuuliza maswali kabla ya kutia saini. 
• 
You have voluntarily agreed to be in this study.  
Umekubali kwa hiari kuwa katika utafiti huu. 
 
___________________________  _____________________________     __________ 
Print name of Adult Participant       Signature of Adult Participant                 Date       
Andika jina la mshiriki                  Sahihi ya mshiriki                                 Tarehe 
___________________________  _____________________________     __________ 
Print name of Person Obtaining Consent   Signature of Person Obtaining Consent   Date                              
Andika Jina la anayechukua idhini         Sahihi ya anayechukua  
 

 
50 
 
Appendix II: Adult Consent Form 2 
(For standard of care patients who are asked to enroll in Aim 1) 
 
Title of Research:  
 
Harambee: Integrated Community-Based HIV/NCD Care and  
Microfinance Groups in Kenya 
 
Principal Investigators:  
Juddy Wachira; Becky Genberg; Omar Galarraga 
 
IREC Approval #:  
 
0003054 
Sponsor: 
 
 
National Institute of Mental Health (NIMH) 
Version Date:   
23 February 2021 
 
What you should know about this study 
• 
You are being asked to join a research study.  
• 
This consent form explains the research study and your part in the study.  
• 
Please read it carefully and take as much time as you need.  
• 
You are a volunteer. You may choose not to take part in the study at all. If you choose to join 
the study, you may quit at any time. There will be no penalty if you decide to quit the study.  
• 
During the study, we will tell you right away if we learn any new information that might 
affect whether you wish to continue to be in the study. 
 
What is the purpose of research study? 
The purpose of this research study is to learn if offering HIV care and other health services in the 
community, instead of at a health facility, will help people who are living with HIV to live healthier lives. 
This research study also wants to learn if offering HIV care and other health services to people who are 
members of microfinance groups will help people who are living with HIV to live healthier lives.  
Why we are asking you to participate? 
1. You are being asked to participate in this study because: 
2. You are at least 18 years old 
3. You are an HIV patient  
4. You have been taking antiretroviral (ART) medications for the past 6 months or longer 
5. You receive care for HIV at an AMPATH HIV clinic 
6. You have an AMPATH identification number  
7. You do not have serious infections or illnesses that require immediate care or hospitalization 
8. You are not a member of a community ART group (CARG) 
9. You are not pregnant 
10. You are not currently participating in a microfinance group 
 
 
What will happen if you agree to participate in the study? 

 
51 
 
If you agree to participate in the study, the research team will ask you to complete a survey at the 
beginning (baseline) and at the end of the study (18 months). The survey will ask you questions about 
your household, access to food, access to HIV care, your medications, your community and your general 
health and well-being. 
The research team will also collect information about you from your AMPATH and other medical records 
throughout the study. This information will include information about you like your age and gender, 
diagnoses for HIV, HIV progression (CD4 cell count, HIV viral load), hypertension and/or diabetes, 
medication history, the number of times you attend your clinic appointments and the dates of these visits 
and appointments.  
Explanation of Procedures  
The following steps will be followed if you agree to participate in the study: 
Step 1: Baseline Assessment  
To be eligible for this study, you must meet the criteria set by the study. A member of the research team 
will confirm this information with you.  
If you agree to participate in the study today, we will confirm your HIV viral load from your AMPATH 
medical records and inform you of your HIV viral load once available. We will also perform a finger 
prick to test your blood sugar for diabetes. We may do another finger prick to confirm whether you have 
diabetes or not. We will tell you the result of the finger prick as soon as they are available. We will also 
measure your height, weight, temperature, waist circumference, and heart rate. To know if you have high 
blood pressure, we will measure your upper arm blood pressure as you sit quietly on a chair. If your blood 
pressure is high, we will measure your upper arm blood pressure again in 2 weeks and tell you the results 
as soon as they are available. 
Lastly, you will also complete a survey that will ask you questions about your household, food security, 
access to HIV care, your medications, your community and your general health and well-being.  
Step 2: Follow-up Assessment 
At the end of the study (18 months), we will draw blood for HIV viral load testing. We will run the viral 
load tests at a laboratory that is designated by your AMPATH clinic and inform you of the results once 
available. If you were diagnosed with diabetes at the beginning of the study, a finger prick will be 
conducted to test your blood sugar levels. This result will be available immediately and you will be 
informed of the test result immediately. If you were diagnosed with high blood pressure, we will also take 
measurements of your height, weight, waist circumference, pulse rate and measure your upper arm blood 
pressure as you sit quietly on the chair. You will also be asked to complete a follow-up survey at the end 
of the study (18 months). The survey will ask you questions about your household, food security, access 
to HIV care, your medications, your community and your general health and well-being.  
 
 
What happens if I decide to stop my treatment? 
If you choose to stop receiving care in your usual AMPATH clinic or Ministry of Health clinic before the 
end of the study, or if you decide you cannot complete all of the scheduled care visits:  

52 
•
As part of your routine care, you may be contacted by your clinic staff to understand why you
decided to stop care
•
Our research staff will reach out to you at the end of the study (18 months) for follow up
assessment (HIV viral load testing, blood sugar level testing if needed, blood pressure
measurement if needed, survey)
What happens if I become pregnant during the study? 
You cannot join this study if you are currently pregnant. However, it is possible that some female patients 
might become pregnant during the study. Women who are part of study and become pregnant while in the 
study will be asked to go back to clinic and attend their scheduled clinic visits. She must go to the clinic 
to get her HIV drugs as usual. We do not think there will be more risk to the pregnant woman or the 
unborn baby by participation in the study. However, this study will not directly help pregnant women or 
their babies. 
Risks of taking part in this study 
Blood draws 
Taking blood may cause some discomfort, bleeding, or bruising where the needle enters the body, light 
headedness, and in extremely rare cases, fainting or infection. However, the study staff are well trained to 
perform blood draws and we do not expect any complications to you from the procedure. 
Risk of losing confidentiality and increased stigma 
There is a risk of losing confidentiality (privacy). However, the clinic staff will be sure that your records 
are kept safe and your personal information is not given to anybody without permission. All of the 
information you provide and all of your responses to the survey will coded with a study ID and will never 
include your name. 
Benefits of taking part in the study 
We do not know if HIV care in the community keeps HIV-infected people as healthy as HIV-infected 
people who receive care at a health facility. It is possible that you may receive no benefit from being in 
this study. However, information learned from this study may help others who are infected with HIV live 
healthier lives.  
Confidentiality 
We will try very hard to keep your records confidential (private). We cannot guarantee absolute 
confidentiality. Your medical information could be shared if required by the law. Only a coded number, 
not your name, will be used to identify your information on study materials. Your name will not be used 
in any reports that the study may publish. A group of people may look at our research records to make 
sure they are complete and true. A group may also look at our records for data analysis (to see what the 
information people shared with us means). The groups looking at the records could be study investigators 
and their research partners, the Moi Institutional Research and Ethics Committee (IREC), the Indiana 
University Institutional Review Board (IRB), the Brown University Institutional Review Board (IRB), the 
Purdue University Institutional Review Board (IRB), the Johns Hopkins University Institutional Review 
Board (IRB), the study staff, or the sponsor (NIH). 
Data Sharing 

 
53 
 
We will not share the data from this study with anyone outside of our study staff team. 
Protecting your privacy during data collection 
Participation in this study involves multiple visits from AMPATH staff who will include a clinical 
officer, pharmacy technician, peer navigator, and social worker. Staff will conduct visits during your 
regular scheduled microfinance group and will meet with you in a location that is private and away from 
the other group members. Because we want to ensure your privacy during these visits, we will ask anyone 
nearby, either family members or neighbors, to relocate until after we are finished.   
Costs 
For HIV, your viral load tests will continue to be provided at no cost to you. 
For high blood pressure and diabetes, the lab tests at the beginning and end of the study will be free. 
However, you will pay for additional lab tests (if recommended by the clinician) during the course of the 
study. The cost for these tests are subsidized. You will also have to pay a small amount for your blood 
pressure and diabetes medications. 
You will not be giving up any of your legal rights by signing this consent form. 
Payment/Compensation 
You will be asked to complete one survey 2 times during the study: once in the beginning and once at the 
end of the study (at 18 months). You will receive KES 300 each time you complete the survey. 
 
How long will your part in the study last? 
If you enroll in this study, you will be asked to participate now and in 18 months from now. 
Who is sponsoring this study?  
This research is funded by the National Institutes of Health in the United States. This means that the 
research team is being paid by the sponsor for doing the study. The researchers do not, however, have a 
direct financial interest with the sponsor or in the final results of the study.  
Your alternatives to joining the study  
Your participation in this study is voluntary. You may refuse to participate and there will be no penalty for 
refusing. Refusing to participate will not impact any care you receive from AMPATH, or any other 
provider. You may choose to discontinue your participation at any time without penalty.  
 
Ending Consent 
You may end your consent at any time. Information obtained and used before you end your consent will 
continue to be used for research. If you wish to end your consent, please let us know.  
Who do I call if I have questions or problems related to the study? 
• 
Call the principal investigator: Juddy Wachira at 070-524- 2450 
• 
Call or contact the Moi University Institutional Research and Ethics Committee (IREC) if you 
have questions about your rights as a study participant. Contact IREC if you feel you have not been 
treated fairly or if you have other concerns. The IREC contact information is:  

54 
Address: 
Moi Teaching and Referral Hospital  
Institutional Research and Ethics Committee  
2nd floor. Door No. 219, 
P.O. Box. 3-30100  
Eldoret, Kenya 
Office line: 0787723677 
Email: irecmtrh@gmail.com or contact@irec.or.ke 
What does your signature on this consent form mean? 
Your signature on this form means: 
•
You have been informed about this study’s purpose, procedures, possible benefits and risks.
•
You have been given the chance to ask questions before you sign.
•
You have voluntarily agreed to be in this study.
___________________________  _____________________________     __________ 
Print name of Adult Participant       Signature of Adult Participant                 Date 
___________________________  _____________________________     __________ 
Print name of Person Obtaining Consent   Signature of Person Obtaining Consent   Date    

55 
Appendix III. Survey assessment tool 

Data Dictionary Codebook
Harambee Survey Assessment Tool (PID: 580)
07/29/2024 9:27pm
#
Variable / Field Name
Field Label
Field Note
Field Attributes (Field Type, Validation,
Choices, Calculations, etc.)
1
[harambee_study_id]
1. Respondent's Harambee Study ID
(Nambari ya kushiriki katika utafiti wa Harambee)
text, Identifier
2
[study_group_id]
Section Header: Research assistant should record this
information using the MF records, administrative worksheet and
AMRS data. The RA can ask the respondent to verify the
information. (Msaidizi wa utafiti anafaa kunukuu habari hii
akitumia rekodi za kikundi cha mikopo midogo, nakala za
uongozi katika chama pamoja na rekodi za AMRS. Msaidizi wa
utafiti anaweza kuuliza mhojiwa kudhibitisha habari zozote.)
2. Microfinance group Harambee Study ID
(Kitambulisho cha kikundi cha mikopo midogo)
text, Required, Identifier
3
[interview_date]
3. Encounter/Interview date
(Tarehe)
text (date_dmy)
4
[interviewer_name]
4. Interviewer name
(Jina la anayehoji)
dropdown
1
HBR01 (Jael Onyango)
2
HBR02 (Diana Chemowo)
3
HBR03 (Joshua Juma)
4
HBR04 (Mercy Akinyi)
5
HBR05 (Beryl Wafula)
6
HTR01 (Dan Aburi)
7
HTR02 (Susan Mutahi)
8
HTR03 (Abraham Kiplasima)
9
HTR04 (Catherine Kafu)
10
HTR05 (Susan Mastamet)
11
HBR06 (Sheila Kirwa)
12
HBR07 (Susan Mutahi)
13
HTR06 (Beryl Wafula)
5
[interview_time]
5. Time interview started
(Saa ya kuanza mahojiano)
text (time)
6
[metadata_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
7
[gender]
Section Header: Research assistant should read the following
introductory text before starting the survey: (Msaidizi wa utafiti
anapaswa kusoma maelezo yafuatayo ya utangulizi kabla ya
kuanza mahojiano:) Hello, my name is _______. I am a research
assistant for the Harambee study with AMPATH. I would like to
ask you some questions to learn about your experience
accessing healthcare and living in your community. I will ask you
questions about your physical health, your mental health, and
radio, Required
1
Male (Kiume)
2
Female (Kike)
Instrument: Meta-Data (metadata)
Instrument: Respondent Demographics (respondent_demographics)

how you feel when you receive care. I will also ask you questions
about your household and your community. Your answers will
help me understand what types of services people who are living
with HIV need to stay healthy. The questions will take about 20
minutes to complete. If you do not understand a question, you
can ask me to clarify. You can skip any question that you do not
want to answer. Please answer honestly. All of your answers will
be kept private. (Habari, jina langu ni ________. Mimi ni msaidizi
wa utafiti wa Harambee study katika AMPATH. Ningependa
kukuuliza maswali kadhaa ili kujua kuhusu uzoefu (experience)
wako katika kutafuta huduma pamoja na kuishi katika jamii
yako. Nitakuuliza maswali kuhusu afya yako ya kimwili, afya
yako ya kiakili, na jinsi unavyohisi unapoenda kupokea
matibabu. Pia, nitakuuliza maswali kuhusu nyumba na jamii
yako. Majibu yako yataniwezesha kuelewa ni aina zipi za
huduma ambazo watu wanaoishi na virusi vya HIV wanahitaji ili
kuwa na afya. Maswali haya yatachukua takriban dakika 20
kukamilisha. Ikiwa hauelewi swali, unaweza kuniuliza nieleze
zaidi. Unaweza kuruka swali lolote ambalo hutaki kujibu.
Tafadhali jibu kwa uaminifu. Majibu yako yote yatawekwa siri.)
Do you have any question(s)? (Je, una swali lolote?) OK, let's
begin. (Sawa, wacha tuanze.) Can you please tell me: (Je,
unaweza kuniambia:)
1. Gender
(Jinsia)
(Note: Fieldworker Observation)
(Kumbuka ni uchunguzi wa mtafiti)
8
[date_of_birth]
2. Date of birth
(Tarehe ya kuzaliwa)
text (date_dmy), Required
9
[marital_status]
3. What is your marital status
(Hali yako ya ndoa ni ipi)
radio, Required
1
Never married (Sijawahi oa/oleka)
2
Married (Nimeoa au oleka)
3
Divorce/Separated (Taliki/Tengana)
4
Widowed ( Mjane)
5
Other (Nyingine)
10
[marital_status_specif
y]
Show the field ONLY if:
[marital_status] = '5'
3a. Other marital status, specify
(Hali Hali yako ya ndoa nyingine, eleza)
text
11
[schooling_achieved]
4. What is the highest level of schooling you
achieved
(Je, ni kiwango kipi cha elimu ambacho ulifanikiwa
kufikia?)
radio, Required
1
None ( Hakuna)
2
Primary (Shule ya msingi)
3
Secondary (Shule ya upili)
4
Tertiary (Zaidi ya shule ya upili)
12
[house_head]
5. Are you the head of the household
(Je, wewe ndiye kiongozi wa nyumba yako)
If yes, END MODULE
radio, Required
1
Yes (Ndio)
2
No (La)
13
[relation_to_head]
Show the field ONLY if:
[house_head] = '2'
6. Relation to household head
(Una uhusiano upi na kiongozi wa nyumba)
radio
1
Spouse (Mchumba)
2
Child (Mtoto)
3
Other (Mwengine)

14
[relation_to_head_spec
ify]
Show the field ONLY if:
[relation_to_head] = '3'
6a. Other relation to household head, specify
(Uhusiano mwingine usiotajwa, eleza)
text
15
[respondent_demographi
cs_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
16
[healthcare_decision
s]
Section Header: I would like to ask you some questions about
health insurance. Please answer honestly and to the best of your
knowledge. All responses are confidential. (Ningependa
kukuuliza maswali kadhaa kuhusu bima ya afya. Tafadhali jibu
kwa uaminifu na kulingana na ufahamu wako. Majibu yote ni ya
siri.)
1. Who makes the main decisions regarding
healthcare for your household? For example where
to seek healthcare, when to seek healthcare, etc
(Je, ni nani katika nyumba yako hufanya maamuzi
kuhusu mambo ya afya kama vile mahali na wakati
wa kutafuta huduma ya afya)
radio
1
Self (Wewe mwenyewe)
2
Partner/Spouse
(Mpenzi/Mchumba/Mume/Mke wako)
3
Other (Nyingine)
17
[other_decision_make
r]
Show the field ONLY if:
[healthcare_decisions] =
'3'
1a. Who else apart from the ones listed above
makes the decisions regarding healthcare for your
household, specify
(Je, ni nani mwingine hufanya maamuzi kuhusu
mambo ya afya kama vile mahali na wakati wa
kutafuta huduma ya afya ambaye hajatajwa, eleza)
text
18
[enrolled_in_nhif]
2. Have you ever been enrolled in NHIF (National
Hospital Insurance Fund)
(Je, umewahi kusiajiliwa kwa bima ya NHIF (Bima ya
Afya ya Kitaifa)
radio
1
Yes (Ndio)
2
No (La)
19
[nhif_first_enrolled]
Show the field ONLY if:
[enrolled_in_nhif] = '1'
2a. Do you remember when you were first enrolled
in NHIF
(Je unakumbuka ni lini ulijiandikisha kwa NHIF)
radio
1
Yes (Ndio)
2
No (La)
98
Don't know (Sijui)
20
[when_enrolled_in_nhi
f]
Show the field ONLY if:
[nhif_first_enrolled] = '1'
2b. When were you enrolled in NHIF
(Ni lini ulijiandikisha kwa NHIF)
text (date_dmy)
21
[nhif_super_cover]
Show the field ONLY if:
[nhif_first_enrolled] = '1'
2c. Do you currently have an NHIF cover
(Je kwa sasa una bima ya Afya ya NHIF)
radio
1
Yes (Ndio)
2
No (La)
98
Don't know (Sijui)
22
[remember_nhif_use]
Show the field ONLY if:
[nhif_super_cover] = '1'
2d. Do you remember the number of times you
have used NHIF in the past 12 months
(Unakumbuka ni mara ngapi umetumia NHIF kwa
miezi 12 iliyopita)
radio
1
Yes (Ndio)
2
No (La)
98
Don't know (Sijui)
Instrument: Health Insurance (health_insurance)

23
[times_used_nhif_pst12
mnths]
Show the field ONLY if:
[remember_nhif_use] =
'1'
2e. How many times have you used NHIF to cover
health expenses of your household members in the
past 12 months
(Je, ni mara ngapi umetumia NHIF kulipia gharama
ya matibabu ya watu wa nyumba yako kwa miezi 12
iliyopita)
text
24
[reason_no_nhif_cove
r]
Show the field ONLY if:
[nhif_super_cover] = '2'
2f. Why don't you have NHIF coverage
(Ni kwa nini hauna bima ya afya ya NHIF)
radio
1
Lack of finances (Ukosefu wa fedha)
2
Unsure how to access NHIF ( Sina
uhakika jinsi ya kupata bima ya NHIF)
3
See no benefit (Sioni faida yake)
4
Other (Nyingine)
25
[no_nhif_cover_specif
y]
Show the field ONLY if:
[reason_no_nhif_cover]
= '4'
2g. Other reason for no NHIF coverage, specify
(Sababu nyingine ya kutokuwa na bima ya NHIF,
eleza)
text
26
[other_cover]
3. Are you currently covered by any other health
insurance apart from NHIF
(Je, kwa sasa una bima yoyote nyingine ya afya
kando na NHIF)
radio
1
Yes (Ndio)
2
No (La)
98
Don't know (Sijui)
27
[other_cover_specify]
Show the field ONLY if:
[other_cover] = '1'
3a. Please indicate the health insurance cover
(Tafadhali taja jina la bima hiyo)
text
28
[health_insurance_comp
lete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
29
[close_pple_yu_can_cou
nt_on]
Section Header: I would like to know about the type of social
support that is available to you. Please tell me how much you
agree or disagree with the following statements. Sasa,
ningependa kujua kuhusu msaada wa kijamii unaopatikana
kwako. Tafadhali nieleze jinsi gani unavyokubali au
kutokubaliana na maelezo yafuatayo.
1. How many people are so close to you that you
can count on them if you have great personal
problems
(Je, ni watu wangapi wako na uhusiano wa karibu
nawewe na unaweza wategemea ukiwa na shida
yeyote ya kibinafsi)
radio
1
None (Hakuna)
2
1-2 (Mmoja hadi wawili)
3
3-5 Watatu hadi watano)
4
5+ (Zaidi ya watano)
30
[show_interest_in_what
_you_do]
2. How much interest and concern do people show
in what you do
(Je watu huwa na kiasi gani cha haja na vitu
ambavyo huwa unafanya)
radio
1
None (Hakuna)
2
Little (Kidogo)
3
Uncertain (Sina uhakika)
4
Some (Kiasi)
Instrument: OSLO Social Support Scale -3 (oslo_social_support_scale_3)

5
A lot (Sana)
31
[get_help_from_neighbo
urs]
3. How easy is it to get practical help from
neighbors if you should need it
(Je ni rahisi kiasi gani kupata usaidizi kutoka kwa
majirani iwapo utahitaji usaidizi)
radio
1
Very difficult (Ngumu sana)
2
Difficult (Ngumu)
3
Possible (Inawezekana)
4
Easy (Rahisi)
5
Very easy (Rahisi sana)
32
[oslo_social_support_s
cale_3_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
33
[health_in_general]
Section Header: Now I would like to ask you a few questions
about your health recently. (Sasa ningependa kukuuliza maswali
chache kuhusu afya yako hivi karibuni.)
1. In general would you say your health is
(Kwa ujumla, unaweza kusema afya yako ni)
radio
1
Good (Nzuri)
2
Neither good nor bad (Kadri)
3
Poor (Mbaya)
34
[bodily_pain_in_past_3
0days]
2. How much bodily pain have you generally had
during the past 30 days
(Je, umekuwa na maumivu ya kimwili kiasi gani kwa
siku 30 zilizopita)
radio
1
None (Hakuna)
2
Very mild (Kidogo sana)
3
Mild (Kidogo)
4
Moderate (Kiasi)
5
Severe (Kali)
6
Very Severe (Kali sana)
35
[paint_interfere_with_
work]
3. During the past 30 days, how much did pain
interfere with your normal work, including both
work outside the home and housework
(Katika siku 30 zilizopita, je, ni kwa kiasi gani
maumivu iliingilia kati kwenye kazi zako za kawaida,
ukijumlisha kazi za nje ya boma na zile za
kinyumbani)
radio
1
Not at all (Hapana kabisa)
2
A little bit (Kidogo kiasi)
3
Moderately (Kiasi)
4
Quite a bit (Sana)
5
Extremely (Pakubwa sana)
36
[adapted_medical_outco
mes_study_hiv_health_s
urvey_m_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
37
[pleasure_in_doing_thi
ngs]
Section Header: Over the last 2 weeks, how often have you been
bothered by the following problems (Kwa muda wa wiki mbili
umekumbwa na haya matatizo)
1a. Little interest or pleasure in doing things
(Kukosa hamu au kutofurahia kufanya kazi)
radio (Matrix)
0
Not at all (Hakuna Kabisa)
1
1-3 days in a week (Siku 1-3 kwa wiki)
2
4-5 days in a week (Siku 4-5 kwa wiki)
Instrument: Adapted Medical Outcomes Study HIV Health Survey (MOS-HIV)
(adapted_medical_outcomes_study_hiv_health_survey_m)
Instrument: Patient Health Questionnaire-2 (patient_health_questionnaire2)

3
6-7 days in a week (Siku 6-7 Kwa wiki)
38
[feeing_depressed]
1b. Feeling down, depressed or hopeless (Kujihisi
mnyonge, kosononeka au kusosa matumaini)
radio (Matrix)
0
Not at all (Hakuna Kabisa)
1
1-3 days in a week (Siku 1-3 kwa wiki)
2
4-5 days in a week (Siku 4-5 kwa wiki)
3
6-7 days in a week (Siku 6-7 Kwa wiki)
39
[worried_or_anxious]
Section Header: 2. Over the last 2 weeks, how often have you
been bothered by any of the following problems (Kwa wiki mbili
zilizopita umekumbwa na haya matatizo)
2a. Feeling worried or anxious (Kujihisi kuwa na
wasiwasi au shauku)
radio (Matrix)
0
Not at all (Hakuna kabisa)
1
Several days (Siku kadhaa)
2
More than half the days (Zaidi ya nusu
ya siku)
3
Nearly every day (Karibu kila siku)
40
[unable_to_stop_worryi
ng]
2b. Being unable to stop yourself from worrying
(Kukosa uwezo wa kujizuia kuwa mwenye wasiwasi)
radio (Matrix)
0
Not at all (Hakuna kabisa)
1
Several days (Siku kadhaa)
2
More than half the days (Zaidi ya nusu
ya siku)
3
Nearly every day (Karibu kila siku)
41
[patient_health_questi
onnaire2_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
42
[days_missed_dose_in_p
st4dys]
Section Header: Most people with HIV have many pills to take at
different times during the day. Many people find it hard to
always remember to take their pills. (Baadhi ya watu ambao
wanaishi na virusi vya HIV huwa wana tembe nyingi za kumeza
kwa nyakati tofauti kwa siku. Wengi hupata ugumu kila mara
kukumbuka kuzimeza tembe zao.) I would like to ask you about
the HIV medications that you took over the last four days.
(Ningependa kukuuliza kuhusu dawa za HIV ambazo
umechukua kwa siku nne zilizopita.)
1. During the past 4 days, on how many days have
you missed taking all your doses? Select only one
response
(Katika siku 4 zilizopita, ni siku ngapi umekosa
kuchukua kipimo cha dawa zako zote inavyopaswa?
Chagua jibu moja tu)
radio
1
None (Hakuna)
2
One day (Siku moja)
3
Two days (Siku mbili)
4
Three days (Siku tatu)
5
Four days (Siku nne)
43
[follow_schedule_in_ps
t4dys]
2. Most HIV medications need to be taken on a
schedule. How often did you follow your specific
schedule over the last 4 days
(Dawa nyingi za virusi vya HIV zahitaji kuchukuliwa
kwa masaa inayohitajika (ratiba). Ni mara ngapi
ulimeza dawa zako kwa masaa inyaohitajika kwa
siku 4 zilizopita)
radio
1
Never (Kamwe)
2
Some of the time (Saa zingine)
3
About half of the time (Karibu nusu ya
kila mara)
4
Most of the time (Mara nyingi)
5
All of the time (Wakati wote)
Instrument: Adapted ACTG Self Report Adherence
Questionnaire (adapted_actg_self_report_adherence_questionnaire)

44
[meds_have_special_ins
trns]
3. Do any of your anti-HIV medications have special
instructions, such as "take with food" or "on an
empty stomach" or "with plenty of fluids"
(Je, dawa zako zozote za virusi vya HIV zina maagizo
maalum, kama vile meza "pamoja na chakula" au
"kwenye tumbo tupu" au "na maji mengi")
radio
1
Yes (Ndio)
2
No (La)
45
[follow_instrns_in_pas
t4dys]
Show the field ONLY if:
[meds_have_special_ins
trns] = '1'
3a. If Yes, how often did you follow those special
instructions over the last four days
(Ikiwa Ndio, Je, ni mara ngapi ulifuata hayo maagizo
maalum kwa siku nne zilizopita
radio
1
Never (Kamwe)
2
Some of the time (Saa zingine)
3
About half of the time (Karibu nusu ya
kila mara)
4
Most of the time (Mara nyingi)
5
All of the time (Wakati wote)
46
[missed_any_dose_in_la
st_12mnths]
Section Header: Now, I would like to ask you just a few more
general questions about how you have been taking your
medication. (Sasa ningependa kukuuliza maswali machache ya
kijumla kuhusu jinsi umekuwa ukimeza madawa yako)
4. Have you missed a dose of any of your
medications in the last 12 months
Je, kwa miezi kumi na mbili iliyopita, umakosa
kumeza hata kipimo kimoja cha madawa yako
yesno
1
Yes
0
No
Custom alignment: RH
47
[period_missed_meds]
Show the field ONLY if:
[missed_any_dose_in_la
st_12mnths] = '1'
4a. When was the last time you missed any of your
medications
(Je, ni lini mwisho ulikosa kumeza dawa yako
yoyote)
dropdown
1
1. Within the past week (Mnamo wiki
iliyopita)
2
2. 1 to less than 2 weeks ago (Wiki 1
lakini chini ya wiki 2 zilizopita)
3
3. 2 to less than 4 weeks ago (Wiki 2
lakini chini ya wiki 4 zilizopita)
4
4. 1 to less than 3 months ago (Mwezi
moja lakini chini ya miezi 3 iliyopita)
5
5. More than 3 months ago (Zaidi ya
miezi 3 iliyopita)
6
6. Never skip medications (Kamwe
sijakosa dawa zangu)
48
[away_from_home]
Show the field ONLY if:
[period_missed_meds]
<> '6'
Section Header: 5. People may miss taking their HIV
medications for various reasons. How often have you missed
taking your medications in the past 30 days, because you: (Select
one response for each question) (Ni mara ngapi umekosa
kumeza dawa zako kwa siku 30 zilizopita, kwa sababu wewe:
(Chagua jibu moja kwa kila swali)
1. Were away from home (Ulikuwa mbali na
nyumbani)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
49
[busy_with_other_thing
s]
Show the field ONLY if:
[period_missed_meds]
<> '6'
2. Were busy with other things (Ulikuwa
umeshughulika na vitu vingine)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
50
[simply_forgot]
3. Simply forgot (Ulikuwa umesahau tu)
radio (Matrix)

Show the field ONLY if:
[period_missed_meds]
<> '6'
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
51
[too_many_pills_to_tak
e]
Show the field ONLY if:
[period_missed_meds]
<> '6'
4. Had too many pills to take (Ulikuwa na tembe
nyingi sana za kumeza)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
52
[avoid_side_effects]
Show the field ONLY if:
[period_missed_meds]
<> '6'
5. Wanted to avoid side effects (Ulikuwa unataka
kuepukana na athari mbaya)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
53
[didnt_want_other_to_n
otice]
Show the field ONLY if:
[period_missed_meds]
<> '6'
6. Did not want others to notice you taking
medication (Ulikuwa hutaki wengine wakuone
ukimeza dawa)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
54
[change_in_daily_routi
ne]
Show the field ONLY if:
[period_missed_meds]
<> '6'
7. Had a change in daily routine (Ulikuwa na
mabadiliko katika taratibu yako ya kila siku)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
55
[felt_drugs_were_toxi
c]
Show the field ONLY if:
[period_missed_meds]
<> '6'
8. Felt like the drug was toxic/harmful (Ulikuwa
unahisi kwamba dawa ilikuwa na sumu/hatari)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
56
[slept_throu_dose_tim
e]
Show the field ONLY if:
[period_missed_meds]
<> '6'
9. Fell asleep/slept through dose time (Ulikuwa
umelala/ukalala hadi wakati wa kumeza dawa
ukapita)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
57
[felt_sick_or_ill]
10. Felt sick or ill (Ulikuwa unajiskia mgonjwa)
radio (Matrix)

Show the field ONLY if:
[period_missed_meds]
<> '6'
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
58
[felt_depressed]
Show the field ONLY if:
[period_missed_meds]
<> '6'
11. Felt depressed/overwhelmed (Ulikuwa unahisi
kusongwa au kuzidiwa na mawazo)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
59
[prob_taking_meds_spec
_time]
Show the field ONLY if:
[period_missed_meds]
<> '6'
12. Had problems taking pills at specified times
(Ulikuwa na tatizo la kumeza tembe kwa nyakati
maalum)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
60
[ran_out_of_pills]
Show the field ONLY if:
[period_missed_meds]
<> '6'
13. Ran out of pills (Ulikuwa umeishiwa na tembe
zako)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
61
[felt_healthy]
Show the field ONLY if:
[period_missed_meds]
<> '6'
14. Felt healthy (Ulikuwa unajiskia mzima)
radio (Matrix)
1
Never (Kamwe)
2
(1-2 times) Rarely (Nadra)
3
(3-5 times) Sometimes (Wakati
mwingine)
4
(> 5 times) Often (Mara nyingi)
62
[adapted_actg_self_rep
ort_adherence_question
naire_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
63
[tested_and_found_high
_bp]
a) Have you been tested and found that you have
high blood pressure
(Je, umewahi pimwa na ukapatikana ya kwamba
uko na ugonjwa wa pressure)
radio
1
Yes (Ndio)
2
No (La)
Custom alignment: RH
64
[taking_meds_for_high_
bp]
b) Are you currently taking medications for your
high blood pressure
radio
1
Yes (Ndio)
Instrument: Extent of Nonadherence (DOSE-Nonadherence)
Questionnaire (extent_of_nonadherence_dosenonadherence_questionna)

Show the field ONLY if:
[tested_and_found_high
_bp] = '1'
(Je, kwa sasa unameza dawa za ugonjwa wa
pressure)
2
No (La)
Custom alignment: RH
65
[missed_my_medicine]
Show the field ONLY if:
[taking_meds_for_high_
bp] = '1'
Section Header: 1. In order for medication for hypertension
(pressure) to work, people have to take it as prescribed. For one
reason or another, many people can't or don't always take all of
their medication as prescribed. We want to know how often you
have missed your medication(s) for hypertension (pressure). (Ili
dawa za ugonjwa wa pressure zifanye kazi, watu wanapaswa
kuzimeza kama ilivyoagizwa. Kwa sababu moja au nyingine,
watu wengi hawawezi au kwa mara nyingi hawazimezi dawa
kama ilivyoagizwa. Tunataka kujua ni mara ngapi umekosa
kumeza dawa zako za ugonjwa wa pressure.
Over the past seven days, I missed my medicine
(Kwa siku saba zilizopita, nilikosa kumeza dawa
yangu)
radio (Matrix)
1
(0) None of the time (Hakuna wakati)
2
(1-2) A little of the time (Wakati kidogo)
3
(3-4) Some of the time (Saa zingine)
4
(5-6) Most of the time (Mara nyingi)
5
(7) Every time (Kila wakati)
66
[skipped_a_dose]
Show the field ONLY if:
[taking_meds_for_high_
bp] = '1'
Over the past seven days, I skipped a dose of my
medicine (Kwa siku saba zilizopita, nilikosa kumeza
kipimo cha dawa yangu kimaksudi)
radio (Matrix)
1
(0) None of the time (Hakuna wakati)
2
(1-2) A little of the time (Wakati kidogo)
3
(3-4) Some of the time (Saa zingine)
4
(5-6) Most of the time (Mara nyingi)
5
(7) Every time (Kila wakati)
67
[didnt_take_a_dose]
Show the field ONLY if:
[taking_meds_for_high_
bp] = '1'
Over the past seven days, I did not take a dose of
my medicine (Kwa siku saba zilizopita, Sikumeza
kipimo chochote cha dawa yangu bila kusudia)
radio (Matrix)
1
(0) None of the time (Hakuna wakati)
2
(1-2) A little of the time (Wakati kidogo)
3
(3-4) Some of the time (Saa zingine)
4
(5-6) Most of the time (Mara nyingi)
5
(7) Every time (Kila wakati)
68
[tested_and_found_diab
etes]
c) Have you been tested and found that you have
diabetes
(Je, umewahi kupimwa na kupatikana ya kwamba
uko na ugonjwa wa kisukari)
radio
1
Yes (Ndio)
2
No (La)
Custom alignment: RH
69
[taking_meds_for_diabe
tes]
Show the field ONLY if:
[tested_and_found_diab
etes] = '1'
d) Are you currently taking medications for your
diabetes
(Je, kwa sasa unameza dawa za ugonjwa wa
kisukari)
radio
1
Yes (Ndio)
2
No (La)
70
[missed_diabetes_med
s]
Show the field ONLY if:
[taking_meds_for_diabe
tes] = '1'
Section Header: 2. In order for anti-diabetic medication(s) to
work, people have to take it as prescribed. For one reason or
another, many people can't or don't always take all of their
medication as prescribed. We want to know how often you have
missed your anti-diabetic medication(s). (Ili dawa za ugonjwa wa
kisukari zifanye kazi, watu wanapaswa kuzimeza kama
ilivyoagizwa. Kwa sababu moja au nyingine, watu wengi
hawawezi au kwa mara nyingi hawazimezi dawa kama
ilivyoagizwa. Tunataka kujua ni mara ngapi umekosa kumeza
dawa zako za ugonjwa wa kisukari.)
Over the past 7 days, I missed my medicine (Kwa
siku saba zilizopita, nilkosa kumeza dawa yangu)
radio (Matrix)
1
None of the time (Hakuna wakati)
2
A little of the time (Wakati kidogo)
3
Some of the time (Saa zingine)
4
Most of the time (Mara nyingi)
5
Every time (Kila wakati)
71
[skipped_dose_for_diab
etes]
Over the past 7 days, I skipped a dose of my
medicine (Kwa siku saba zilizopita, nilikosa kumeza
radio (Matrix)

Show the field ONLY if:
[taking_meds_for_diabe
tes] = '1'
kipimo cha dawa yangu kimaksudi)
1
None of the time (Hakuna wakati)
2
A little of the time (Wakati kidogo)
3
Some of the time (Saa zingine)
4
Most of the time (Mara nyingi)
5
Every time (Kila wakati)
72
[didnt_take_diabetes_m
eds]
Show the field ONLY if:
[taking_meds_for_diabe
tes] = '1'
Over the past 7 days, I did not take a dose of my
medicine (Kwa siku saba zilizopita, sikumeza kipimo
chochote cha dawa yangu bila kusudia)
radio (Matrix)
1
None of the time (Hakuna wakati)
2
A little of the time (Wakati kidogo)
3
Some of the time (Saa zingine)
4
Most of the time (Mara nyingi)
5
Every time (Kila wakati)
73
[extent_of_nonadherenc
e_dosenonadherence_que
stionna_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
74
[hard_to_receive_care_
pst6mths]
1. In the past 6 months, has it ever been hard for
you to receive care for HIV
(Kwa miezi 6 iliyopita, je, imewahi kuwa ngumu
kwako kupokea matibabu ya HIV)
radio
1
Yes (Ndio)
2
No (La)
98
Don't Know (Sijui)
99
Refuse (Kataa)
Custom alignment: RH
75
[challenges_past_6mnth
s]
Show the field ONLY if:
[hard_to_receive_care_p
st6mths] = '1' or [hard_t
o_receive_care_pst6mth
s] = '98'
2. In the past six months, have you encountered
challenges with getting care for
other health problems (other than HIV)?
(Kwa miezi sita iliyopita, umekumbana na
changamoto za kiafya (ijapokuwa HIV))
radio
1
Yes (Ndio)
2
No (La)
Custom alignment: RH
76
[challenge_receiving_c
are]
Show the field ONLY if:
[challenges_past_6mnth
s] = '1'
2a. What are some of these challenges
(je, ni nini baadhi ya hizi changamoto)
checkbox
1
challenge_receiving_care___1
1.
Transportat
was too
difficult or
expensive
(Usafiri
ulikuwa
mgumu san
au ghali)
2
challenge_receiving_care___2
2. I didn't ha
enough
money to pa
for care
(Sikuwa na
pesa za
kutosha za
Instrument: Barriers to Accessing Care (barriers_to_accessing_care)

kulipia
huduma)
3
challenge_receiving_care___3
3. I forgot
about my
scheduled
appointmen
(Nilisahau
kuhusu tare
ya kliniki
ilivyopangw
4
challenge_receiving_care___4
4. My last
experience
was not
pleasant
(Sikufurahia
experience
yangu ya
mwisho
nilipokuwa
natafuta
matibabu)
5
challenge_receiving_care___5
5. Other
(Nyingine)
77
[other_challenge_to_ge
tting_to_facility]
Show the field ONLY if:
[challenge_receiving_car
e(5)] = '1'
If there is other challenge of getting to the facility,
specify
text
78
[demands_that_hinder_c
are]
Show the field ONLY if:
[hard_to_receive_care_p
st6mths] = '1' or [hard_t
o_receive_care_pst6mth
s] = '98'
3. In the past 6 months, has work and/or family
demands made it difficult for you to receive care
(Kwa miezi sita iliyopita, je mahitaji ya kikazi ama ya
kifamilia yamefanya iwe ngumu kwako kupokea
matibabu ya virusi vya HIV)
radio
1
Yes (Ndio)
2
No (La)
Custom alignment: RH
79
[demands_hindering_car
e]
Show the field ONLY if:
[demands_that_hinder_
care] = '1'
3a. What are some of these demands?
(je, ni nini baadhi ya haya mahitaji?)
checkbox
1
demands_hindering_care___1
1. My family
needed
money that
I would
have spent
on
receiving
care
(Familia
yangu
walihitaji
pesa
ambazo
ningetumia
kupokea
matibabu)
2
demands_hindering_care___2
2. I had to
work
during the

time I was
supposed
to go for
care
(Nililazimika
kufanye
kazi wakati
ambao
nilifaa
kuendea
matibabu)
3
demands_hindering_care___3
3. I had a
family
obligation
e.g., event,
funeral
(Nilikuwa
na
majukumu
ya kifamilia
k.v.
sherehe,
matanga)
4
demands_hindering_care___4
4. My family
would find
out that I
had HIV if I
went for
care
(Familia
yangu
ingegundua
kuwa
ninaishi na
virusi vya
HIV endapo
ningeendea
matibabu)
5
demands_hindering_care___5
5. Other
(Nyingine)
80
[other_work_family_dem
ands]
Show the field ONLY if:
[demands_hindering_ca
re(5)] = '1'
3b. Other family/work demands that hinder care,
specify
text
81
[clinic_issues_got_in_
the_way]
Show the field ONLY if:
[hard_to_receive_care_p
st6mths] = '1' or [hard_t
o_receive_care_pst6mth
s] = '98'
4. In the past 6 months, were there issues that got
in the way of you receiving care
(Kwa miezi sita iliyopita, kumekuwa na maswala
ambayo yalikuzuia kupokea huduma )
radio
1
Yes (Ndio)
2
No (La)
Custom alignment: RH
82
[list_of_clinic_issue
s]
Show the field ONLY if:
4a. What were these issues
(Je ni nini baadhi ya haya maswala)
checkbox
1
list_of_clinic_issues___1
1. Lack of the
medications I

[clinic_issues_got_in_the
_way] = '1'
needed
(Ukosefu wa
ma dawa
nilizohitaji)
2
list_of_clinic_issues___2
2. The
doctors or
providers
were not
there
(Madaktari au
wahudumu
wa afya
hawakuwepo)
3
list_of_clinic_issues___3
3. The staff
was not nice
(Wahudumu
hawakuwa
wazuri)
4
list_of_clinic_issues___4
4. The care
was not good
(Huduma
haikuwa
nzuri)
5
list_of_clinic_issues___5
5. The
community
would find
out that I had
HIV if I went
for care (Jamii
ingegundua
kuwa ninaishi
na virusi vya
HIV endapo
ningeendea
matibabu)
6
list_of_clinic_issues___6
6. Other
(Nyingine)
83
[other_clinical_issue
s]
Show the field ONLY if:
[list_of_clinic_issues(6)]
='1'
4b. What other clinical issues got in the way, specify
text
84
[medical_issues_in_the
_way]
Show the field ONLY if:
[hard_to_receive_care_p
st6mths] = '1' or [hard_t
o_receive_care_pst6mth
s] = '98'
5. In the past 6 months, have you personally
experienced any medical issues that got in the way
of you receiving care
(Kwa miezi 6 zilizopita mekuwa na sababu zozote za
kiafya ambazo zilikuzuia kupokea huduma)
radio
1
Yes (Ndio)
2
No (La)
Custom alignment: RH
85
[medical_reasons]
Show the field ONLY if:
[medical_issues_in_the_
way] = '1'
5a. What were these medical reasons
(Je ni nini baadhi ya sababu hizi za kiafya)
checkbox
1
medical_reasons___1
1. I felt too sick
to go to the
clinic (Nilihisi

mgonjwa sana
kwenda kliniki)
2
medical_reasons___2
2. My medicine
was not
working (Dawa
zangu hazikuwa
zikifanya vizuri)
3
medical_reasons___3
3. I was
experiencing
side effects
from the
medicine
(Nilikuwa
nikipata athari
kutokana na
dawa zenyewe)
4
medical_reasons___4
4. I felt well and
didn't need care
(Nilihisi vizuri
na sikuhitaji
huduma)
5
medical_reasons___5
5. I didn't want
to keep taking
medicine
(Sikutaka
kuendelea
kutumia dawa)
6
medical_reasons___6
6. I was taking
too many pills a
day (Nilikuwa
nameza tembe
nyingi kwa siku
7
medical_reasons___7
7. Other
(Nyingine)
86
[other_medical_issue
s]
Show the field ONLY if:
[medical_reasons(7)]='1'
5b. What other medical issues got in the way,
specify
text
87
[other_reasons_pst_6mt
hs]
Show the field ONLY if:
[hard_to_receive_care_p
st6mths] = '1' or [hard_t
o_receive_care_pst6mth
s] = '98'
6. Please describe what other reasons got in the
way of you receiving care in the past 6 months
(Tafadhali eleza sababu gani zinginezo zilizokuzuia
kupokea huduma katika miezi 6 iliyopita)
text
88
[barriers_to_accessing
_care_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
Instrument: Patient Satisfaction Survey (patient_satisfaction_survey)

89
[courtesy_and_respec
t]
Section Header: Now I would like to hear about your experience
receiving care at AMPATH health facilities. Please answer
honestly and to the best of your knowledge. All responses are
confidential. (Sasa, ningependa kusikia jinsi umekuwa ukipokea
huduma katika kliniki za AMPATH. Tafadhali jibu kwa uaminifu
na kulingana na ufahamu wako. Majibu yote ni ya siri.)
1. When you go to receive HIV care, how often do
staff at the health facility treat you with courtesy
and respect
radio (Matrix)
1
All the time (Kila wakati)
2
A lot of the time (Mara nyingi)
3
Some of the time (Wakati mwingine)
4
None of the time (Hakuna hata wakati)
90
[listen_carefully]
2. When you go to receive HIV care, how often do
doctors or health providers listen carefully to you
radio (Matrix)
1
All the time (Kila wakati)
2
A lot of the time (Mara nyingi)
3
Some of the time (Wakati mwingine)
4
None of the time (Hakuna hata wakati)
91
[ask_for_your_opinio
n]
3. When you go to receive HIV care, how often do
doctors or health providers ask for your opinion
regarding your healthcare
radio (Matrix)
1
All the time (Kila wakati)
2
A lot of the time (Mara nyingi)
3
Some of the time (Wakati mwingine)
4
None of the time (Hakuna hata wakati)
92
[satisfied_with_time_g
iven]
4. When you go to receive HIV care, how often are
you satisfied with the amount of time your
doctor/provider spends with you
radio (Matrix)
1
All the time (Kila wakati)
2
A lot of the time (Mara nyingi)
3
Some of the time (Wakati mwingine)
4
None of the time (Hakuna hata wakati)
93
[private_and_confident
ial]
Section Header: Please tell me how much you agree or disagree
with the following statements. (Tafadhali niambie ni kwa kiasi
gani unakubaliana au haukubaliani na mambo yafuatayo.)
5. The providers can be trusted to keep my medical
information private and confidential
radio (Matrix)
1
Agree (Nakubali)
2
Neither agree nor disagree (Sikubali
wala sikatai)
3
Disagree (Sikubali)
94
[treat_people_same_wa
y]
6. Health workers treat people with HIV the same
way as they treat people with other illnesses
radio (Matrix)
1
Agree (Nakubali)
2
Neither agree nor disagree (Sikubali
wala sikatai)
3
Disagree (Sikubali)
95
[satisfation_with_the_
care]
7. Overall, how satisfied are you with the HIV care
you receive
(Kwa ujumla, unaridhika kiasi gani na huduma ya
HIV unayopokea)
radio
1
Very satisfied (Nimeridhika sana)
2
Satisfied (Nimeridhika)
3
Not satisfied (Sijaridhika)
Custom alignment: RH
96
[patient_satisfaction_
survey_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete

97
[hiv_was_a_punishmen
t]
Section Header: Now I would like to hear about your experience
living with HIV. Please feel free to share your experience. All of
your responses are confidential. (Sasa ningependa kusikia
kuhusu uzoefu wako wa kuishi na virusi vya HIV. Tafadhali shiriki
kwa kiasi kikubwa au kidogo jinsi unavyopenda. Majibu yako
yote ni ya siri.) In the past thirty days, how often have the
following statements applied to you: (Katika siku thelathini
zilizopita, ni mara ngapi taarifa zifuatazo zimekuhusu:)
1. In the past thirty days, how often have you felt
that having HIV was a punishment for things I had
done in the past.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
98
[avoided_coz_if_hiv_st
atus]
2. In the past thirty days, how often have you felt
that people were avoiding me because of my HIV
status.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
99
[lose_friends_coz_of_h
iv]
3. In the past thirty days, how often have you
feared that I would lose my friends if they learnt
about my having HIV.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
100 [treated_differentl_co
z_hiv]
4. In the past thirty days, how often have you felt
like people that I know were treating me differently
because of my HIV status.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
101 [looked_down_coz_of_hi
v]
5. In the past thirty days, how often have you felt
like people looked down on me because I have HIV.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
102 [no_relations_coz_of_h
iv]
6. In the past thirty days, how often have you
avoided sexually interacting with my
wife/husband/girlfriend/boyfriend because most
people don't want a relationship with someone
with HIV.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
103 [avoided_situations]
7. In the past thirty days, how often have you
avoided a situation because I worried of people
knowing I have HIV.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
104 [embarrassed_coz_of_hi
v]
8. In the past thirty days, how often were you
embarrassed about having HIV.
radio (Matrix)
Instrument: Felt Stigma Questionnaire (felt_stigma_questionnaire)

1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
105 [keep_status_a_secre
t]
9. In the past thirty days, how often have you felt
that keeping my HIV status a secret was important.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
106 [home_life_disrupted]
10. In the past thirty days, how often have you felt
like my home life has been disrupted because of
my HIV status.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
107 [job_adversely_impacte
d]
11. In the past thirty days, how often have you felt
like my business/job has been adversely impacted
because of my HIV status.
radio (Matrix)
1
Never (Kamwe)
2
Sometimes (Wakati mwingine)
3
Often (Mara nyingi)
4
Always (Kila mara)
108 [felt_stigma_questionn
aire_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
109 [worry_of_no_food_in_p
st4wks]
Section Header: First, I would like to ask you some questions to
see if you have experienced any new challenges accessing food
for yourself and your family members. Please answer honestly
and to the best of your knowledge. All responses are
confidential. (Kwanza, ningependa kukuuliza baadhi ya maswali
kuona ikiwa umepitia changamoto yoyote geni ya kujipatia lishe
pamoja na jamii yako. Tafadhali jibu kwa ukweli wako wote na
ufahamu wako. Majibu yote yatakuwa ya siri.)
1. In the past 4 weeks, did you worry that your
household would not have enough food
(Kwa wiki nne zilizopita, je ulikuwa na wasiwasi
kuwa nyumba yako itakosa lishe ya kutosha)
radio
1
Yes (Ndio)
2
No (La)
110 [how_often_do_you_worr
y]
Show the field ONLY if:
[worry_of_no_food_in_p
st4wks] = '1'
1a. How often did this happen
(Jambo hili limefanyika mara ngapi)
dropdown
1
1. Rarely (once or twice in the past 4
weeks) (Nadra (mara moja au mbili
kwa wiki nne zilizopita)
2
2. Sometimes (three to ten times in
the past 4 weeks) (Wakati mwingine
(mara tatu hadi kumi kwa wiki nne
zilizopita)
3
3. Often (more than ten times in the
past 4 weeks (Mara mingi (zaidi ya
Instrument: Household Food Insecurity Access Scale (HFIAS) (household_food_insecurity_access_scale_hfias)

mara kumi kwa wiki nne zilizopita)
111 [didnt_eat_coz_of_no_r
esources]
2. In the past 4 weeks, were you or any household
member not able to eat because of a lack of
resources
(Kwa wiki nne zilizopita , je, wewe ama mtu yeyote
katika jamii yako hamukuweza kupata lishe kwa
sababu ya ukosefu wa pesa)
radio
1
Yes (Ndio)
2
No (La)
112 [how_often_do_you_not_
eat]
Show the field ONLY if:
[didnt_eat_coz_of_no_re
sources] = '1'
2a. How often did this happen
(Jambo hili limefanyika mara ngapi)
dropdown
1
1. Rarely (once or twice in the past 4
weeks) (Nadra (mara moja au mbili
kwa wiki nne zilizopita )
2
2. Sometimes (three to ten times in
the past 4 weeks) (Wakati mwingine
(mara tatu hadi kumi kwa wiki nne
zilizopita)
3
3.Often (more than ten times in the
past 4 weeks) (Mara mingi (zaidi ya
mara kumi kwa wiki nne zilizopita)
113 [eat_smaller_portions_
of_food]
3. In the past 4 weeks, did you or any household
member have to eat smaller portions of food than
you felt you needed because there was not enough
food
(Kwa wiki nne zilizopita, je wewe ama mtu yeyote
katika jamii yako mmelazimika kukula kipimo
kidogo cha chakula kuliko kiwango mnachohitaji
kwa sababu chakula haikutosha)
radio
1
Yes (Ndio)
2
No (La)
114 [how_often_do_eat_smal
ler_portions]
Show the field ONLY if:
[eat_smaller_portions_o
f_food] = '1'
3a. How often did this happen
(Jambo hili limefanyika mara ngapi)
dropdown
1
1. Rarely (once or twice in the past 4
weeks) (Nadra (mara moja au mbili
kwa wiki nne zilizopita )
2
2. Sometimes (three to ten times in
the past 4 weeks) (Wakati mwingine
(mara tatu hadi kumi kwa wiki nne
zilizopita)
3
3.Often (more than ten times in the
past 4 weeks) (Mara mingi (zaidi ya
mara kumi kwa wiki nne zilizopita)
115 [household_food_insecu
rity_access_scale_hfia
s_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
116 [electricity]
Section Header: Before we conclude, I would like to know about
some of the items you have in your household. Which of the
following items does your household own. (Kabla ya kutimisha,
ningependa kujua kuhusu baadhi ya vitu ambavyo unavyo
katika nyumba yako. Je, ni yapi kati ya vitu vifuatavyo ambavyo
nyumba yako inamiliki)
1. Electricity (Umeme)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
117 [radio]
2. Radio (Redio)
radio (Matrix)
Instrument: Household Economic Status (household_economic_status)

1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
118 [television]
3. Television (Runinga/televisheni)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
119 [mobile_phone]
4. Mobile telephone (Simu ya rununu)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
120 [non_mobile_phone]
5. Non-mobile telephone (Simu isiyo ya rununu)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
121 [refrigerator]
6. Refrigerator (Jokofu)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
122 [solar_panel]
7. Solar panel (Jopo la jua)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
123 [table]
8. Table (Meza)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
124 [chair]
9. Chair (Kiti)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)

125 [sofa]
10. Sofa (Kiketi cha sofa)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
126 [bed]
11. Bed (Kitanda)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
127 [cupboard]
12. Cupboard (Kabati)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
128 [clock]
13. Clock (Saa ya ukuta)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
129 [microwave]
14. Microwave oven (Tanuri ya microwave)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
130 [dvd_player]
15. DVD player (Kifaa cha kuchezea DVD)
radio (Matrix)
1
Yes (Ndio)
2
No (No)
98
I don't know (Sijui)
99
Refuse (Kataa)
131 [livestock]
Section Header: 16. How many of each of the following livestock
animals does your household own (Je, ni ngapi ya kila aina ya
mifugo ifuatayo ambayo nyumba yako inamiliki)
a. Cattle (Ngombe)
Number owned
text
132 [sheep]
b. Sheep (Kondoo)
Number owned
text
133 [goat]
c. Goat (Mbuzi)
Number owned
text
134 [chicken]
d. Chicken (Kuku)
Number owned
text
135 [donkey]
e. Donkey (Punda)
Number owned
text

136 [own_other_livestock]
f. Do you own other livestock
yesno
1
Yes
0
No
Custom alignment: RH
137 [other_livestock_name_
1]
Show the field ONLY if:
[own_other_livestock] =
'1'
f. Name of other (1) livestock owned (Jina ya mifugo
mingine)
text
138 [number_of_other_lives
tock_1]
Show the field ONLY if:
[own_other_livestock] =
'1'
g. Number of other (1) livestock owned (Nambari ya
mifugo mengine)
text
139 [other_livestock_name_
2]
Show the field ONLY if:
[own_other_livestock] =
'1'
h. Name of other (2) livestock owned (Jina ya
mifugo mingine)
text
140 [number_of_other_lives
tock_2]
Show the field ONLY if:
[own_other_livestock] =
'1'
i. Number of other (2) livestock owned (Nambari ya
mifugo mengine)
text
141 [other_livestock_name_
3]
Show the field ONLY if:
[own_other_livestock] =
'1'
j. Name of other (3) livestock owned (Jina ya mifugo
mingine)
text
142 [number_of_other_lives
tock_3]
Show the field ONLY if:
[own_other_livestock] =
'1'
k. Number of other (3) livestock owned (Nambari ya
mifugo mengine)
text
143 [use_of_livestock]
17. What are the livestock used for
(Ikiwa jumla ya mifugo inayomilikiwa ni zaidi ya
sufuri
Je, mifugo hii hutumika kwa namna gani)
radio
1
Household consumption (Lishe ya
nyumba)
2
Income generation (Uzalishaji mapato)
3
Both (Zote mbili)
4
N/A (Haihusiki)
144 [own_or_rent_farm_lan
d]
18. Do you rent or own any farm land
(Je unakodisha au unamiliki shamba lolote)
yesno
1
Yes
0
No
Custom alignment: RH
145 [know_acres_owned_by_h
h]
18a. Do you know the number of acres of
agricultural land owned by household
radio

Show the field ONLY if:
[own_or_rent_farm_lan
d] = '1'
(Unajua kiasi ya shamba unayomiliki)
1
Yes
2
No
3
Don't know
Custom alignment: RH
146 [acres_of_land_owned]
Show the field ONLY if:
[know_acres_owned_by
_hh] = '1'
18b. If yes, how many acres of agricultural land
does your household own
(Ikiwa ndio, ni hecta ngapi ya shamba ya kilimo
ambayo nyumba yako inamiliki)
text
147 [use_of_rented_or_owne
d_land]
Show the field ONLY if:
[own_or_rent_farm_lan
d] = '1'
19. What is the land used for
(Je shamba hili latumika kivipi)
checkbox
1
use_of_rented_or_owned_land___1
Rent o
land fo
incom
gener
(Kukod
shamb
ajili ya
kuzali
mapat
2
use_of_rented_or_owned_land___2
Plant c
for
house
consu
(Kupa
mime
ajili ya
ya nyu
3
use_of_rented_or_owned_land___3
Plant c
for inc
gener
(Kupa
mime
ajili ya
kuzali
mapat
4
use_of_rented_or_owned_land___4
Anima
farmin
(Ufuga
wanya
5
use_of_rented_or_owned_land___5
Land i
sitting
(Sham
kutotu
6
use_of_rented_or_owned_land___6
Other
(Nying
148 [other_use_for_land]
Show the field ONLY if:
[use_of_rented_or_own
ed_land(6)]= '1'
19a. If other use for land, specify
text
149 [household_economic_st
atus_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete

1
Unverified
2
Complete
150 [primary_employment]
Section Header: Finally, I would like to ask you about your
current employment and income status. (Kwa kumalizia
ningependa kukuuliza kuhusu hali yako ya sasa ya kuajiriwa na
mapato yako ya sasa hivi.)
1. Which of the following options best describes
your primary employment? You are a
(Je ni gani baadhi ya majibu yafuatayo inaeleza
vyema ajira yako ya msingi? Wewe ni)
Primary employment is defined as the employment
that brings the largest contribution to your
household income.
(Ajira ya msingi ni ajira mayo inachangia pakuu kwa
mapato ya nyumbani kwako)
dropdown
1
1. Farmer (Mkulima)
2
2. Daily laborer/piece work earner in
agricultural or health sector
(Mfanyikazi wa kila siku katika sector
ya ukulima ama afya)
3
3. Wage earner in non-agriculture
large business (factory operation)
(Mfanyi kibarua katika biashara
kubwa isiyo ya kilimo (uendeshaji wa
kiwanda))
4
4. Small business owner (duka, kiosk,
trade in farm produce) (Mfanya
biashara ndogo (Duka, Kiosk, Kuuza
bidhaa ya shamba))
5
5. Artisan (e.g. welder, blacksmith,
craftsman, carpenter) (Juakali (k.v.
fundi wa chuma, seremala, fundi))
6
6. Salaried employee (Mfanyikazi
anayelipwa mshahara)
7
7.Unemployed/not working
(Hujaajiriwa/Hauna kazi)
8
8. Student (Mwanafunzi)
9
9.Retiree (Umestaafu)
10
10.Other (Nyingine)
11
11. Don't know (Sijui)
12
12. Refused to answer (Kataa kujibu)
151 [other_pri_employmen
t]
Show the field ONLY if:
[primary_employment]
= '10'
1a. Please indicate other primary employment not
listed above
(Tafadhali eleza ni ajira ya msingi ipi unayofanya
ambayo haijatajwa hapo awali)
text
152 [est_monthly_income]
Show the field ONLY if:
[primary_employment]
= '1' or [primary_employ
ment] = '2' or [primary_
employment] = '3' or [pr
imary_employment] =
'4' or [primary_employ
ment] = '5' or [primary_
employment] = '6' or [pr
imary_employment] =
'7' or [primary_employ
ment] = '8' or [primary_
employment] = '9'
2. What is your estimated monthly income in
Kenyan shillings (KES)
(Je mapato yako ya kila mwezi ukikadiria katika
fedha za Kenya ni shilling ngapi)
dropdown
1
1. < 1,000
2
2. 1,000 - 2,999
3
3. 3,000 - 4,999
4
4. 5,000 - 9,999
5
5. >10,000
6
6. N/A - receive non-monetary gifts
(Haihusiki- kupokea zawadi ambazo
sio pesa)
98
7. Don't know (Sijui)
99
8. Refused to answer (Kataa kujibu)
Instrument: Employment and Income Status (employment_and_income_status)

153 [time_interview_ended_
arm_c]
Section Header: FOR ARM C PARTICIPANTS ONLY We are now
finished with this survey. Thank you for taking the time to speak
with me today. All of your responses will remain private and the
information you shared will help us during this study. Do you
have any questions? Thank you very much. (Sasa,
tumetamatisha mahojiano haya. Asante kwa kuchukua muda
wako kuzungumza nami leo. Majibu yako yote yatabaki kuwa ya
siri na habari ulizoshiriki zitatusaidia katika utafiti huu. Je,
unayo maswali yoyote? Asante sana.
3. Time interview ended for Arm C
text (time)
154 [employment_and_income
_status_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete
[collapsed]
Instrument: HTN/DM Screening Form (htndm_screening_form)
[collapsed]
Instrument: GISHE Individual Record Form (gishe_individual_record_form)

81 
Appendix IV. Microfinance data collection instruments 

Data Dictionary Codebook
Harambee Survey Assessment Tool (PID: 580)
07/29/2024 9:27pm
#
Variable / Field
Name
Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices, Calculations, etc.)
182 [nature_of_encounter
_visit]
1. Nature of encounter
radio
1
Initial visit
2
Recurrent visit
Custom alignment: RH
183 [gishe_id_number]
Section Header: INDIVIDUAL MEMBER DATA (DATA YA
MWANACHAMA) (to be completed for each individual
member of the group) (Kila mwanachama ajaziwe data
yake)
2. GISHE/Chamaa/MF Group ID Number
(Nambari ya Kikundi)
text
184 [phone_number]
3. Current Phone number
(Nambari ya simu)
text (number, Min: 0)
185 [date_first_join_gro
up]
4. When did this individual first join a
GISHE/Chamaa/MF group
text (date_dmy)
[collapsed]
Instrument: Meta-Data (metadata)
[collapsed]
Instrument: Respondent Demographics (respondent_demographics)
[collapsed]
Instrument: Health Insurance (health_insurance)
[collapsed]
Instrument: OSLO Social Support Scale -3 (oslo_social_support_scale_3)
[collapsed]
Instrument: Adapted Medical Outcomes Study HIV Health Survey (MOS-HIV)
(adapted_medical_outcomes_study_hiv_health_survey_m)
[collapsed]
Instrument: Patient Health Questionnaire-2 (patient_health_questionnaire2)
[collapsed]
Instrument: Adapted ACTG Self Report Adherence
Questionnaire (adapted_actg_self_report_adherence_questionnaire)
[collapsed]
Instrument: Extent of Nonadherence (DOSE-Nonadherence)
Questionnaire (extent_of_nonadherence_dosenonadherence_questionna)
[collapsed]
Instrument: Barriers to Accessing Care (barriers_to_accessing_care)
[collapsed]
Instrument: Patient Satisfaction Survey (patient_satisfaction_survey)
[collapsed]
Instrument: Felt Stigma Questionnaire (felt_stigma_questionnaire)
[collapsed]
Instrument: Household Food Insecurity Access Scale (HFIAS)
(household_food_insecurity_access_scale_hfias)
[collapsed]
Instrument: Household Economic Status (household_economic_status)
[collapsed]
Instrument: Employment and Income Status (employment_and_income_status)
[collapsed]
Instrument: HTN/DM Screening Form (htndm_screening_form)
Instrument: GISHE Individual Record Form (gishe_individual_record_form)

Show the field ONLY i
f:
[nature_of_encounter_
visit] = '1'
(Je, mara ya kwanza mwanakikundi huyu
kujiunga na kikundi ilikuwa lini)
186 [total_share_contrib
uted]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '1'
5. Total amount of shares contributed in this
current GISHE/Chamaa/MF group
(Jumla ya hisa (pesa) alizochanga katika kikundi
hiki cha sasa)
text (integer, Min: 0, Max: 100000)
187 [outstanding_loan_ba
l]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '1'
6. Total outstanding loan balance in this current
GISHE/Chamaa/MF group
(Jumla ya pesa za mkopo alizonazo katika
kikundi hiki cha sasa)
text (integer, Min: 0, Max: 100000)
188 [no_of_meetings_atte
nded]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2'
Section Header: RECCURENT DATA
7. Number of meetings attended during last
period
(Nambari ya mikutano uliyohudhuria kwa
musimu uliopita)
text (number, Min: 0, Max: 60)
189 [total_shares_purcha
sed]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2'
8. Total number of shares purchased during the
last period
(Jumla ya hisa zilizonunuliwa msimu uliopita)
text (integer, Min: 0, Max: 100000)
190 [loans_disbursed]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2'
9. Total amount of loans disbursed during the
last period
(Jumla ya mikopo iliyochukuliwa msimu uliopita)
text (integer, Min: 0, Max: 100000)
191 [loan_bal_outstandin
g]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2'
10. Total loan balance outstanding on current
date
(Jumla ya mikopo ambazo hazijalipwa hadi sasa)
text (integer, Min: 0, Max: 100000)
192 [purpose_for_loan]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2' and [loans_d
isbursed] <> ''
11. For what purpose did this member use the
borrowed funds during the last period
(Je, mwanachama alitumia pesa alizokopa
msimu uliopita kufanya nini)
checkbox
1
purpose_for_loan___1
To pay off
other debts
2
purpose_for_loan___2
To buy farm
inputs such
as seeds, ox
plough
3
purpose_for_loan___3
To pay
school fees

for children
4
purpose_for_loan___4
To pay for
medical
expenses
(health
insurance,
medical
fees,
medications)
5
purpose_for_loan___5
To trade and
invest in
small
business
6
purpose_for_loan___6
To repair
shelter or
homestead
7
purpose_for_loan___7
To buy
clothing for
self and
family
8
purpose_for_loan___8
Other
193 [other_use_of_loan]
Show the field ONLY i
f:
[purpose_for_loan(8)]
='1'
11a. If other use of loan specify
text
194 [use_social_fund]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2'
12. Did this individual use the social fund during
this period
(Je, mwanachama alitumia pesa za mfuko wa
jamii katika msimu uliopita)
radio
1
Yes- Granted, no payment
2
Yes- Borrowed with repayment
3
No
Custom alignment: RH
195 [funds_repaid_during
_period]
Show the field ONLY i
f:
[use_social_fund] = '2'
12a. If yes, borrowed with repayment, were the
funds repaid during this period
(Kama ni ndio-kuomba na malipo, je pesa
zililipwa kwa msimu huo)
yesno
1
Yes
0
No
Custom alignment: RH
196 [social_fund_without
_repayment]
Show the field ONLY i
f:
[use_social_fund] = '1'
12b. If yes- granted with no repayment, what
was the reason for using the social fund
(Kama ni ndio, je pesa za mfuko wa jamii
zilitumika kufanya nini)
dropdown
1
1.Bereavement/Funeral
2
2. Hospital/Medical fees
3
3. School fees
4
4. Celebration (birthday, baby
shower)
5
5. Natural disaster (drought, flood,
fire)

6
6. Other
197 [other_reason_for_so
cial_fund]
Show the field ONLY i
f:
[social_fund_without_r
epayment] = '6'
12c. If other reason, specify
(Kama ni nyingine, taja)
text
198 [defaulted_since_las
t_encounter]
Show the field ONLY i
f:
[nature_of_encounter_
visit] = '2'
13. Has this individual defaulted during the last
encounter
(Je mwanachama huyu amakosa kulipa mkopo
wake tangu mara ya mwisho mlipokutana)
yesno
1
Yes
0
No
Custom alignment: RH
199 [reasons_defaulted]
Show the field ONLY i
f:
[defaulted_since_last_
encounter] = '1'
13a. If defaulter, give reasons for defaulting
(Kama ni ndio, je ni jambo lipi lilimsababisha
kutolipa mkopo)
checkbox
1
reasons_defaulted___1
No longer
attending
meetings
2
reasons_defaulted___2
No longer able
to
contribute/sha
3
reasons_defaulted___3
Emergency
(Family, health,
death)
4
reasons_defaulted___4
Defaulted on
loan
5
reasons_defaulted___5
Other
200 [other_reason_defaul
ted]
Show the field ONLY i
f:
[reasons_defaulted(5)]
= '1'
13b. If other reason for defaulted, specify
(Kama ni nyingine, taja)
text
Custom alignment: RH
201 [time_interview_ende
d]
Section Header: We are now finished with this survey.
Thank you for taking the time to speak with me today. All of
your responses will remain private and the information you
shared will help us during this study. Do you have any
questions? Thank you very much. (Sasa, tumetamatisha
mahojiano haya. Asante kwa kuchukua muda wako
kuzungumza nami leo. Majibu yako yote yatabaki kuwa ya
siri na habari ulizoshiriki zitatusaidia katika utafiti huu. Je,
unayo maswali yoyote? Asante sana.
14. Time interviewed ended
(Wakati mahojiano yalikamilika)
text (time)
202 [gishe_individual_re
cord_form_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete

Instruments
Events
Data Dictionary Codebook
GISHE Group Record Form (PID: 575)
07/29/2024 9:31pm
#
Variable / Field
Name
Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices, Calculations,
etc.)
1
[harambee_study_gro
up_id]
1.Harambee study group ID
(Nambari ya utambulisho wa Kikundi)
text
2
[collection_date]
2. Date of data collection
(Tarehe ya kukusanya ujumbe)
text (date_dmy), Required
3
[study_county]
3. County of study
radio
1
Busia
2
Trans Nzoia
Custom alignment: RH
4
[mf_group_name_in_b
usia]
Show the field ONLY
if:
[study_county] ='1'
4. Microfinance group name in Busia county
dropdown
1
Jipe Moyo Support Group
2
Wapendanao Support Group
3
Sisi Pekee Yetu (Hatuko Pekee
Yetu)
4
Safina Support Group
5
Mabinju Support Group
6
Tujitolee Support Group
7
Heri Mimi Support Group
8
Magombe Abakanya Support
Group
9
Abemanya Afya Support Group
10
Mundika Support Group
11
Mubwayo Support Group
12
Faith Support Group
13
Survivor 2
14
Habari Njema Support Group
15
Survivor 3 Support Group
16
Roho Moja ni Moja Support
Group
17
Njia Moja Kazi Moja Support
Group
Instrument: GISHE Group Record Form (gishe_group_record_form)

18
Tumaini Support Group
19
Bukalama Support Group
20
Alakara Support Group
21
Amua Support Group
22
Amerikwai Post-Test Support
Group
23
Amua Support Group
Mukhobola
24
Kakurikit Esenyi Support Group
25
Kisandu Support Group
26
Murende Support Group
27
Lwanya Support Group
28
Munongo Werusia Support
Group
29
Afya ni Bora Support Group
30
Linda Maisha Support Group
31
Amuka Ujitegemee Support
Group
32
Mudoma Support Group
33
Abakhaywa Support Group
34
Tumaini Budwong'i Support
Group
35
Ageng'a Star Support Group
36
Esiri Muefwe Siri Mueng'we
Support Group
37
Tumekubali Support Group
38
Motomoto Support Group
39
Muramba Support Group
40
Other
5
[other_group_name_b
usia]
Show the field ONLY
if:
[mf_group_name_in_
busia] = '40'
4.1. Other group name in Busia County
text
6
[study_group_name_i
n_tn]
Show the field ONLY
if:
[study_county] = '2'
4a. Microfinance group name, in Trans Nzoia
county
dropdown
1
Amua Support Group
2
Busiere Support Group
3
Faith Support Group

4
Healing Support Group
5
Imahutu Support Group
6
Ingakha Support Group
7
Jihimize Support Group
8
Jipange Support Group
9
Jitahidi Support Group
10
Lungai Support Group
11
Maandalio Support Group
12
Maisha Bora Support Group
13
Misege Support Group
14
Mkuyuni Support Group
15
Msamaria Support Group
16
Neema Support Group
17
Rays Of Hope Support Group
18
Sango Support Group
19
Umoja Support Group
20
Other
7
[other_group_name_t
nz]
Show the field ONLY
if:
[study_group_name_i
n_tn] = '20'
4a.1. Other group name in Trans Nzoia County
text
8
[nature_of_encounte
r]
5. Nature of encounter
radio
1
Initial visit
2
Recurrent visit
Custom alignment: RH
9
[name_of_info_provi
der]
Show the field ONLY
if:
[nature_of_encounte
r] = '1'
6. Name of person providing information
(Jina la mtu anayepeana ujumbe)
text, Required
10
[role_of_info_provi
der]
Show the field ONLY
if:
[nature_of_encounte
r] = '1'
7. Role of person providing information
(Jukumu la mtu anayepeana ujumbe)
radio
1
Secretary/Record Keeper
(Katibu/Mlinda rekodi)
2
Treasurer/Box Keeper (Mweka
hazina/Mlinda kisanduku)
3
Chairperson (Mwenyekiti)

4
Money Counter (Mhesabu Hela)
6
Vice Chair (Naibu wa Mwenyekiti)
5
Other (Nyingine)
11
[other_role]
Show the field ONLY
if:
[role_of_info_provide
r] = '5'
7a. If other role, specify:
(Kama ni nyingine, bainisha):
text
12
[current_cycle_numb
er]
Show the field ONLY
if:
[nature_of_encounte
r] = '1' or [nature_of_
encounter] = '2'
8. What is the current cycle number of the
group
(Je. kikundi hiki imegawa pesa mara ngapi
tangu ianza)
text (number, Min: 0, Max: 14)
13
[current_cycle_star
t_date]
Show the field ONLY
if:
[nature_of_encounte
r] = '1' or [nature_of_
encounter] = '2'
9. When did the current cycle start
(Je, huu mzunguko wa sasa ulianza lini)
text (date_dmy), Required
14
[total_group_no_cyc
_start]
Show the field ONLY
if:
[nature_of_encounte
r] = '1' or [nature_of_
encounter] = '2'
10. Total number of members in the group at
the start of this current cycle
(Nambari ya wanachama katika kikundi hiki
mwanzo wa mzunguko huu wa sasa)
text (integer, Max: 40)
15
[group_active_tota
l]
Show the field ONLY
if:
[nature_of_encounte
r] = '1' or [nature_of_
encounter] = '2'
11. Total number of active group members in
this current cycle
(Nambari ya wanachama wanao shiriki
kikamilifu katika mzunguko wa sasa)
(Note: active members are regularly attending
GISHE meetings and pay shares/social funds)
(Kumbuka: Wanachama wanao shiriki
kikamilifu ni wale ambao huhudhuria
mikutano ya Chamaa mara kwa mara na
hulipa fedha za hisa/kusaidia katika janga)
text (integer, Max: 40)
16
[date_of_last_encou
nter]
Show the field ONLY
if:
[nature_of_encounte
r] = '2'
Section Header: The following questions refer to the data
collection period starting from the last encounter when
the form was collected to the present. (Maswali yafuatayo
yanahusiana na wakati wa ukusanyaji wa ujumbe (deta)
kuanzia mara ya mwishofomu ilipojazwa hadi sasa)
12. Date of last encounter when form was
collected
(Tarehe ambayo fomu ilijazwa mara ya
mwisho)
text (date_mdy)

17
[number_of_meeting
s]
Show the field ONLY
if:
[nature_of_encounte
r] = '2'
13. How many meetings took place during the
data collection period
(Je, ni mikutano mingapi zilifanywa wakati wa
ukusanyaji wa ujumbe)
text (number, Min: 0, Max: 15)
18
[meet_as_a_group]
Show the field ONLY
if:
[nature_of_encounte
r] = '1'
Section Header: GROUP PROCESS (Mchakato wa kikundi)
14. How often do you meet as a group
(Je, huwa munakutanamara ngapi lama
kikundi)
radio
1
Weekly (Kila Wiki)
2
Bi-monthly (Baada ya wiki mbili)
3
Monthly (Kila Mwezi)
4
Quarterly (Baada ya miezi tatu)
5
Other (Nyingine)
19
[meet_as_a_group_sp
ecify]
Show the field ONLY
if:
[meet_as_a_group] =
'5'
14a. How often do you meet as a group, other
specify:
(Je, huwa munakutanamara ngapi lama
kikundi, nyingine, bainisha):
text
20
[registration_fee]
Show the field ONLY
if:
[nature_of_encounte
r] = '1'
13. Registration fee amount
(Fedha ya kujiandikisha katika kikundi)
text (integer, Min: 0, Max: 20000)
21
[social_fund_value]
Show the field ONLY
if:
[nature_of_encounte
r] = '1'
14. Single social fund value
(Fedha ya kusaidia katika janga)
text (integer, Min: 0, Max: 20000)
22
[single_share_valu
e]
Show the field ONLY
if:
[nature_of_encounte
r] = '1'
15. Single share value
(Thamani ya hisa moja)
text (integer, Min: 0, Max: 20000)
23
[gishe_group_record
_form_complete]
Section Header: Form Status
Complete?
dropdown
0
Incomplete
1
Unverified
2
Complete

91 
Appendix V: Adult Consent Form 3  
(For microfinance group members or AMPATH staff who are asked to participate in Aim 2 in-
depth interviews)  
Title of Research: 
Harambee: Integrated Community-Based HIV/NCD Care and 
Microfinance Groups in Kenya 
Principal Investigators: 
Juddy Wachira; Becky Genberg; Omar Galarraga 
IREC Approval #:  
0003054 
Sponsor: 
National Institute of Mental Health (NIMH) 
Version Date: 
23 February 2021 
What you should know about this study 
•
You are being asked to join a research study.
•
This consent form explains the research study and your part in the study.
•
Please read it carefully and take as much time as you need.
•
You are a volunteer. You may choose not to take part in the study at all. If you choose to join
the study, you may quit at any time. There will be no penalty if you decide to quit the study.
•
During the study, we will tell you right away if we learn any new information that might
affect whether you wish to continue to be in the study.
What is the purpose of research study? 
The purpose of this research study is to learn if offering HIV care and other health services in the 
community, instead of at a health facility, will help people who are living with HIV to live healthier lives. 
This research study also wants to learn if offering HIV care and other health services to people who are 
members of microfinance groups will help people who are living with HIV to live healthier lives.  
What will happen if you agree to participate in the study? 
If you agree to participate in this study, you will be interviewed by a trained member of our research 
team. This interview will last approximately one hour and will take place in a private, quiet, and 
convenient location, off-site of AMPATH. The interview will include a discussion of factors that you 
believe are important to understand integration of HIV and primary care into microfinance groups. If you 
agree to participate, the interviewer will record the interview using a digital recording device. The 
interviewer may also take notes during the interview. 
What type of questions will be asked during the interview? 
The purpose of the interview is to learn how microfinance groups help patients with HIV live healthier 
lives. The purpose of the interview is also to learn how delivering HIV care in the community help 
patients with HIV live healthier lives. 
Risks of taking part in this study 

92 
There are no physical risks associated with participating in this study. You may experience psychological 
discomfort when sensitive topics are discussed. There is a minimal risk of losing confidentiality (privacy). 
However, the research staff will be sure that your records are kept safe and your personal information is 
not given to anybody without permission. All of the information you provide and all of your responses 
during the interview will be coded with a study ID and will never include your name. 
Benefits of taking part in the study 
We do not know if HIV care in the community keeps HIV-infected people as healthy as HIV-infected 
people who receive care at a health facility. It is possible that you may receive no benefit from being in 
this study. Information learned from this study may help others who are infected with HIV live healthier 
lives.  
Confidentiality 
Your name or other information that may identify you will not be associated with your answers during 
this interview, the recording, transcription, or any other notes made by the interviewer. We will transcribe 
the interview from the recording and destroy the audio file. The transcribed documents will be stored in 
secure locations and digital files will be protected with passwords. Only members of the study team will 
have access to the data. No one at AMPATH, including your physician, AMPATH employees, or other 
patients, will know your answers to the questions in this interview. 
We will try very hard to keep your information confidential (private). We cannot guarantee absolute 
confidentiality. Your information could be shared if required by the law. A group of people may look at 
our research records to make sure they are complete and true. A group may also look at our records for 
data analysis (to see what the information people shared with us means). The groups looking at the 
records could be study investigators and their research partners, the Moi Institutional Research and Ethics 
Committee (IREC), the Indiana University Institutional Review Board (IRB), the Brown University 
Institutional Review Board (IRB), the Purdue University Institutional Review Board (IRB), the Johns 
Hopkins University Institutional Review Board (IRB), the study staff, or the sponsor (NIH). 
Data Sharing 
We will not share the data from this study with anyone outside of our study staff team. 
Costs 
There will be no cost to you to participate in this interview.  
Payment/Compensation 
If you choose to participate in an interview, you will receive KES 300 as a thank you for your time. You 
will also receive refreshments during the interview.  
What will happen if you miss or cannot attend your scheduled interview? 
If you do not attend your scheduled interview for any reason, the study staff will contact you to schedule a 
follow-up interview.   
Who is sponsoring this study? 

93 
This research is funded by the National Institutes of Health in the United States. This means that the 
research team is being paid by the sponsor for doing the study. The researchers do not, however, have a 
direct financial interest with the sponsor or in the final results of the study.  
Your alternatives to joining the study 
Your participation in this study is voluntary. You may refuse to participate and there will be no penalty for 
refusing. Refusing to participate will not impact any care you receive from AMPATH, or any other 
provider. You may choose to discontinue your participation at any time without penalty.  
Ending Consent 
You may end your consent at any time. Information obtained and used before you end your consent will 
continue to be used for research. If you wish to end your consent, please let us know.  
Who do you call if you have questions or problems related to the study? 
•
Call the principal investigator: Juddy Wachira at 070-524- 2450
•
Call or contact the Moi University Institutional Research and Ethics Committee (IREC) if you
have questions about your rights as a study participant. Contact IREC if you feel you have not been
treated fairly or if you have other concerns. The IREC contact information is:
Address: 
Moi Teaching and Referral Hospital  
Institutional Research and Ethics Committee  
2nd floor. Door No. 219, 
P.O. Box. 3-30100  
Eldoret, Kenya 
Office line: 0787723677 
Email: irecmtrh@gmail.com or contact@irec.or.ke 
What does your signature on this consent form mean? 
Your signature on this form means: 
•
You have been informed about this study’s purpose, procedures, possible benefits and risks.
•
You have been given the chance to ask questions before you sign.
•
You have voluntarily agreed to be in this study.
___________________________  _____________________________     __________ 
Print name of Adult Participant       Signature of Adult Participant                 Date 
___________________________  _____________________________     __________ 
Print name of Person Obtaining Consent   Signature of Person Obtaining Consent   Date   

94 
Appendix VI: KEY INFORMANT INTERVIEW GUIDE – PARTICIPANTS 
Introduction: Review the study procedures and details with participant, including audio recording, 
confidentiality, and rights to refuse participation. Obtain informed consent. 
Because you are a patient of an AMPATH clinic, we want to learn about your experience receiving HIV 
and primary care through AMPATH. (If the participant is also in a microfinance group, you can also say 
that you want to learn about their experience as a microfinance group member.) We also want to hear 
about some of the challenges you face in getting care and about what would help you to receive the care 
your need on a regular basis.   
Please remember that anything you say during this interview will be not be shared with anyone at 
AMPATH or in the community.    
I. Socio-demographic:
a)
Age in years
a)
Gender
b)
Most recent visit to AMPATH clinic and reason for visit
c)
Time has been a member of a microfinance group (for trial participants)
II. ART adherence barriers and facilitators
The intent of this portion of the agenda is to explore participant’s self-reported barriers/facilitators to 
accessing HIV care, including household economic conditions, food security, geography/distance, social 
support, and HIV-related stigma.  
1.
Lead question: What was your biggest concern when you found out you were HIV positive and
started ART?
2.
Follow-up question: Do you take your ART medication as indicated? What are some reasons why
you do not or have not taken your ART medication as indicated, meaning as often or as much as
told by medical personnel?
3.
Follow-up question: When you WANT to stay adherent ART, what gets in the way?
a.
Medication/regimen: How does the medication experience (side effects, schedule,
dosing) affect your ability to take ART as prescribed?
b.
Patient factors:
i.
Probe: developmental hallmarks such as family responsibility
ii.
Probe: specific challenges relating to mental health
c.
Peer, partner, family factors
i.
Probe: Support (or lack of support) from family, friends, clinicians, others
ii.
Probe: Does HIV stigma affect your decision to take ART? How? (explore covert
ART use and concerns over inadvertent disclosure)
d.
Clinician factors
i.
Probe: positive and negative provider attitudes for clinical needs of people living
with HIV
ii.
Probe: differences (if any) in experience between clinical care environments (e.g.,
different clinics, different regions)
e.
Structural factors: What about living in your community makes it easy or hard for you to
take ART as prescribed?
i.
Probe: Transport, food security, housing, migration

95 
f.
Lead question: What helps you to STAY adherent to ART? “Adherent” means taking
medication as often and/or as much as told by medical personnel.
III. Acceptability of receiving NCD/HIV integrated care in the community via microfinance groups
The intent of this portion is to introduce the idea of delivering NCD/HIV integrated care in the community 
via microfinance groups and to explore the acceptability ICB as a strategy for supporting better ART 
adherence in people living with HIV.  
1.
Lead question: We want to understand what you think about using microfinance groups to help
people improve adherence to ART. By adherence we mean taking ART as prescribed. Do you think
you and other people who are living with HIV would like to receive NCD/HIV care in the community
when they attend a microfinance group meeting?
2.
Lead: Can you tell us about how to design this type of health care service so that it supports
adherence to ART among people who are living with HIV?
a.
How should the NCD/HIV care be DELIVERED to people in the community (e.g., to
individuals privately, to a group of people trying to adhere)?
b.
How OFTEN should NCD/HIV service be delivered in the community (e.g., at every
microfinance group meeting, at the payout meetings, monthly, quarterly?)
3.
Follow-up question: To make sure you and other people who are living with HIV have all the support
they need to adhere to ART, should NCD/HIV care be delivered on its own or in combination with
other programs (such as motivational support, education on why adherence is important and how to
adhere, or group/peer support groups for adherence)?
Closing: Thank participant for their time. Remind participant about the confidentiality of the interview. 
Ask if they have any questions about anything that was discussed.  
EXAMPLE: Thank you for your time and for sharing your thoughts with us. We want to remind you that 
your comments will remain confidential. Do you have additional questions or comments? 

96 
Appendix VII: KEY INFORMANT INTERVIEW GUIDE – PROVIDERS 
Introduction: Review the study procedures and details with participant, including audio recording, 
confidentiality, and rights to refuse participation. Obtain informed assent/consent. 
AMPATH oversees over 1,300 microfinance groups, with 48 of these groups composed of only members 
living with HIV. AMPATH has begun to deliver chronic disease care, mainly for hypertension and 
diabetes, in a community-based group setting to those participating in microfinance groups. Our aim is to 
investigate whether it is feasible to adapt this model of group-based care delivery to address the needs of 
people living with HIV in microfinance groups.  
We want to gather your thoughts on community-based care models, the strengths and challenges of 
integrating care, and the considerations that must be made when delivering HIV care outside of the 
health facility. We are particularly interested in your experience delivery NCD/HIV care to via 
microfinance groups through your role as a (insert job title).  
A. Socio-demographic:
a)
Age in years
a)
Gender
b) Health provider cadre
c)
Length of time working at AMPATH
B. Warm-up:
1.
Tell me about yourself and your role within the AMPATH program
Probes: Can you describe a normal working day for you?
Perception about patient involvement in community-based groups 
2.
What is your perception about community-based groups?
Probes:
•
Perception about social support groups?
•
Perception about microfinance groups? E.g chamaz, merry-go-rounds
3.
Do you know of any patient(s) in your clinic in any kind of community-based financial group(s)?
If NO move to next question
If YES continue with probes
Probes:
•
Provide a small description about the group(s)
•
What is the role of the group(s)?
•
How are patients in these groups different from patients who are not in any group?
4.
What do you think about patient’s participation in community-based financial group(s) (including
GISE, chama cha mama toto, joywo)?
Probes:
•
What are the advantages of patients participating in community-based financial
groups? (explore positive aspects on social, economic and health outcomes)
•
What are the disadvantages of patients participating in community-based financial
groups? (explore negative aspects on social, economic and health outcomes)
Perception about care delivery beyond the health facility 

97 
5.
What is your perception about delivering care to patient(s) outside the health facility?
Probes:
•
What kind of care would you deliver?
•
For what kind of diseases?
•
How would you deliver this care?
•
Where would you prefer to deliver this care?
•
What are the advantages of delivering care to patients outside the health facility?
•
What are the disadvantages of delivering care to patients outside the health facility?
Integrating HIV care into community-based groups 
6.
What do you think about the idea of delivering HIV care to microfinance groups in the
community as opposed to providing care at the health facility?
Probes:
•
Why do you feel this way?
7.
What do you think are the advantages of delivering HIV care to microfinance groups at the
community level as opposed to providing care at the health facility?
Probes:
•
Advantages to the patient (patient health outcomes, efficiency of care, quality of
care)
•
Advantages to the provider at the facility level (efficiency of delivery, quality of
care)
•
Advantages to the provider at the community level (efficiency of delivery, quality of
care)
8.
What do you think are some the challenges with delivering HIV care to microfinance groups at
the community level as opposed to offering care at the health facility?
Probes:
•
Challenges to the patient (patient health outcomes, efficiency of care, quality of care)
•
Challenges to the provider at the facility level (efficiency of delivery, quality of care)
•
Challenges to the provider at the community level (efficiency of delivery, quality of
care)
9.
How is delivering HIV care in microfinance groups different from providing care for other
chronic diseases?
10. What do you think would make delivering HIV care to microfinance groups successful at the
community level?
Probes:
•
What kind of services should be delivered?
•
Who should deliver the services within the groups?
•
What would be the qualification of the providers who deliver care at the
community level? (academic and personality traits, relationship to community)
•
What would be the composition of microfinance care groups? (Gender, Number,
Disease/Health status)

98 
•
How often would the patients need to be seen at the facility?
•
What could be done to ensure patient data collected at the community is captured
by the AMPATH program?
•
What could be done to make delivering HIV care to microfinance groups
sustainable?
Perceived patient perspective 
11. What concerns do you think patients may have about integrating HIV care into microfinance
groups?
Probes:
•
What do you think they may like about this integrated care model?
•
What do you think they may dislike about this integrated care model?
Additional comments 
12. Is there anything else that is important for me to understand about community-based care delivery
from your perspective? How about microfinance groups? How about the integration of HIV care
into microfinance groups?
Closing: Thank participant for their time. Remind participant about the confidentiality of the interview. 
Ask if they have any questions about anything that was discussed.  
EXAMPLE: Thank you for your time and for sharing your thoughts with us. We want to remind you that 
your comments will remain confidential. Do you have additional questions or comments? 

99 
Appendix VIII: NCD screening protocol at study baseline (implemented in all microfinance groups (Study Arms A and B)) 
Hypertension (HTN) 
Diabetes (DM) 
Screening 
(study baseline) 
Screening 
(confirmatory  
after 1 month) 
1-month confirmatory screening not required 
SBP: systolic blood pressure; DBP: diastolic blood pressure; FBS: fasting blood sugar; RBS: random blood sugar; HbA1C: hemoglobin A1C. 
Screening for hypertension and diabetes was conducted in the community for all microfinance group members randomized to standard, facility-
based (usual) care and to microfinance group members randomized to the integrated, community-based care intervention.
Screen for HTN in community groups1 
SBP > 140mmHg or 
DBP > 90mmHg 
Patient needs confirmatory 
screening in 1 month 
Screen for DM in community groups
SBP < 140mmHg 
and DBP < 90mmHg 
Discharge 
FBS > 6.1 mmol/L or 
RBS > 7.8 mmol/L 
FBS < 6.0 mmol/L and 
RBS < 7.7 mmol/L 
Perform HbA1C NOW test 
HbA1C < 6.5 mmol/mol 
HbA1C > 6.5mmol/mol 
Counsel on primary prevention; 
Discharge 
Patient has confirmed DM, 
begin or continue treatment 
Confirmatory screening for HTN in community group 
SBP > 140mmHg or 
DBP > 90mmHg 
SBP < 140mmHg 
and DBP < 90mmHg 
Patient has confirmed HTN; begin or 
continue treatment  
Discharge 

100 
Addendum to the overall project protocol 
This addendum summarizes changes that were made to the overall project protocol after the start 
of Aim 1 data collection on November 25, 2020.  
1.
The eligibility criteria in the original project protocol required that a group had to be an active,
AMPATH-affiliated Group Integrated Savings for Health Empowerment (GISHE) group in order to
enroll in the study. This criterion was revised during the recruitment period such that any active,
community-based microfinance group (GISHE and non-GISHE) were eligible to enroll in the trial as
long as a majority of their members received HIV-related care at an AMPATH facility. This change
was made to maximize sample size given that many GISHE groups had transitioned to community
ART groups at the time of study recruitment.
2.
The original protocol stated that, among microfinance groups randomized to the intervention arm,
integrated community-based care visits would occur monthly during months 1-6 of the trial and then
quarterly for the remaining months (i.e., months 7-18 of the trial).
Starting in October of 2021, integrated care visits were no longer delivered monthly during months 1-
6 of the trial, and instead were delivered less frequently during months 1-6. Specifically, microfinance
group enrollment and follow-up occurred in four phases, such that:
•
Phase I intervention groups in Busia and Trans Nzoia County received monthly visits during
months 1-6 of the trial, and quarterly visits thereafter (in accordance with the original
protocol).
•
Phase II intervention groups in Trans Nzoia County received monthly visits during months 1-
6 of the trial, and quarterly visits thereafter.
•
Phase II, Phase III and Phase IV intervention groups in Busia County received monthly visits
during the first three study visits (i.e., months 0 - 2 of the trial), and quarterly visits thereafter
(i.e., from months 3 – 18).
This change to the intervention delivery schedule was made to reduce administrative burden on 
clinical officers and study staff traveling to remote community meeting locations. Quarterly (rather 
than monthly) visits were still in keeping with AMPATH care protocols which most commonly 
recommend quarterly ART distribution for clinically stable HIV patients. 
3.
The original project protocol stated that integrated community-based care would be delivered to
intervention groups at monthly microfinance group meetings by a clinical team comprised of the
same cadre of workers who deliver care in AMPATH-supported facilities (clinical officer, pharmacy
technician, peer navigator, social worker).
The protocol was revised after the start of enrollment (in November 2020) and prior to the start of the
first integrated care visit in the community (in May 2021) such that solely a clinical officer attended
each integrated care visit. This change was made to minimize the amount of attention drawn to
intervention recipients during study visits in the community (e.g., to help minimize the potential for
HIV-related stigma), to have community-care visits more closely mimic the personnel present during
facility-based HIV visits, and to minimize administrative costs. The change was also made based on
recommendations from AMPATH leadership and Ministry of Health personnel working in the
respective study counties; these personnel suggested having minimal care personnel travel to the
community as a way to minimize administrative costs and increase the likelihood the established HIV
care and CDM programs would be able to take over the intervention model after study completion.

101 
The clinical officer who delivered community-based care worked closely with facility-based 
personnel, including a pharmaceutical technician (helped with packaging of drugs), retention worker 
(assisted with tracking down lost-to-care participants), other facility-based clinical officers (received 
participants who were referred back to facility for emergencies, released participants who were 
eligible for community-based care), health records officers (facilitated access to patients records for 
data entry and/or retrieval as needed). For all microfinance groups, a phlebotomist attended the 18-
month study visit in the community to collect blood samples to assess the study’s primary outcome.  
4.
The original project protocol assumed that attending routinely scheduled microfinance group
meetings would serve as a sufficient, built-in incentive for remaining engaged in the study and
attending study visits. However, the study received Moi University Institutional Research and Ethics
Committee (IREC) approval on April 20, 2021 to provide an inconvenience fee of 300 KES (~$2.5)
for each survey assessment that enrolled study participants completed during the randomized trial.
The study received IREC approval on April 20, 2021 to provide an inconvenience fee of 300 KES as
well as lunch/refreshments to study participants and key stakeholders who participated in the Aim 2
in-depth interviews. The provision of inconvenience fees aimed to maximize retention and increase
equity in human subjects research.
5.
The original project protocol stated that the primary endpoint was achievement of HIV viral
suppression (HIV-RNA <400 copies/mL) at 18 months. The definition of the primary endpoint was
changed such that patients whose 18-month viral load assessment was before January 1, 2023 were
considered virologically suppressed if their viral load was <400 copies/mL, and patients whose 18-
month viral load assessment was on or after January 1, 2023 were considered suppressed if their viral
load was <200 copies/mL. This change to the primary endpoint definition was made to reflect
changes to Kenya’s national recommendations for HIV monitoring cutoffs that took effect in August
2022 during the active follow-up period.
6.
The original project protocol stated that blood draws for viral load assessments (primary outcome)
would be ascertained for all participants during their 18-month study visit. This protocol was revised
such that if a participant had a viral load result available in their medical records within the 3 months
prior to their 18-month assessment date, then this result was used to assess their 18-month viral load.
This change was made to reduce burden on participants by preventing them from having to provide
multiple blood samples within less than 6 months of one another, and to conserve administrative
resources and phlebotomist effort.
7.
The original project protocol stated that the secondary endpoints of (1) absolute mean change in
systolic blood pressure and (2) absolute mean change in HbA1c level from 0 to 18 months would be
assessed among all enrolled trial participants. This was revised such that the secondary endpoints of
(1) absolute mean change in systolic blood pressure and (2) absolute mean change in HbA1c level
were only assessed among members of randomized microfinance groups, and were not assessed
among matched standard of care patients. This change was made primarily to reduce administrative
and logistical burden on the research team. After beginning the matching process, many of the
eligible, matched standard of care patients were patients of health facilities that were distinct from
those where the majority of microfinance group members received care. For several matched patients,
they were the only Harambee participant who was a patient of that health facility. Thus, the human

102 
and capital (e.g., fuel) resources needed to travel to the distinct health facilities to ascertain secondary 
outcome data for each matched patient were prohibitively high.  
8.
In order to enroll 300 patients receiving standard facility-based care and not engaged in a
microfinance group (SOC), the original protocol stated that enrolled microfinance group participants
should be matched 3:1 to eligible SOC patients on county, gender, age (+/- 5 years), and health
facility. The matching protocol was revised on February 8, 2022 such enrolled microfinance group
participants were matched 3:1 to eligible SOC patients on gender and age (+/- 5 years of microfinance
participant). This change was made because most SOC patients who were invited to enroll in Busia
County after February 8, 2022 were ineligible for study participation due to membership in either a
microfinance group or a community ART Group. This change resulted in approximately 90 enrolled
microfinance group members in Busia County being matched to 30 SOC patients in Trans Nzoia
County on (1) age (within +/- 5 years of the GISHE participant’s age) and (2) gender.
9.
The original project protocol stated that group randomization would occur using a computer-
generated sequence to randomize microfinance groups to receive either integrated community-based
care (ICB) or standard of care, and that the randomization process would be conducted centrally by
biostatisticians at Brown University.
The cluster randomization approach was revised to use a transparent, community-engaged approach
to increase transparency and cultivate trust between research personnel and study participants, clinical
personnel, and local community leaders. Below is a summary of the steps that were implemented for
at each community-engaged randomization ceremony. Six randomization ceremonies were conducted
among the 57 microfinance groups following enrollment:
•
2 randomization ceremonies each with 10 microfinance groups were conducted in Phase I
groups
•
2 randomization ceremonies each with 11 and 8 microfinance groups were conducted in
Phase II groups
•
1 randomization ceremony with 15 microfinance groups was conducted in Phase III groups
•
1 randomization ceremony with 3 microfinance groups was conducted in Phase IV groups
The below steps describe the community-engaged randomization process. 
Participants  
1.
Group leaders (Chairperson, Secretary & Treasurer)
2.
AMPATHPlus Senior Technical Officers (STO)
3.
AMPATHPlus Program Officers (PO) (Sub-counties represented)
4.
Facility-in-Charge (Respective health facilities)
5.
(S)CASCOs (MoH county and sub counties represented)
6.
Retention Officers (Respective Health Facilities)
7.
Research Team (Research Coordinator/Assistant, FPI Officer, CO, Data Assistant, Project
Manager)
Prior to exercise 
1.
Project manager worked with the Research Coordinator/Assistant to identify eligible groups
based on recruitment data as well as follow-up data to ensure groups still meet the eligibility
criteria.

103
2.
Groups were selected based on, (1) sub-counties with the majority of groups, (2) number of
consented group members. 10 groups were selected in Busia County and another 10 groups
were selected in Trans Nzoia County
3.
An appropriate time, date and venue for the exercise was set. The venue was chosen based on
the facility where majority of consented participants seek HIV care. Research
Coordinator/Assistant worked with the health facilities to secure a venue.
4.
The project manager invited the MoH and the AMPATHPlus teams while the Research
Coordinator/Assistant invited the group leaders
5.
All parties acknowledged having received the invitation and confirmed attendance
Randomization exercise 
1.
STO/PO opened the meeting and introductions were done.
2.
Project manager did a recap of the study aims and study procedures with an emphasize on the
fact that this is research and therefore we do not know whether one arm is better than the
other. She also capitalized on the similarities between study Arms A and B which included all
groups having access to the services of the FPI officer, Screening for NCDs at baseline,
Receiving a bucket and handwashing soap from the study.
3.
Project manager explained what randomization is and how it was going to be conducted.
4.
Project manager asked the group leaders to choose which side of the coin represents Study
Arm A and which one represents study Arm B.
5.
Chairpersons from each group were invited to the stand around the table, they were asked to
select one representative to flip the coin who then went ahead to flip the coin to determine
which label i.e. (“1” or “2”) falls under study arm A or B.
6.
5 raffle tickets were labeled “1” & another 5 were labeled “2”.
a.
Raffle numbers “1” and “2” will correspond to Study Arm A or B depending on the
outcome of the flipped coin.
7.
In each county, 10 group leaders from each of the 10 GISHE groups took turns selecting a
raffle ticket.
8.
The group leads then held onto their tickets until all the leads had picked their ticket.
9.
Once all the leads had a ticket, the leads opened their tickets together and show them to the
community attendees.
10. The raffle tickets were randomized into the respective Study Arms based on the label as
aforementioned in 6a
11. Group leads were congratulated and given a chance to ask questions/seek any clarifications
Post Randomization 
1.
Project Manager communicated the randomization outcomes to the larger research team.
2.
Group representative (group leads) present during the randomization communicated the
randomization outcomes to their respective groups.
3.
Align the Return to Care (RTC) dates for all the Study Arm A members.
10. The original Aim 1 analysis plan for the primary outcome (virologic suppression) that is summarized in section 
7.2 of this protocol and in the published protocol (Genberg BL et al. Integrated community-based HIV and non-
communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised 
trial. BMJ Open. 2021 May 18;11(5):e042662. doi: 10.1136/bmjopen-2020-042662.) was revised. Details of the 
revised analysis plan, and reasons for the revision(s), are described in the following paragraphs.

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Revised Analysis plan 
Primary objective: Compare rates of viral suppression between the MF+ICB and MF+UC arms. 
Secondary objective 1: Compare rates of viral suppression between the MF+ICB and UC arms. 
Secondary objective 2: Compare rates of viral suppression between the MF+UC and UC arms. 
Primary outcome definition: Achievement of HIV-1 RNA viral load suppression at 18-months. 
Participants whose 18-month viral load assessment occurred before January 1, 2023 were considered 
virologically suppressed if their viral load was <400 copies/mL. To adhere to changes to Kenya’s national 
recommendations for HIV monitoring cutoffs that occurred during the trial, patients whose 18-month 
viral load assessment was on or after January 1, 2023 were considered suppressed if their viral load was 
<200 copies/mL.  
Analysis set: The analysis set for all objectives is the intent-to-treat set and included all randomized 
participants for arms MF+ICB and MF+UC and all participants that in the UC arm that provided 
informed consent. 
Analysis plan for the primary objective: The analysis of the primary objective was conducted using a 
doubly robust generalized estimating equation with a logit link function accounting for potentially 
differential dropout as described in Prague M et al.7 The generalized estimating equation model included 
the intervention arm, used an independence working correlation matrix and the variance was estimated 
using a sandwich variance estimator for clustered data. The intervention effect was estimated using the 
log odds ratio coefficient of intervention in the generalized estimating equation. The primary hypothesis 
test of the intervention effect was conducted using a Wald test and 95% Wald-based confidence intervals 
were calculated.  
Handling of dropout: Implementation of the method proposed in Prague M et al.7 relies on specifying a 
model for the dropout probability and two outcome models (one for each treatment arm). For the method 
to be a valid way to handle dropout, either the model for the dropout probability or both outcome models 
need to be correctly specified. The model used for the dropout probability was a logistic regression model 
with linear main effects of county, treatment arm, log(viral load at baseline+1)), schooling achieved,  age, 
and gender. The model used for the outcome model in the MF+ICB was a logistic regression model with 
linear main effects of  county, log(viral load at baseline+1)), schooling achieved,  age, and gender and the 
model used for the outcome model in the MF+UC was a logistic regression model with linear main 
effects of  county, log(viral load at baseline+1)), schooling achieved, monthly income,  age, and gender. 
Monthly income was only used in one of the models due to instability of the model fitting when it was 
added to the other models. The dropout weights were well behaved with the largest weight being 1.42; 
therefore, we did not experience any extreme weights and hence made no adjustments to account for
them. 
Handling of missing data: Multiple imputation was used to account for missing data on baseline 
covariates and Rubin’s rule for variance estimation was used for variance estimation.  
7 Prague M, Wang R, Stephens A, Tchetgen Tchetgen E, DeGruttola V. Accounting for interactions and complex 
inter-subject dependency in estimating treatment effect in cluster-randomized trials with missing outcomes. 
Biometrics. Published online 2016. doi:10.1111/biom.12519 

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Stability analysis: We performed stability analysis to determine how sensitive the results were to different 
specifications of the model used in the implementation of the doubly robust generalized estimating 
equation. This was done by modeling continuous covariates using second order polynomials and
including interactions between the covariates. The results were similar to what is presented in the main 
manuscript.  
Analysis plan for secondary objectives: The analyses of both secondary objectives were conducted 
using a doubly robust generalized estimating equation with a logit link function accounting for potentially 
differential dropout and confounding8. The generalized estimating equation models included the 
intervention arm, used an independence working correlation matrix and the variance was estimated using 
a sandwich variance estimator for clustered data. The intervention effects were estimated using the log 
odds ratio coefficient of intervention in the generalized estimating equation. The primary hypothesis tests 
of the intervention effects were conducted using a Wald test and 95% Wald-based confidence intervals 
were calculated. 
Handling of confounding and dropout: Implementation of the method relies on specifying a model for the 
dropout probability and two outcome models (one for each treatment arm) and these procedures account 
for both dropout and confounding (under the assumption of no unmeasured confounding and a non-
informative dropout). All three models were logistic regression models with linear main effects of  
county, log(viral load at baseline+1)), schooling achieved,  age, and gender and the model for dropout 
probability also included the treatment arm. 
Handling of missing data: Multiple imputation was used to account for missing data on baseline 
covariates and Rubin’s rule for variance estimation was used for variance estimation.  
Rational for revisions to original analysis plan: 
We modified the primary outcome definition without looking at the data and to be in compliance with 
national guidelines that changed during the study’s follow-up period. As a sensitivity analysis we reran 
the analysis with the current definition of viral suppression (i.e., <200 copies/mL) used for all 
participants, and the results were very similar to what the primary analysis shows. 
The original analysis plan used a generalized linear model as the primary analysis method. The change in 
the analysis plan was made without looking at within arm data, but was made after the high rate of viral
suppression was known (i.e., overall outcome prevalence was known but no between arm comparisons 
had been done). The reason for the change was: We have partially clustered data as the individuals in 
Arms MF+ICB and MF+UC are in clusters while participants in the UC arm are not. The mixed effects 
model requires correct specification of the distribution assumptions of random effects while the GEE does 
not. As verifying the distribution assumptions on people in a single cluster is impossible, we thought a 
GEE would provide a better approach. A recent manuscript9 compared methods for analyzing partially 
clustered data and concluded “Analysis of partially clustered trials using GEEs with an independence 
working correlation structure may be preferred to avoid the limitations of mixed models and 
exchangeable GEEs” further supporting the change (this was published after the decision was made to 
change the analysis method).   
8 Prague M, Wang R, Stephens A, Tchetgen Tchetgen E, DeGruttola V. Accounting for interactions and complex 
inter-subject dependency in estimating treatment effect in cluster-randomized trials with missing outcomes. 
Biometrics. Published online 2016. doi:10.1111/biom.12519 
9 Lange, K. M., Sullivan, T. R., Kasza, J., & Yelland, L. N. (2024). Performance of mixed effects models and 
generalized estimating equations for continuous outcomes in partially clustered trials including both independent 
and paired data. Statistics in Medicine. 

11. The original definition of the Aim 1 secondary outcome (retention in care) that is 
summarized in section 3.4 of this protocol and in the published protocol (Genberg BL et al. 
Integrated community-based HIV and non-communicable disease care within microfinance 
groups in Kenya: study protocol for the Harambee cluster randomised trial. BMJ Open. 2021 
May 18;11(5):e042662. doi: 10.1136/bmjopen-2020-042662.) was revised. Specifically, the 
secondary endpoint was revised to be measured as a binary variable (rather than as a 
proportion). The revised endpoint defined a participant as always retained in HIV care if they 
attended at least one HIV care visit in each quarter a visit was scheduled, where attending a visit 
was defined as attending a visit within +/- 28 days of their scheduled visit date. This revision was 
made to prevent potential measurement bias between the study arms given that some 
community care recipients had more frequent care visits during the first 6 months of the trial as 
compared to facility (standard) care participants.
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