Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Phase: NA
Conditions: HIV
Sponsor: University of California, San Francisco

 
Agricultural Intervention for Food 
Security and HIV Health Outcomes in 
Kenya 
 
Study Protocol 
 
Document Date: March 27, 2019 
 
NCT02815579 

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1. Title: Shamba Maisha: Agricultural intervention for food security and HIV health 
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outcomes in Kenya 
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2. Investigators and Institutional Affiliations  
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Name 
Organization 
Role on Project 
Craig R. Cohen, MD, MPH 
Department of Obstetrics, Gynecology, 
and Reproductive Sciences, Bixby Center 
for Global Reproductive Health, University 
of California, San Francisco 
Co-Principal 
Investigator 
Sheri D. Weiser, MD, MPH 
Division of HIV/AIDS, San Francisco 
General Hospital, University of California, 
San Francisco, Department of Medicine 
Co-Principal 
Investigator 
Elizabeth A. Bukusi, 
MBChB, MMed, MPH, PhD 
Center for Microbiology Research, 
Kenya Medical Research Institute 
KEMRI Principal 
Investigator 
Shari Dworkin, PhD, MS 
University of California, San Francisco, 
Dept. of Social & Behavioral Sciences 
Co-Investigator 
Edward A. Frongillo, Jr., 
PhD, MS 
Department of Health Promotion, 
Education, and Behavior, Arnold School 
of Public Health, University of South 
Carolina  
Co-Investigator/ 
Biostatistician 
Lisa M. Butler, PhD, MPH, 
MA 
Institute for Collaboration on Health, 
Intervention, and Policy, University of 
Connecticut 
Co-Investigator 
James G. Kahn, MD, MPH 
Dept. of Epidemiology & Biostatistics, 
IHPS, and Global Health Sciences, 
University of California, San Francisco 
Co-Investigator 
Harsha Thirumurthy, PhD, 
MPhill 
Perelman School of Medicine, 
University of Pennsylvania  
Co-Investigator 
Starley Shade, PhD, MPH 
Department of Epidemiology & 
Biostatistics, Division  of Prevention 
Science, University of California, San 
Francisco 
Co-Investigator 
Martin Fisher, PhD 
Kickstart 
Consultant 
 
4 
A. COLLABORATING INSTITUTIONS 
5 
UNIVERSITY OF CALIFORNIA SAN FRANCISCO (UCSF) 
6 
UCSF is the only University of California campus dedicated exclusively to the health 
7 
sciences and is home to graduate professionals in medicine, nursing, pharmacy, and 
8 
dentistry, and a graduate division for pre-doctoral and postdoctoral scientists. In 
9 
addition to its main campus, where the Schools of Medicine, Nursing, Pharmacy, and 
10 
Dentistry and the UCSF Medical Center are located, UCSF encompasses several major 
11 
sites in San Francisco, including UCSF Mount Zion, the Comprehensive Cancer Center, 
12 
and Mission Bay. UCSF is considered one of the United States’ premier health sciences, 
13 
training, and research centers and has a well-established reputation in biomedical 
14 
research.  
15 
UCSF Department of Medicine The Department of Medicine has been the number one 
16 
recipient of research dollars from the National Institutes of Health (NIH) among all departments 
17 
of internal medicine in the nation. Eight of the adult specialty clinical programs are ranked in the 
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top 10 by the US News & World Report - AIDS, Diabetes & Endocrinology, Primary Care, 
19 
Cancer, Kidney Disorders, Pulmonology, Geriatrics and Rheumatology. The department's 
20 
continued success in this highly competitive arena attests to the quality and impact of the 
21 
research performed by its basic and clinical scientists. 
22 
UCSF Department of Obstetrics/Gynecology and Reproductive Sciences: The Department 
23 
boasts a diverse portfolio of research activities, from basic biological, translational, and clinical 
24 
investigation to epidemiological inquiry and the development of public health policy. The 
25 
Department is home to the University of California National Center of Excellence in Women's 
26 
Health. The Department’s exemplary academic reputation (consistently among the top three 
27 
departments of obstetrics and gynecology in the nation to receive federal funding) derives from 
28 
long-standing integrative and multidisciplinary partnerships within the UCSF community of 
29 
nursing and medical scholars.  
30 
UCSF Department of Epidemiology and Biostatistics 
31 
The UCSF Department of Epidemiology & Biostatistics - the largest department of epidemiology 
32 
in the University of California system in terms of full-time primary faculty and the number of 
33 
affiliated faculty.  It aims to carry out its educational, scientific, and clinical missions within the 
34 
highly interdisciplinary culture of UCSF and to take a transdisciplinary approach to education 
35 
and research. 
36 
UCSF AIDS Division:  Positive Health Program (PHP) 
37 
Drs. Sheri Weiser is a faculty member in the PHP/HIV/AIDS Division at San Francisco General 
38 
Hospital. The HIV/AIDS Division is part of the Department of Medicine at UCSF. PHP consists 
39 
of a multidisciplinary HIV/AIDS clinic, an AIDS Inpatient Unit, and a strong clinical research 
40 
program. The program has focused on clinical, research and educational issues of HIV and HIV-
41 
associated illnesses (e.g., sexually transmitted and blood borne infections) for over 25 years. 
42 
Academically, PHP holds weekly clinical grand rounds, monthly research forums and periodic 
43 
seminars, which provide ample opportunity for peer review as well as dissemination of study 
44 
information. The Positive Health Program has become an internationally recognized center of 
45 
clinical excellence and "standard-setter" for HIV care, pioneering a number of medical and 
46 
scientific advances. The treatment model practiced at PHP has been widely adopted around the 
47 
world. PHP has also had a major presence in the developing world, training local providers and 
48 
leading global research. PHP's faculty is among the most cited in scientific publications and 
49 
conducts work in all major areas of HIV science. 
50 
UCSF Center for AIDS Prevention Studies (CAPS) 
51 
Dr. Sheri Weiser holds a secondary appointment at CAPS. The mission of CAPS is to develop 
52 
research focused on three long-term goals: preventing new HIV infections, behavioral 
53 
approaches to optimizing health outcomes among HIV-infected people, and reducing disparities. 
54 
These goals are advanced through multidisciplinary research supported by six cores. CAPS is 
55 
located at 550 16th Street along with the AIDS Research Institute (ARI) administrative offices, 
56 
the Pacific AIDS Education and Training Center (PAETC) and the UCSF program in Global 
57 
Health Sciences (GHS).  CAPS hosts a weekly town hall series, in which scientists from UCSF 
58 
and around the world present findings from their ongoing and recent research. In addition, the 
59 
UCSF Global Health Sciences program (co-located with CAPS) hosts a regular speaker series 
60 
and offers a degree program with classes in epidemiology, biostatistics, and qualitative and 
61 
quantitative behavioral research methods. 
62 
Both CAPS and PHP are programs of the AIDS Research Institute (ARI). The AIDS research 
63 
program at UCSF constitutes an organized set of research activities aimed at all aspects of the 
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epidemic domestically and internationally. ARI is committed to harnessing the extraordinary 
65 
resources of UCSF to advance scientific discovery in the service of fighting HIV/AIDS. UCSF 
66 
faculty represent a mix of expertise in the basic, clinical, prevention, and policy sciences. The 
67 
faculty is internationally renowned for their contributions to immunology, virology, vaccine 
68 
research, pediatrics, genetics, behavioral science, and advanced treatment research. Further, 
69 
UCSF scientists have the expertise in health economics, epidemiology, and health care delivery 
70 
needed to determine how optimal treatments can be integrated into evolving health care 
71 
systems to reach all HIV-affected populations. ARI brings together scientists from the four 
72 
professional schools at UCSF (Medicine, Dentistry, Pharmacy, and Nursing), from the UCSF-
73 
affiliated laboratories (The Gladstone Institute of Virology and Immunology, Blood Centers of the 
74 
Pacific, and the California State Labs), the San Francisco Department of Public Health, and the 
75 
School of Public Health at UC Berkeley. Activities are conducted at all four hospital sites: 
76 
Parnassus, San Francisco General, Mt. Zion, and the SF Veterans Affairs Medical Center. 
77 
UCSF Bixby Center for Global Reproductive Health: The Bixby Center was formed in 1999 
78 
to integrate research and training efforts in contraception and family planning with work in 
79 
sexually transmitted infections (STIs) and HIV/AIDS. Projects and research range from primary 
80 
prevention to treatment interventions and include epidemiologic and behavioral approaches, 
81 
clinical and biomedical research, and public health and policy development, as well as 
82 
leadership training programs. Faculty and staff from diverse disciplines, including medicine, 
83 
epidemiology, public health, sociology and anthropology, use sound science to seek solutions to 
84 
the reproductive health issues of most pressing concern to women, men and youth in the United 
85 
States and internationally. 
86 
 
87 
UCSF Department of Social & Behavioral Sciences, School of Nursing: The Department 
88 
of Social and Behavioral Sciences (SBS) research mission is to advance knowledge through 
89 
theory and research; to design and evaluate the organization, financing, and delivery of health 
90 
care; and to examine one broad dynamics of health, healing, and the production of knowledge 
91 
and its application in these domains.  
92 
UC GLOBAL HEALTH INSTITUTE (UGCHI) 
93 
UCGHI advances the mission of the 10-campus University of California system to improve the 
94 
lives of people in California and around the world. By stimulating education, research, and 
95 
partnerships, UCGHI leverages the diverse intellectual resources across the University to train 
96 
the next generation of global health leaders and accelerate the discovery and implementation 
97 
of transformative global health solutions.  UCGHI includes three Centers of Expertise (COE), 
98 
including the COE in Women’s Health & Empowerment (WHE).  The COE in WHE believes 
99 
that advances in women’s health globally are impeded by poverty, limited access to 
100 
educational and economic opportunities, gender bias and discrimination, unjust laws, and 
101 
insufficient state accountability. By prioritizing women’s health concerns, rights, and 
102 
empowerment, this COE is uniquely poised to catalyze societal-level changes that will yield 
103 
sustainable improvements in health and well-being for women on a global scale.   
104 
KENYA MEDICAL RESEARCH INSTITUTE (KEMRI) 
105 
The Kenya Medical Research Institute (KEMRI) is one of the leading health research institutes 
106 
in Africa. KEMRI was established in 1979 under the Science and Technology (Amendment) Act 
107 
of that year to represent the national body responsible for carrying out health science research 
108 
in Kenya. KEMRI’s mission is to conduct health research and generate research findings to be 
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applied towards improvement of health in Kenya and the world over. Under the Amendment Act, 
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KEMRI was charged with the responsibility of carrying out health research with the following 
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mandates:    
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1. To carry out research in the field of biomedical sciences;   
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2. To co-operate with other organizations and other institutions of higher learning in training 
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programs and on matters of relevant research;   
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3. To liaise with other research bodies within and outside Kenya carrying out similar 
116 
research;   
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4. To disseminate research findings;   
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• 
To co-operate with the Ministry of Health, the Ministry responsible for research, the 
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National Council for Science and Technology, and the Medical Science Advisory 
120 
Committee on matters pertaining to research policies and priorities.    
121 
 
122 
With health research and training expertise in infectious disease, parasitic disease, 
123 
epidemiology, and biotechnology and non-communicable diseases, KEMRI has grown to 
124 
become one of the leading centers of excellence in health research development and Africa’s 
125 
largest health research institute. KEMRI has trained cadres of professionals and maintains over 
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80 professors with PhD degrees or equivalent, over 148 with MA or equivalent, and nearly 400 
127 
highly trained and skilled technical staff. As a partner in global health initiatives, KEMRI 
128 
collaborates with the World Health Organization (WHO), the Japan International Cooperation 
129 
Agency (JICA), U.S. Center for Disease Control and Prevention (CDC), among others. KEMRI 
130 
serves as the Collaborating Center for HIV/AIDS, Tropical Research, Polio Immunization, Viral 
131 
Hemorrhagic Fevers, and Anti-Microbial Resistance.    
132 
Research, Training, and Care Program (RTCP), KEMRI 
133 
Drs. Bukusi and Cohen with others established the Research, Training, and Care Program 
134 
(RTCP) with KEMRI and the University of Nairobi in 1994. Through this collaboration, Dr. Cohen 
135 
and Dr. Elizabeth Bukusi (KEMRI) established the Research, Care, and Treatment Program 
136 
(RCTP), a program with research projects in Nyanza Province and Nairobi, Kenya.  In 2007, 
137 
RCTP became registered as an NGO in Kenya and in 2013, the name of the NGO was changed 
138 
to RCTP-FACES.  In addition to facilitating collaborative research on STIs and HIV treatment 
139 
and prevention between investigators from the US and Kenyan counterparts, the mission of 
140 
RCTP-FACES is to provide administrative management of the biomedical research conducted 
141 
by researchers from KEMRI, UCSF, and other collaborating institutions. The largest RCTP-
142 
FACES program is the PEPFAR/CDC-funded Family AIDS Care and Education Services 
143 
(FACES) program, which works with the government of Kenya to strengthen comprehensive 
144 
HIV prevention, care, and treatment service delivery and expand primary prevention efforts in 
145 
Nyanza and Nairobi Provinces. 
146 
UNIVERSITY OF SOUTH CAROLINA (USC) 
147 
Established in 1801, USC is a full-service, state-supported research university that includes the 
148 
358-acre Columbia campus and seven regional campuses with a total full-time student body 
149 
population of more than 39,500 and 2,100 full-time faculty members. USC offers a broad 
150 
spectrum of educational opportunities with 14 colleges and schools that encompass 324 
151 
undergraduate and graduate degree-granting programs. 
152 
The Arnold School of Public Health (ASPH) Based at USC's main campus in Columbia,  
153 
ASPH is one of 49 schools of public health fully accredited by the Council on Education for 
154 
Public Health (CEPH), and is accredited through 2017. Dr. Edward Frongillo is a professor and 
155 
chair of the Department of Health Promotion, Education, and Behavior (HPEB) at the USC. This 
156 
department has as its focus understanding how policy, environmental, institutional, and 
157 
individual actions can improve the public’s health. This work, usually done in partnership with 
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organizations and communities, uses principles and methods from the social and behavioral 
159 
sciences to promote health in diverse settings across South Carolina, the US, and the globe. 
160 
UNIVERSITY OF PENNSYLVANIA 
161 
Academic life at the University of Pennsylvania, Penn, is unparalleled, with 100 countries and 
162 
every U.S. state represented in one of the Ivy League’s most diverse student bodies. 
163 
Consistently ranked among the top 10 universities in the country, Penn enrolls 10,000 
164 
undergraduate students and welcomes an additional 10,000 students to our world-renowned 
165 
graduate and professional schools.  Penn is one of the world's most powerful research and 
166 
teaching institutions, with a research budget last year of nearly $1 billion and more than 4,000 
167 
active faculty members. The scale and interdisciplinary character of research and teaching sets 
168 
Penn apart, and our highly ranked Perelman School of Medicine is one of the top recipients of 
169 
NIH funding in the country. 
170 
Department of Medical Ethics and Health Policy at the Perelman School of Medicine 
171 
The Department is one of the premier institutions of research and education in medical ethics 
172 
and health policy in the world. The Department's distinguished faculty produce and disseminate 
173 
scholarship and lead three bioethics master’s degree programs. In addition to their own 
174 
projects, faculty members supervise research being carried out by undergraduates, graduate 
175 
students, medical students, doctoral students and post-doctoral fellows. The 
176 
Department’s presence in the world of biomedical ethics education is ever-growing.   In 2017, 
177 
the department will launch the Master of Health Care Innovation, an online master's program 
178 
aiming to training future leaders in health policy, administration, and ethics. 
179 
UNIVERSITY OF CONNECTICUT 
180 
The University of Connecticut is one of the top public research universities in the United States, 
181 
with more than 30,000 students pursuing answers to critical questions in labs, lecture halls, and 
182 
the community. Knowledge exploration throughout the University’s network of campuses is 
183 
united by a culture of innovation. An unprecedented commitment from the state of Connecticut 
184 
ensures UConn attracts internationally renowned faculty and the world’s brightest students. As a 
185 
vibrant, progressive leader, UConn fosters a diverse and dynamic culture that meets the 
186 
challenges of a changing global society. 
187 
The Institute for Collaboration on Health, Intervention, and Policy 
188 
The University of Connecticut’s Institute for Collaboration on Health, Intervention, and Policy 
189 
(InCHIP) is a multidisciplinary research institute dedicated to the creation and dissemination of 
190 
new scientific knowledge and theoretical frameworks in the areas of health behavior, health 
191 
behavior change, and health intervention and prevention at multiple levels of analysis (e.g., 
192 
individual, environmental, social, and policy). InCHIP researchers lead novel, influential health 
193 
behavior change initiatives at UConn, institutions across the United States, and globally in 
194 
countries including Albania, Brazil, China, Kenya, Ethiopia, India, Mozambique, South Africa, 
195 
Russia, Uganda, and Vietnam. Our investigators have expertise in the areas of HIV prevention 
196 
and treatment adherence, diabetes management, cancer prevention and control, nutrition, 
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pharmacology, substance abuse, obesity, autism, digital health technologies, school and child 
198 
health, and complementary and alternative approaches to medicine, among other health 
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domains. 
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KICKSTART 
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KickStart, an international NGO, developed a low-cost micro-irrigation pump which is purchased 
202 
by local entrepreneurs and used to establish small agricultural businesses. These pumps 
203 
enable farmers to irrigate their crops year-round avoiding dependence on seasonal rainfall thus 
204 
capitalizing on higher crop prices in the marketplace. KickStart has been one of the leaders in 
205 
micro-irrigation technologies since 1991, through the development and sales of manually 
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operated “MoneyMaker” pumps, which are now widely available in Kenya. 
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3. ABSTRACT 
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Despite major advances in care and treatment for those living with HIV, morbidity and mortality 
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among people living with HIV/AIDS (PLHIV) remain unacceptably high in sub-Saharan Africa 
212 
(SSA), largely due to the parallel challenges of poverty and food insecurity.  Food insecurity and 
213 
poverty contribute to higher morbidity and mortality among PLHIV, and there has been 
214 
increasing international recognition of the need to address these factors for a successful global 
215 
response to the HIV epidemic. Yet, to date there have been few studies to systematically 
216 
evaluate the impact and cost-effectiveness of promising food security interventions on health 
217 
outcomes among PLHIV. To address these gaps, together with KickStart, a non-governmental 
218 
organization based in SSA, we have developed a multisectoral intervention in Nyanza Region, 
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Kenya that includes: a) a loan (~$175) for purchasing agricultural implements and commodities; 
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b) agricultural implements to be purchased with the loan including a human-powered water 
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pump, seeds, fertilizers and pesticides; and c) education in financial management and 
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sustainable farming practices. We successfully completed a pilot intervention trial that showed 
223 
that the intervention was feasible, acceptable and may improve HIV-related health. We now plan 
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to conduct a cluster randomized controlled trial (RCT) of this intervention with the following 
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specific aims: Aim 1: To determine the impact of a multisectoral agricultural intervention among 
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HIV-infected farmers on ART on HIV clinical outcomes. We hypothesize that the intervention will 
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lead to improved viral load suppression (primary outcome) and decreased HIV-related morbidity 
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in the intervention arm compared to the control arm. Aim 2: To understand the pathways through 
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which the multisectoral intervention may improve HIV health outcomes. Using our theoretical 
230 
model, we hypothesize that the intervention will improve food security and household wealth, 
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which in turn will contribute to improved outcomes through nutritional (improved diet quality, 
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nutritional status), mental health (less depression, improved empowerment), and behavioral 
233 
(improved ART adherence, and retention in care) pathways. Aim 3: To determine the cost-
234 
effectiveness of the intervention and obtain the information necessary to inform scale-up in 
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Kenya and similar settings in SSA.  We hypothesize that the intervention will be cost-effective, 
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and that we will be able to translate lessons learned into successful scale up. To accomplish 
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Aims 1 & 2, we will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 
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ratio to the intervention and control arms, and enroll up to 65 participants per facility (total up to 
239 
n=1,040). All participants will be followed for 2 years. To accomplish Aim 3, we will: a) conduct a 
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cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from 
241 
the intervention (e.g., gender, education, family size, wealth, risk tolerance, etc.); and c) perform 
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a mixed-methods process evaluation to guide future scale-up efforts of the intervention. Our 
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ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and 
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HIV/AIDS morbidity and mortality in SSA.  
 
245 
 
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4. LAY SUMMARY 
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We plan to test the hypothesis that a multisectoral agricultural and finance intervention will 
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improve food security, prevent antiretroviral treatment failure, and reduce co-morbidities among 
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people living with HIV/AIDS. 
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5. BACKGROUND 
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HIV/AIDS and food insecurity are two of the leading causes of morbidity and mortality in 
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sub-Saharan Africa (SSA).1-6 There are an estimated 35.3 million people living with HIV/AIDS 
254 
(PLHIV) worldwide, 70.8% of whom live in SSA.7 Food insecurity, defined as ”the limited or 
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uncertain availability of nutritionally adequate, safe foods or the inability to acquire personally 
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acceptable foods in socially acceptable ways,”8 is also highly prevalent in SSA. As of 2013, 223 
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million people were food insecure in SSA, an estimated 25% of the population.9 Food insecurity 
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in the region stems from the combined effects of extreme poverty, infections, environmental 
259 
change, insufficient agricultural output, rising food prices, and high rates of population 
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growth.10,11 While the agricultural sector accounts for 51% of Kenya’s gross domestic product 12, 
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crop productivity is low because of limited irrigation, unreliable rainfall patterns, and land that is 
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highly depleted of nutrients.13 At the same time, food prices have increased since 1995 due to 
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globalization, economic shifts and human conflict.11 The prevalence of Critical Food Poverty 
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(pCFP) (the proportion of the population whose daily income is lower than the cost of a 
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macronutrient-balanced food basket that meets minimum dietary needs) in the Nyanza Region 
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of Kenya is 28%, exceeding the national average.14 The prevalence of food insecurity is even 
267 
higher among PLHIV in SSA. Studies from Kenya and Uganda have found that 70% or more of 
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PLHIV are moderately or severely food-insecure.15-17  
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Food insecurity and HIV/AIDS are intertwined through biological, behavioral, and socio-
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economic pathways. Our novel evidence-based causal framework (Figure 1) builds upon our 
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previously-published conceptual framework18,19 adapted from existing theoretical models for 
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understanding the linkages between HIV/AIDS, food security, and socio-economic well-
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being.3,18,20-22 The bi-directional linkages between HIV/AIDS and food insecurity are embedded 
274 
within a context of weak healthcare systems, poor agricultural infrastructure, and entrenched 
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poverty. These structural determinants of health interact to create a vicious cycle of household 
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poverty, food insecurity, and ill-health.20,22 Each condition heightens the vulnerability to, and 
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worsens the severity of the other. For example, if a household affected by HIV/AIDS has few 
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agricultural skills, they may experience food insecurity and poverty (A1, A2) leading to 
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malnutrition (A4a), decreased ART adherence (A4b), poor mental health (A4c), and 
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disempowerment (A4d). These, in turn, can worsen immunologic and virologic responses, and 
281 
lead to increased morbidity and mortality (A3). Likewise, when a household loses a family 
282 
member to HIV-related illness or death, they are less able to produce agricultural outputs and 
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may sell off household assets as a source of income. This further cements families into the 
284 
cycle of poverty and food insecurity (A5, A6). In the sections that follow, we provide evidence for 
285 
each linkage in our causal framework. 
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Food insecurity and poverty are key contributors to poor health outcomes among PLHIV 
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receiving treatment. In studies by our group and others, food insecurity has been associated 
288 
with a range of adverse clinical effects among PLHIV on ART, including declines in physical 
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health status,16,23,24 decreased viral suppression,25-28 worse immunologic status,23,25,29,30 
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increased incidence of serious illness,16,31,32 and increased mortality. 33,34 In several longitudinal 
291 
analyses, we found that after controlling for clinical and socioeconomic variables, HIV-infected 
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people who were food insecure were 50%-95% more likely to die compared with individuals who 
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were not food insecure.33,34 Studies have also documented negative health impacts of other 
294 
indicators of low socioeconomic status (SES) for HIV.35 For example, in a prospective cohort 
295 
study in Uganda, we found that lack of education, unemployment and lower wealth index were 
296 
associated with mortality.36 In Kenya, we have demonstrated an association between low SES 
297 
and lower CD4 increase upon ART initiation.37  
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Food insecurity and poverty can impact HIV outcomes through four mediating pathways: 
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nutritional, behavioral, mental health and empowerment (Figure 1).  
300 
1) Nutritional pathways: Food insecurity is associated with macronutrient and micronutrient 
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malnutrition,38,39 and malnutrition in turn has been shown to hasten progression to AIDS and 
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death.40-43   Among HIV-infected individuals, weight loss, low body mass index (BMI), and low 
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albumin have been shown to predict opportunistic infections, immunologic decline, and shorter 
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survival time in both untreated and ART treated individuals.44-52 HIV increases metabolic 
305 
requirements50,53 and is associated with diarrhea and malabsorption of fat and carbohydrates,53-
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56 which further compounds the links between malnutrition and disease progression. Also, lack 
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of food may impede optimal absorption of 
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certain ARVs,57-59 which may contribute to 
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treatment failure. Additionally, oxidative 
310 
stress caused by micronutrient deficiencies 
311 
may cause HIV viral loads to increase.60  
312 
Poverty and nutrition have also been 
313 
closely linked in a number of studies 
314 
conducted in developing countries. In 
315 
Kenya we have shown that higher SES – 
316 
achieved as a result of ART initiation – led 
317 
to increased nutritional status.61 Other 
318 
studies have also shown that economic 
319 
shocks, that make households fall below 
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the poverty line, result in poorer nutrition.62 
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2) Behavioral pathways: Studies from our group and others have shown that food insecurity and 
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poverty indicators are consistently associated with ART non-adherence and treatment 
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interruptions,63-72 which are both well-known determinants of HIV treatment outcomes. 73-80 Food 
324 
insecurity and poverty contribute to non-adherence in SSA because of competing demands 
325 
between costs of food, basic needs, and medical expenses, and because of worsened ART side 
326 
effects in the absence of food,65,67 In addition to ART non-adherence and treatment 
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interruptions, individuals who struggle with food insecurity and poverty often miss scheduled 
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clinic visits, and may have decreased uptake of ART.16,81 In rural Uganda, we reported that 
329 
severe food insecurity was associated with decreased outpatient clinic visits, 16 and our other 
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work in Uganda provided support for the hypothesis that poverty contributes to lower retention in 
331 
care.82 In Uganda, participants in a cohort study reported foregoing food in order to obtain ART 
332 
(83%), access outpatient care (76%) and access inpatient care (44%).16 This suggests that the 
333 
relatively high levels of adherence reported among ART-treated individuals in SSA83-85 may not 
334 
be sustainable unless reduction of food insecurity and poverty become essential components of 
335 
comprehensive HIV care programs. Interventions aimed at improving food insecurity and 
336 
economic status may contribute to better ART adherence and retention outcomes. 
337 
3. Mental health pathways: Food insecurity has been found to be associated with poor mental 
338 
health status independent of other indicators of low socioeconomic status.86,87 Specifically, it has 
339 
been associated with anxiety,88 depression,86 and stress.88,89 Among PLHIV, we have published 
340 
several studies demonstrating that food insecurity is associated with depression and poor 
341 
mental health status in SSA and elsewhere.31,33,90 A number of studies have also documented 
342 
that poverty has a negative, causal effect on mental health among PLHIV.91-93 The mental health 
343 
consequences of food insecurity and poverty can contribute to lower ART adherence and worse 
344 
HIV clinical outcomes.94-97 Even after adjusting for ART adherence, depression has been 
345 
associated with worsened HIV treatment outcomes, including CD4+ T-lymphocyte count 
346 
decline,94 increased probability of AIDS-defining illness,98 and AIDS-related mortality.94 The role 
347 
of depression in accelerating disease progression is strengthened by the fact that the treatment 
348 
of depression has been demonstrated to improve ART adherence99 and viral suppression.99 
349 
Together, these data suggest that improving the food security and economic status of ART 
350 
patients should result in better mental health outcomes, which in turn can contribute to better 
351 
HIV clinical outcomes. 
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4. Empowerment pathways: Food insecurity and poverty also contribute to lower levels of 
353 
empowerment, including women’s empowerment, which can negatively impact health outcomes 
354 
for HIV.  Often dependence on male partners for food and other resources disempowers women 
355 
by making it difficult to exercise control in household or sexual decision-making.  In qualitative 
356 
and quantitative studies from our group from Uganda, Botswana and Swaziland, we found that 
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lack of food impeded women’s ability to refuse sex or to insist on condom use.100,101 For 
358 
example, in Botswana and Swaziland, we found that women who were food insecure reported 
359 
lower control over sex, and experienced twice the odds of sexual victimization in the past 
360 
year.101,102 Research also suggests that low sexual relationship power is associated with 
361 
adverse physical and mental health outcomes.103-106  In Uganda, we have shown that, among 
362 
HIV-infected women low sexual relationship power is associated with malnutrition, 103 
363 
depression,107 and worse virologic outcomes.106 
364 
Morbidity and mortality from HIV/AIDS poses adverse social and economic 
365 
consequences for households with HIV, perpetuating the vicious cycle of food insecurity, 
366 
poverty and HIV/AIDS.108,109 Households affected by HIV/AIDS lose income, assets, and skills 
367 
when working-age adults fall ill, and the subsequent treatment and funeral costs can be doubly 
368 
catastrophic.110-119 National survey data from Kenya indicate that the net value of household 
369 
crop production declines by 68% following the death of a male household head, and that 
370 
affected households adopt short-term survival strategies (such as selling off productive assets 
371 
and shifting from high-value to subsistence crops) that impair financial viability in the long 
372 
term.120 Furthermore, intergenerational transmission of poverty and food insecurity occurs when 
373 
children are withdrawn from school to provide informal care or to compensate for lost 
374 
labor.61,121,122 Put differently, the epidemic represents a decade-long setback in human capital 
375 
accumulation in Kenya.123 
376 
PLHIV may be particularly susceptible to food insecurity and poverty and are least able 
377 
to rely on social support for assistance when faced with health and agricultural shocks. 
378 
Borrowing and other transfers from kin and social networks serve as a source of informal 
379 
insurance against shocks.124-127 Due to higher poverty and greater stigma, however, HIV-
380 
affected households are generally less capable of drawing on these informal sources of support 
381 
when faced with shocks.128 As a result, HIV-affected households may be even more susceptible 
382 
to worsening food insecurity.129  Livelihood strategies are needed to improve both food security 
383 
and HIV-related stigma, helping to interrupt the cycle of food insecurity and poor health.130 
384 
Given the evidence base, there is a critical need to develop cost-effective structural 
385 
interventions that address food insecurity and poverty to reduce HIV morbidity and 
386 
mortality for PLHIV receiving care. Although allocation of international resources towards HIV 
387 
treatment and care programs in Africa has increased, food insecurity can significantly 
388 
compromise the effectiveness of these programs.131 As more individuals are initiated on 
389 
treatment, the importance of addressing food insecurity and poverty for achieving good clinical 
390 
outcomes will likely grow. As a result, the World Health Organization, UNAIDS and the World 
391 
Food Programme have recommended integrating sustainable food production strategies into 
392 
HIV/AIDS programming.132-135 Specifically, UNAIDS calls for international partners to “fund 
393 
multisectoral HIV programming that incorporates effective food and nutrition interventions, in 
394 
line with scale-up towards universal access to treatment, care and support.”136 Yet, little 
395 
research exists to test the effect of food security or sustainable agricultural interventions on HIV 
396 
clinical outcomes among PLHIV in Africa or elsewhere. Furthermore, economic efficiency is 
397 
increasingly important in the context of structural interventions to address food insecurity and 
398 
HIV treatment. Today’s strained global economic climate imposes practical constraints on goals 
399 
for expanded use of ART.137-139 The mismatch between global health goals and resources calls 
400 
for close examination of promising means to obtain maximum health benefits using available 
401 
funds.  
402 
Existing approaches to impacting HIV treatment outcomes via food security and poverty 
403 
alleviation have numerous limitations. Economic, health and agricultural programs have 
404 
historically been highly compartmentalized and poorly coordinated.140-142 Several small studies 
405 
using macronutrient supplementation have demonstrated that directly addressing food security 
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can improve health outcomes among PLHIV, including ART adherence and nutritional 
407 
status.131,143-150 Yet, a recent Cochrane review identified that there are no RCTs conducted in 
408 
developing countries examining the impacts of either macronutrient supplementation or 
409 
sustainable food production strategies on HIV morbidity and mortality.151 Additionally, 
410 
macronutrient supplementation is limited in scalability,152 does not address all of the 
411 
downstream health consequences of food insecurity, and perpetuates dependency on health 
412 
and assistance programs.147 Moreover, relying on clinics for food may be socially unacceptable 
413 
and may contribute to ongoing anxiety about food supply. Livelihood interventions that address 
414 
the root causes of food insecurity have a better chance of sustainably improving health 
415 
outcomes by addressing the nutritional, mental health and behavioral pathways through which 
416 
food insecurity negatively impacts HIV-related health. Likewise, while microcredit programs can 
417 
improve health and prevent disease acquisition by helping to address poverty and gender 
418 
inequality,153-155 these have been criticized in terms of their effectiveness as a stand-alone 
419 
strategy. As a result, experts have recommended an integration of finance and other livelihood 
420 
approaches to maximize health and reduce poverty.156,157 Income generating activities are well-
421 
suited to improving food security due to a strong empirical relationship between income and 
422 
food consumption,158,159 and to retaining patients in HIV care.131,160 Agricultural interventions 
423 
have significant potential to improve health since the sector is a primary source of income in 
424 
many parts of SSA; in Kenya, agriculture accounts for >75% of the total workforce, and 51% of 
425 
the GDP.12 Randomized trials are urgently needed to test the impacts of combined livelihood 
426 
and microcredit interventions on PLHIV health.   
427 
Preliminary data 
428 
A. In our Shamba Maisha feasibility study, we have shown that a similar intervention 
429 
using agricultural training, microfinance and the KickStart pump was feasible and 
430 
acceptable, and improved income and clinical outcomes. In 2007- 2008, FACES, in 
431 
collaboration with KickStart, carried out a feasibility study with 30 HIV-positive patients in 
432 
Kisumu, Kenya.161 Mean annual income increased by $1,332 (range $1,187 - $2,518) over 
433 
baseline, and mean CD4 count increased by 95.5 ± 139.2 cells/mcL.161 At baseline, 27% of 
434 
individuals had BMI<18.5 compared with 13% at follow-up.161   
435 
B. In our Shamba Maisha pilot intervention study (R34MH094215; Cohen/Weiser, PIs; 
436 
Bukusi site PI; Dworkin co-I), we have shown the current intervention to be feasible and 
437 
acceptable. In 2012-213, UCSF and FACES, in collaboration with KickStart, carried out a pilot 
438 
study of the proposed intervention with 140 HIV-positive patients at two district hospitals in the 
439 
Nyanza Region, one randomized to the intervention (n=72 participants) and one to the control 
440 
arm (n=68 participants). Eligibility criteria and the intervention were the same as the current 
441 
study (see C5a). Enrollment of the 140 participants took only four months, and the screening-to-
442 
enrollment ratio was similar between study arms. Thus enrollment into the control conditions did 
443 
not appear to mitigate interest in study participation. Four participants withdrew from the study 
444 
(98% retention).  Only one of the 72 participants in the intervention arm failed to save the down 
445 
payment for the loan and was withdrawn from the study. All intervention participants completed 
446 
the agricultural and finance training, and found these trainings to be beneficial.  Together, these 
447 
findings have important implications concerning the feasibility for advancing the intervention into 
448 
a definitive cluster randomized controlled trial.  
449 
C. In our Shamba Maisha pilot R34 study, the intervention improved food security, HIV 
450 
clinical outcomes, and child nutrition outcomes. Using difference-in-difference mixed-effect 
451 
models, when compared to the control arm, participants enrolled in the intervention arm had 
452 
statistically significant improvements in food security (3.6 scale points higher, p<0.001),  
453 
frequency of food consumption (9.4 times per week greater frequency, p=0.013) and self-
454 
confidence (p=0.004). Even though the study was not powered for HIV clinical outcomes, we 
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also found statistically significant improvements in CD4 cell counts (165 cells/mm3, p<0.001) 
456 
and proportion virologically suppressed in the intervention arm compared to the control arm 
457 
(comparative improvement in proportion of 0.33 suppressed, (OR 7.6, 95% CI: 2.2-26.8). 
458 
Children <5 years who resided in intervention-arm households (n=97) had significantly larger 
459 
increases in height-for-age Z-scores compared to children in the control arm (n=100) (p=0.04). 
460 
Weight-for-age Z-score declined in the control arm over time but not in the intervention arm 
461 
(p=0.01). While these results are promising, with only two hospitals randomized to the 
462 
intervention or control, it is difficult to definitely separate intervention effects from cluster-level 
463 
variables, highlighting the need for the proposed RCT.  
464 
In a concurrent longitudinal qualitative study (n=60), participants in the intervention arm 
465 
described notable improvements in food security, income and HIV-related health, including 
466 
improved energy and fewer symptoms of illness compared to before initiating the intervention. 
467 
Participants described improved health through nutritional, behavioral, mental health and 
468 
empowerment pathways, in line with our theoretical framework (Figure 2, and Appendix 1). 
469 
Nutritional pathway: Food quantity and diet quality improved and led to weight gain as a result of 
470 
a) increased consumption of fresh fruits and vegetables from their farms; and b) increased 
471 
income from selling produce, which was then used to purchase foods such as meat and grains. 
472 
Behavioral pathway: Participants 
473 
missed fewer clinic visits by using 
474 
money earned from selling produce 
475 
for transportation. Some reported 
476 
better ART adherence because of an 
477 
improved food supply resulting in 
478 
fewer medication side effects. 
479 
Mental health pathway: Participants 
480 
reported improved mood and fewer 
481 
symptoms of depression, as they 
482 
became more active members of the 
483 
community, were better able to 
484 
financially support their family, and 
485 
had less anxiety about household 
486 
food supply. Participants also 
487 
described more hope for the future. 
488 
Empowerment pathway: Due to improved health and work productivity, participants described a 
489 
transformation in their identity from “patients living with HIV” to productive “farmers.” Since 
490 
joining Shamba Maisha, they were consulted by neighbors on farming techniques leading to 
491 
increased visibility, influence, and engagement in community networks. Women’s empowerment 
492 
increased in several domains: a) improved equity over decision-making related to agricultural 
493 
production, sales, and finances; b) improved control over intra-household resource distribution, 
494 
and c) increased control over sexual relationships. These changes were most notable when 
495 
women were responsible for bringing the intervention into the household.  
496 
Our team has extensive experience in conducting complex research and large clinical 
497 
programs in the region, including recruiting and retaining intervention cohorts. FACES 
498 
(CDC PS001913-01; PI C. Cohen; site PI E. Bukusi) is a PEPFAR-supported program that 
499 
provides HIV care, treatment and prevention services and has enrolled more than 136,020 
500 
adults and children at 124 health facilities in Homa Bay, Migori, and Kisumu counties. The 
501 
FACES program serves as the platform for over 12 clinical and implementation research studies 
502 
conducted by teams from UCSF and the Kenya Medical Research Institute (KEMRI) including 
503 
the Shamba Maisha pilot study and proposed cluster RCT. In one trial called “Sustainable East 
504 
Africa Research for Community” (Site PIs: C. Cohen and E. Bukusi; co-Is Drs. Kahn and 
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Thirumurthy), our team is contributing to a multi-site community RCT (enrolled over 335,000 
506 
individuals) that will quantify the health and economic impact of early HIV diagnosis and 
507 
immediate ART using a streamlined care delivery system in 32 rural communities in East Africa. 
508 
Our team has also conducted a cluster RCT (PI: C. Cohen; Site PI: E. Bukusi) that showed that 
509 
integrating family planning services into HIV care is associated with increased use of more 
510 
effective contraceptive methods (sterilization, intrauterine device, implant, injectable or oral 
511 
contraceptives).162 We have also carried out two large HIV prevention trials among discordant 
512 
couples in Kisumu (site-PIs, C. Cohen and E. Bukusi).  Each study had at least 94% of 
513 
participants retained after 24 months of follow-up.163,164  
514 
We have been leaders in research documenting negative health impacts of food 
515 
insecurity on HIV health outcomes. Dr. Weiser (along with Drs. Frongillo, Cohen, and Butler) 
516 
has published 30 manuscripts in peer- reviewed journals describing impacts of food insecurity 
517 
on HIV health outcomes, mental illness, adherence, and women’s empowerment (see sections 
518 
A3, A4, A5 for details) in SSA and elsewhere.  These include: a) longitudinal studies linking food 
519 
insecurity with poor ART adherence and worse virologic and immunologic outcomes;25,165 b) 
520 
longitudinal studies showing that food insecurity is associated with increased measures of 
521 
morbidity (opportunistic infections, physical health status), acute care utilization 
522 
(hospitalizations, acute care visits) 16,32  and higher mortality among HIV-infected 
523 
individuals.34,166 One of Drs. Weiser’s and Butler’s articles published in PLoS Medicine won the 
524 
NIH/Council of Science Editors Award for the Global Theme Issue on Poverty and Human 
525 
Development and was chosen among more than 1000 articles published in 235 journals. 101 
526 
Based on the above work, Drs. Weiser, Frongillo, and Cohen published several review papers 
527 
and a theoretical framework that forms the basis for our framework for the current study.19,167 18  
528 
We have experience evaluating health impacts of food insecurity and economic 
529 
interventions.  In Kenya, Drs. Weiser, Cohen and Bukusi have demonstrated that patients 
530 
enrolled in the food by prescription program achieved greater gains in BMI compared to those 
531 
not enrolled.15 Dr. Frongillo has been a leader in documenting impacts of food insecurity 
532 
interventions on nutrition and health in Burkina Faso,168 Bangladesh,169-172 and the US.173  The 
533 
longitudinal studies in Burkina Faso and Bangladesh174 had 99.2% and 90.4% retention rates, 
534 
respectively, after two years. Dr. Thirumurthy has led studies of the effects of 
535 
structural/economic interventions such as cash transfers on health outcomes in Kenya.175 The 
536 
novel intervention we are proposing here will build on the team’s experience with these previous 
537 
interventions as well our prior pilot study.  
538 
Our group has experience measuring empowerment, studying the linkages between 
539 
gender empowerment, food insecurity and health outcomes, and studying microfinance 
540 
interventions.  Drs. Weiser and Dworkin developed a compendium of measures of 
541 
empowerment for the UC Global Health Institute Center of Expertise on Women’s Health & 
542 
Empowerment. Drs. Weiser, Butler, and Dworkin have shown that food insecurity and poverty 
543 
contributes to lower levels of empowerment for women,100,176 and that low sexual relationship 
544 
power is associated with malnutrition and depression.107,177 In reviews of structural interventions 
545 
for HIV prevention, Dr. Dworkin has shown how women’s economic independence through 
546 
microfinance contributes to improved sexual negotiation, safer sex and decreased gender-
547 
based violence.178,179 In a rigorous meta-analysis examining the impacts of economic programs 
548 
on women’s empowerment, Dr. Dworkin and colleagues found that women’s economic groups 
549 
have a positive and statistically significant impact on women’s economic and social 
550 
empowerment. 180  
551 
We are leaders in research on the intersection between economic variables and 
552 
HIV/AIDS, and in evaluating cost-effectiveness. Dr. Thirumurthy has extensive experience in 
553 
the measurement of poverty and economic status among rural households in Kenya and 
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Uganda. He has led analyses of the economic impact of HIV-associated health deterioration as 
555 
well as ART-induced health improvements in individual productivity and on a broad array of 
556 
socio-economic outcomes at the individual and household level.25,37,181-185 Our team has also 
557 
documented an association between the CD4 cell count of HIV-infected adults and their 
558 
economic status.186  Dr. Kahn has led the development of novel approaches to perform cost-
559 
effectiveness analysis in the context of HIV care, treatment and prevention, and has 
560 
collaborated with Dr. Thirumurthy on cost-effectiveness analyses in East Africa related to 
561 
HIV/AIDS. 61,186-189 In Tororo, Uganda, he assessed a safe water intervention ($1,252 
562 
dollars/disability-adjusted life year [DALY] averted)190 and ART ($597 per DALY averted). In 
563 
South Africa, he found that expanding ART to CD4 count <350 cells/μL would prevent 15% of 
564 
new HIV infections, deaths, and DALYs, with savings of $4 billion over 40 years. He assessed 
565 
the cost-effectiveness of ART across 45 clinics in Zambia, finding $833 per DALY averted 
566 
compared to cotrimoxazole alone.191 Recently, he assessed the cost-effectiveness of integrated 
567 
community health campaigns in 70 countries, finding $49 per DALY averted for the 10 countries 
568 
with the most favorable cost-effectiveness.192  
569 
6. JUSTIFICATION 
570 
The proposed cluster RCT will be the first definitive study to our knowledge to evaluate whether 
571 
a multisectoral agricultural and finance intervention aimed to improve food insecurity and 
572 
household economic indicators will lead to direct health benefits for HIV-infected persons. This 
573 
will also be the first RCT to evaluate the impacts of an irrigation intervention on health for any 
574 
condition including HIV. Finally, we will apply a novel theoretical framework to elucidate the 
575 
mechanisms through which improvements in food security and economic indicators may impact 
576 
HIV health outcomes. By demonstrating the role of sustainable agricultural and economic 
577 
development in improving the health of HIV-positive individuals, the proposed investigation can 
578 
have a major public health impact and has the potential to improve the ways in which 
579 
development and HIV health care services are integrated and delivered throughout rural Africa. 
580 
Our work also provides an innovative approach to address the intersections between 
581 
health, agricultural and socio-economic problems. This project brings together an 
582 
interdisciplinary team of experts in agriculture, economics, epidemiology, biostatistics, 
583 
behavioral science, HIV medicine, medical sociology, and gender studies. We will collaborate 
584 
with an HIV care and treatment program (Family AIDS Care & Education Services, or 
585 
FACES),193 an international non-governmental organization (KickStart), a Kenyan finance 
586 
organization, and the Kenyan Ministry of Health (MOH). Such collaborations are well positioned 
587 
to contribute toward sustainable public health solutions that resolve the intersecting problems of 
588 
food insecurity, poverty, and HIV/AIDS morbidity and mortality in SSA. By contributing to 
589 
dialogue among those involved in international agricultural policy and ART delivery in SSA, the 
590 
proposed study can impact both sectors, facilitating effective utilization of resources. Also, the 
591 
intervention may play an important role in improving women’s empowerment, and for child 
592 
nutrition, as suggested by observational studies conducted in Kenya194 and elsewhere.195-201  
593 
7. HYPOTHESIS 
594 
Hypothesis 1 (Aim 1):  The intervention will lead to improved viral load suppression (primary 
595 
outcome) and other measures of morbidity such as changes in CD4 cell count, physical health 
596 
status, WHO stage III/IV disease, and hospitalizations (secondary outcomes) in the intervention 
597 
arm compared to the control arm.  
598 
Hypothesis 2 (Aim 2):  The intervention will improve food security and household income, which 
599 
in turn will contribute to improved outcomes through nutritional (improved diet quality, nutritional 
600 
status), behavioral (improved ART adherence and retention in care), mental health (improved 
601 
mental health/less depression) and empowerment (gender role attitudes, household decision-
602 
making) pathways18 (Figure 2). 
603 

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8a. GENERAL OBJECTIVES 
604 
Our interdisciplinary team will conduct a randomized control trial in the Nyanza Region, 
605 
Kenya to understand whether a multisectoral agricultural and finance intervention improves HIV 
606 
clinical outcomes, and to elucidate the causal pathways (nutritional, mental health, and 
607 
behavioral) through which the intervention may lead to these outcomes. We also aim to 
608 
determine whether the intervention is cost-effective and sustainable.  
609 
8b. SPECIFIC OBJECTIVES 
610 
1. To determine the impact of a multisectoral agricultural intervention among HIV-infected 
611 
farmers on ART on HIV clinical outcomes. The primary outcomes is improved viral load 
612 
suppression secondary outcomes include changes in CD4 cell count, physical health status, 
613 
WHO stage III/IV disease, and hospitalizations. 
614 
2. To understand the pathways through which the multisectoral intervention may improve HIV 
615 
health outcomes.   We will investigate nutritional, behavioral, mental health and empowerment 
616 
pathways.  
617 
3. To determine the cost-effectiveness of the intervention and obtain the information necessary 
618 
to inform scale-up in Kenya and similar settings in SSA. We will quantify the cost per disability-
619 
adjusted life year averted, and identify lessons to inform successful scale-up. 
620 
9. STUDY DESIGN AND METHODOLOGY 
621 
Overview 
622 
We plan to conduct a matched pair cluster RCT of a multisectoral agricultural intervention 
623 
among HIV-infected farmers on ART to determine the impact of the intervention on HIV viral 
624 
load suppression (primary outcome), and additional health outcomes including changes in CD4 
625 
cell counts, WHO Stage III/IV disease, hospitalizations, physical health status and mortality 
626 
(secondary outcomes). We will also determine the impact of this intervention on mediating 
627 
outcomes in the hypothesized causal framework.  Proximal mediators include food security and 
628 
household economic indicators. We will also look at nutritional (diet quality, anthropometry), 
629 
behavioral (ART adherence, engagement and retention in care), mental health (depression, 
630 
mental health status), and empowerment (gender role attitudes, household decision-making) 
631 
mediators as per our causal framework (see Figure 2). We will randomize 8 matched pairs of 
632 
health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and 
633 
enroll up to 65 participants per health facility (total up to n=1040). All participants will be 
634 
followed for 2 years. Impacts of our intervention on primary health outcomes and mediators will 
635 
be investigated to assess direct and indirect intervention effects. Control participants will be 
636 
eligible for the intervention at the end of the 2-year follow-up period. Alongside the trial, we will 
637 
conduct a cost-effectiveness analysis and a process evaluation, which includes interviews with 
638 
study participants, staff and various stakeholders to understand strengths and pitfalls of the 
639 
intervention and translate lessons learned to guide a possible scale-up of the intervention in 
640 
similar settings in East Africa.  
641 
The Shamba Maisha intervention has three components. Shamba Maisha will be spearheaded 
642 
by UCSF and KEMRI. The agricultural components of the intervention will be led by KickStart. 
643 
The economic elements will be implemented by a Kenyan finance institution. Following our 
644 
causal framework, the intervention diagram (Figure 2) illustrates the relationship between 
645 
intervention components and hypothesized outcomes (Page 11). We hypothesize that the 3 
646 
intervention components will act synergistically to impact outcomes.   
647 
KickStart Irrigation pump: Recognizing the need for improved agricultural tools for poor farmers 
648 
in Kenya, KickStart, an international NGO, developed a low-cost irrigation pump for use by local 
649 
entrepreneurs seeking to establish small agricultural businesses. KickStart has been a leader in 
650 
irrigation technologies since 1991 through their manually operated “MoneyMaker” pumps, which 
651 
are widely available in Kenya (retail cost: ~$60). These portable, low-cost, human-powered 
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March 27, 2019 
pumps can pull water from up to 23 feet (either surface water or a shallow well) and push water 
653 
an additional 46 feet above the pump. These pumps enable farmers to irrigate larger amounts of 
654 
land, harvest more crop cycles, and plant crops with less regard for the seasonality of rainfall, 
655 
thus capitalizing on higher off-season crop prices in the marketplace. This technology has 
656 
reduced food insecurity and poverty for 800,000 users in 22 countries in the subcontinent since 
657 
1991202 Farmers using this irrigation pump enjoy up to a ten-fold increase in income.203-206 
658 
Similarly successful models of irrigation in India and Nepal have been found to improve income 
659 
and food insecurity by increasing crop yields by up to 200% and reducing water consumption by 
660 
40-70%.207 As a result of its documented success in our previous studies and local availability, 
661 
KickStart’s irrigation pump, as part of an agricultural intervention, has the potential to improve 
662 
food security, economic and health outcomes.  As described below, participants receive a 
663 
voucher for the pump at the time of receipt of their asset loan.  
664 
Agricultural training: Upon loan receipt, participants in the intervention arm will receive training 
665 
on the use of the MoneyMaker irrigation pump. Participants will also attend approximately 8 
666 
separate 3-hour training modules over the agricultural season (didactic sessions and practical 
667 
demonstrations) in sustainable farming techniques, including seed selection, soil and water 
668 
conservation, fertilization and crop rotation, integrated pest and disease management (IPM), pre 
669 
and post-handling and marketing, and identifying improved market access for selling 
670 
horticultural products. Participants will be encouraged to grow locally available and 
671 
environmentally sustainable crops, and to diversify crops to ensure a diverse diet and adequate 
672 
markets for their produce. All trainings will be delivered by agricultural trainers, will take place on 
673 
participant’s farms or a nearby location, and will occur in the context of patient support groups. 
674 
Agricultural trainers will also conduct 1-hour visits to individual farms as needed to support study 
675 
participants. We developed initial field-based trainings based on a needs assessment 
676 
conducted prior to launching the R34 pilot, and tested and refined the training course during the 
677 
pilot. Trainings were further updated based on process evaluation findings from our R34 study, 
678 
and will be tailored to the needs of farmers based on crop selection. Nearly all pilot intervention 
679 
participants found the training to be extremely useful and reported rapid improvements in 
680 
agricultural practices and yields.  
681 
Loan program and finance training: Participants will be given an asset loan (worth ~US $175) 
682 
for the purchase of the irrigation pump and other agricultural implements. The loans will be 
683 
managed by a Kenyan finance organization. In accordance with standard practice for individual 
684 
loans, and as done in our pilot study, participants will be required to save no more than 2,000 
685 
KSH (~US $20) prior to receiving the loan. These savings will be placed in a bank account at 
686 
one of the local branches. Each participant will receive the loan in the form of vouchers to 
687 
purchase the irrigation pump, 50 feet of hosing, fertilizer, and government certified seeds. These 
688 
materials will be made available at local farm stores (“agrovets”) that are easily accessible in 
689 
study communities. Loan repayment will follow the guidelines of the local MFI with payment 
690 
expected within 16 months (starting with a 4-month grace period of no payment, followed by 12 
691 
months of monthly payments). The finance organization will document the loan payments made 
692 
by each participant and will provide a quarterly financial report to the study coordinator and PIs. 
693 
The finance organization will be solely responsible for collection of loan payments, following 
694 
their usual standard protocol for participants who fail to repay their loan. Participants will not be 
695 
asked to forfeit personal belongings to cover loan payments. Those who repay their loans may 
696 
choose to take out additional loans (in accordance with standard policies), to allow for further 
697 
investment and development. Our goal is to provide an enduring relationship between 
698 
participants and the finance organization.  
699 
The intervention arm will receive training at baseline and at key intervals coordinated with 
700 
harvesting seasons on financial management, group formation and management, record 
701 
keeping, micro enterprise development, market planning and research, customer relations, 
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preparation of a business plan, and marketing skills. Trainings will be facilitated by the finance 
703 
organization in collaboration with our study team. All trainings will take place on participants’ 
704 
farms or a nearby location.  
705 
a. Study site (geographical) 
706 
Residents of Nyanza Region including our target counties (Homa Bay, Kisumu, and Migori) 
707 
have significant potential to benefit from the proposed intervention: The Nyanza Region has the 
708 
highest prevalence of HIV in Kenya (15.1%),208 and a very high prevalence of food insecurity.14 
709 
Unlike more urban environments, there are few alternatives to agricultural production for 
710 
income.209 Farming and fishing are the primary means of income generation. Lack of irrigation 
711 
and unpredictable rainfall lead to an inconsistent water supply and pose a central barrier to 
712 
successful farming for many in the region.210 Entrenched poverty and limited access to financial 
713 
services means that few farmers are able to obtain quality agricultural inputs.  
714 
Eight matched pairs of facilities will be selected for inclusion in the study. Pair matching helps 
715 
protect study credibility and validity with a limited numbers of clusters, and also can substantially 
716 
improve power.211,212 With newer matching algorithms/schemes, we can get close matches with 
717 
multiple variables predictive of the outcome.213-216 Therefore, we will match facilities on the 
718 
following criteria: 1) size of facility (district, sub-district hospital, health center, dispensary) 2) 
719 
geography defined by sub-county, 3) primary source of water for irrigation (lake, river, shallow 
720 
wells), and 4) access to markets. We will select matched pairs that limit the chance of 
721 
contamination between intervention and control health facilities based on geographic proximity 
722 
and ethnographic mapping. Based on our pilot work, the minimum requirement for health facility 
723 
inclusion in the study are: Ministry of Health facility that serves a minimum of 350 patients on 
724 
ART, proximity to permanent water source/s (river, lake, and streams), suitable soil for farming, 
725 
proximity to markets, and where farming is one of the a key economic activities in the 
726 
community (i.e.: 50% of the population is involved in agriculture as the primary means of 
727 
income, which will apply to most of the Ministry of Health facilities in Nyanza Region). 
728 
Randomization, based on a computer-generated assignment, will occur after the 8 matched 
729 
pairs have been selected.  
730 
b. Study populations 
731 
Participants will be recruited from the  Kenyan Ministry of Health (MOH) facilities. As patients in 
732 
the MOH facilities, all participants at intervention and control health facilities will receive 
733 
HIV/AIDS care and treatment, including ART, in accordance with MOH standards.  
734 
i. Criteria for inclusion of subjects 
735 
At both intervention and control health facilities, we will enroll up to 65 persons currently 
736 
enrolled in HIV care per health facility. Eligibility criteria will be similar to our pilot study.  
737 
1. HIV-infected adults  
738 
2. 18-60 years old 
739 
3. Currently receiving ART  
740 
4. Belong to a patient support group or demonstrate willingness to join one.  
741 
5. Have access to farming land and available surface water in the form of lakes, rivers, ponds 
742 
and shallow wells.  
743 
6. Have evidence of moderate to severe food insecurity based on the Household Food 
744 
Insecurity Access Scale (HFIAS), and/or malnutrition (BMI<18.5) based on medical records 
745 
during the year preceding recruitment.  
746 
7. Participants must also agree to save the down payment (no more than 2,000 KSH) required 
747 
for the loan  
748 
 
749 
These criteria are likely to be met by the majority of HIV-infected patients on ART in Nyanza 
750 
Region, as we saw in our pilot study.  
751 

Protocol Version 9.0  
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March 27, 2019 
ii. Criteria for exclusion of subjects 
752 
1. People who do not speak Dholuo, Swahili, or English 
753 
2. Inadequate cognitive and/or hearing capacity to complete planned study procedures, at 
754 
the discretion of the research assistant 
755 
c. Sampling 
756 
i. Sample size determination 
757 
Data from the Shamba Maisha pilot R34 intervention study were used to estimate the sample 
758 
size needed for this proposed study for the outcomes of changes from month 0 to month 24 in 
759 
food insecurity score (key mediating variable), CD4 count, and viral load suppression (key 
760 
outcome variable). The standard deviations (SD) seen in the proposed study likely will be similar 
761 
to that in the pilot study because the two studies draw from a similarly geographically dispersed 
762 
population. To be conservative, we assumed a coefficient of variation due to clustering of 0.150, 
763 
ignoring the matched pairs.217 Retention in the pilot study was 98%; to be conservative, 
764 
retention in the proposed study was assumed to be 90%. For two-sided testing at α=0.05 in a 
765 
longitudinal analysis, a sample of 8 health facilities per arm with up to 44 enrolled participants 
766 
per health facility (total enrollment of up to 352 per arm) will provide power of 80% for an 
767 
important clinical difference of 0.138 between the intervention and control arms in the proportion 
768 
becoming virally suppressed from month 0 to month 24 (primary outcome).217 We plan to over-
769 
enroll the number of participants by up to 65 per facility to account for participants that may not 
770 
be able to save the down payment. That is, assuming as in our pilot study that 0.150 of the 
771 
sample in the control arm becomes suppressed from baseline to month 24, there is 80% power 
772 
to detect differences such that the proportion becoming suppressed from baseline to month 24 
773 
in the intervention arm is 0.288 or greater. In regards to two secondary outcomes, the within-
774 
arm SD for changes in food insecurity score and CD4 count were estimated from the pilot study 
775 
as 2.95 and 208.9 cells/mm3, respectively. The proposed sample size will provide power of 80% 
776 
for differences of 1.2 for food insecurity (HFAIS score) and ≥57 cells/mm3 for CD4 count. 
777 
ii. Recruitment procedures  
778 
Following the procedures from our pilot intervention study, participants will be recruited through 
779 
organized meetings held at each health facility, publicized through announcements at patient 
780 
support group sessions. At each meeting, research staff will present study details and eligibility 
781 
guidelines. Among interested and potentially eligible individuals, home visits will be conducted 
782 
to verify that the participant has access to agricultural land and surface water. Individuals that 
783 
meet eligibility criteria but decline to participate in the study will be asked to discuss reasons for 
784 
declining participation. Using female recruiters and promotional material geared towards 
785 
recruiting women, we will enroll at least 40% of participants at each health facility from each 
786 
gender. At intervention health facilities, participants will be enrolled in a savings program in 
787 
anticipation of receiving the asset loan. In control health facilities, participants will be enrolled in 
788 
the intervention at the end of 2 years follow-up.  
789 
iii. Enrollment procedures 
790 
Individuals who express interest in the study will be asked to consent to screening for the study 
791 
in order to assess their eligibility.   The screening procedures will involve a brief questionnaire 
792 
(up to 10 minutes) on food security and access to farming land and surface water and a brief 
793 
review of medical records.  If they are eligible based on this information, a home visit will be 
794 
conducted to confirm access to farming land and available surface water.  If they are still eligible 
795 
for the study and continue to be interested in participating, the individual will undergo the 
796 
informed consent process for the study. Enrolled participants in the intervention arm are 
797 
required to save a down payment of no more than 2,000 KSH for the asset loan by the end of 
798 
the finance training.  Control participants must also agree to save the down payment (~$20) 
799 
required for the loan by the study end.  At each data collection point conducted at the health 
800 

Protocol Version 9.0  
19 
March 27, 2019 
clinic, participants will receive up to 800 Kenyan Shillings (~$8.40) depending on the distance 
801 
they have to travel, and at each data collection point conducted at their home or farm, they will 
802 
receive up to 400 Kenyan Shillings (~$4.20). 
803 
d. Procedures 
804 
Conduct a cluster RCT of a multisectoral agricultural intervention among HIV-infected 
805 
farmers on ART to determine the impact of the intervention on HIV clinical outcomes 
806 
After study enrollment, participants in Intervention health facilities will be immediately formed 
807 
into a patient support group of 8-14 Shamba Maisha participants for delivery of the intervention.  
808 
During the pilot study, we found that the patient support groups were a vital source of social and 
809 
emotional support and strength for study participants. The groups provided an opportunity for 
810 
sharing information, knowledge, ideas, and experiences in a confidential manner. Members also 
811 
benefited from the coping skills gained, insight into the issues affecting others, and bonds made 
812 
with others going through a similar experience. HIV positive people living positively and thriving 
813 
also serve as role models and inspiration to others, and encourage care and treatment 
814 
adherence. All agriculture and finance trainings will be conducted within the patient support 
815 
group setting so that participants can learn from and support each other and help address any 
816 
challenge that individuals may face on their farms (i.e. pest control) or in repayment of their 
817 
asset loan. Participants will also be enrolled in a savings program in anticipation of receiving the 
818 
asset loan. In control health facilities, HIV-infected patients between the ages of 18-60 receiving 
819 
ART, have access to farm land and surface water, and have demonstrated evidence of food 
820 
insecurity or malnutrition during the year preceding the study will be recruited as controls. 
821 
Control participants must also agree to save the down payment of no more than 2,000 KSH 
822 
(~$20) required for the loan by the study end. All intervention and control participants will be 
823 
reimbursed for their transportation and time up to 800 Kenyan Shillings (~$11) for data 
824 
collection that take place at the clinic and up to 400 Kenyan Shillings (~$5.5) for data collection 
825 
that takes place at home.  
826 
Data collection 
827 
The research staff will administer surveys to both arms at baseline and at 6, 12, 18, and 24 
828 
months.  Data will be collected within a window period around each data collection time point of 
829 
+/- 2 months.  For example, the six-month data collection period must take place 4 – 8 months 
830 
after enrollment. The content of these interviews will cover demographic information; household 
831 
economic indicators; detailed agricultural information; income, physical and mental health 
832 
status; food and water insecurity and dietary diversity; healthcare utilization; social support and 
833 
HIV-related stigma; ARV treatment status and adherence; intimate partner violence; risk 
834 
tolerance and entrepreneurial ability; HIV risk behavior, including sexual activity and substance 
835 
use; well-being, hope, relationship quality; and gender empowerment.    
836 
A section of the interview will be administered at the health facility (for either clinical or sensitive 
837 
information), and another section will be administered at the participant’s farm or household 
838 
(see below). At the end of the home visit, we will also dfscapture the GPS coordinates of the 
839 
home for data verification purposes.  In addition to interview data, we will also abstract clinical 
840 
data from the Comprehensive Care Clinic Patient Card, known as the blue card or green card 
841 
(every 6-months for viral loads,CD4 T-cell counts,  ART treatment interruptions and episodes of 
842 
opportunistic infections). Clinicians or trained phlebotomist will collect additional blood for viral 
843 
load and CD4 testing once per year. For those who miss their yearly blood draw , we will 
844 
conduct an additional blood draw to ensure that we have these measures twice yearly on all 
845 
participants. Phlebotomy will be performed using universal precautions, and specimens will be 
846 
aliquoted, assigned an accession number, and stored at -70 C until shipment to the laboratory 
847 
for processing. We will also perform mid upper arm circumference measurements to assess 
848 

Protocol Version 9.0  
20 
March 27, 2019 
nutritional status, body mass index measurements. Table 1 shows measures and health 
849 
outcomes following our theoretical model.  
850 
Table 1. Measures 
851 
Nutritional 
Pathway 
Nutritional status: We will use BMI and MUAC, commonly used to assess nutritional 
status.218,219 The BMI reflects protein and fat reserves220 and will be assessed using an 
established grading system.221 For MUAC, we will use WHO sex-specific cut-offs of 22.0 
cm for women and 23.0 cm for men with chronic energy deficiency.222 
Food frequency will be measured as the number of different foods or food groups 
consumed over a given period,223 as used in the Kenya Demographic and Health Survey. 
Behavioral Pathway 
ART adherence: Participants will receive a Medical Electronic Monitoring System 
(MEMS) bottle to record bottle opening events providing a graphical printout of adherence. 
MEMS is one of the most extensively validated objective measures of ART adherence for 
use of studies in SSA, is closely correlated with undetectable viral loads, 224 and has been 
found to be feasible and acceptable to patients in the Nyanza Region by our study 
team.225 226 For self-report adherence, we used the visual analog scale,227 which 
corresponds to the percentage of prescribed doses taken, and is correlated with 
unannounced pill count and MEMS.228,229,226   
Health care utilization and competing demands: We will collect data on urgent care 
visits and adherence to regular clinic visits using both self-report and abstraction of data 
from medical records comparing their scheduled visit date with their actual visit date. This 
method has used to assess clinic attendance in the literature.230,231 Questions will be 
modified from Gelberg and Anderson’s Behavioral Model for Vulnerable Populations232,233 
to assess how often lack of food interferes with ability to procure drugs or visit the clinic. 
Mental Health Pathway 
Mental health status will be measured using the MOS-HIV, a tool for assessing health-
related quality of life234 that has been validated among HIV-infected populations in 
resource-limited settings.235,236   Depression will be screened using the Hopkins Symptom 
Check-list for Depression, a 15-item scale237 which has been validated in sub-Saharan 
Africa.238 Alcohol use: We will use the AUDIT-C indicators.  The AUDIT-C is a 3-item 
alcohol screen that can help identify persons who are hazardous drinkers or have active 
alcohol use disorders.239 
Wellbeing, hope, and relationship quality.  The ‘Cantril ladder’ was developed by 
Kilpatrick and Cantril (1960) and has since been used in several cross-national studies 
including Gallup's World Poll of more than 150 countries to measure general well-being.  
The relationship quality questions were adapted from the four item Couple Satisfaction 
Scale by Funk, J.L. & Rogge, R.D (2007). 
HIV-related stigma and disclosure: We will use the Earnshaw Stigma Scale, which has 
been extensively validated in sub-Saharan African settings.We will ask about disclosure of 
HIV status to partners, family members, and others using questions adapted from our 
previous studies in SSA.101,240,241 

Protocol Version 9.0  
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March 27, 2019 
Empowerment 
Pathway 
Empowerment indicators will be adapted from a large cluster-randomized trial of an 
intervention including: greater challenges to established gender roles, communication with 
relationship partner about sexual matters, measures of financial decision-making, 
measures of attitudes towards gender roles and gender-based violence, and experience 
of controlling behavior by relationship partner.242 In addition, we will use the Sexual 
Relationship Power Scale (SRPS),243 which conceptualizes sexual relationship power as a 
multi-dimensional construct assessing relative degrees of relationship control and decision 
making dominance. The SRPS has been used successfully in observational research 
conducted in South Africa244,245 and Uganda.246 We will also collect data on sexual 
victimization and perpetration in the prior 3 months.   
Proximal Mediators 
Food insecurity: The Household Food Insecurity Access Scale (HFIAS) has been 
validated in eight countries168,247-249 and used successfully by our team in Kenya and rural 
Uganda.24,246,250-254 
Agricultural measures include questions about production, costs, harvesting and 
marketing, labor, irrigation, and post harvesting practices. Measures were designed to 
evaluate uptake and adoption of the intervention, and measure changes in agricultural 
practices including crop diversity, agricultural practices and production.    
Household economic indicators: Household economic indicators will be collected using 
a modified version of the World Bank Living Standards Measurement Study (LSMS) 
questionnaire.255 Because the economic impact of the intervention likely will differ with 
where agricultural production is directed (e.g., market, household consumption, bartering 
produce for other goods) we will measure several economic outcomes: a) expenditures 
(food, health, education, and productive investments); b) consumption (food and non-
food); c) income (from agriculture and all sources); d) savings and debt; and e) inter-
household commodity and cash transfers. We have extensively used these questionnaires 
for prior studies in Kenya including in the ongoing SEARCH trial. 
Health Outcomes 
HIV related mortality: The 2012 WHO verbal autopsy instrument will be used to 
determine cause of death.256 Information will also be gathered from the hospital 
record review and hospital discharge diagnosis. 
Viral load testing will be performed on venous blood on the COBAS TaqMan 
HIV viral load platform (Roche Molecular Diagnostics, Pleasanton, CA) with a 
lower limit of detection of <20 copies/mL. 
Absolute CD4 count testing on whole blood will use the BD FACSCount (BD 
Bioscience, San Jose, CA). 
HIV morbidity: We will abstract data on hospitalizations, opportunistic infections, and 
changes in WHO disease stage from medical records. We will also gather self-report 
data on opportunistic infections, hospitalizations and HIV symptoms during structured 
interviews.  
Physical health status will be measured using the MOS-HIV, a tool for assessing 
health-related quality of life234  that has been validated in resource-limited settings.235,236  
Covariates 
Demographics: Age, religion, education, marital/partnership status, cost/time to reach 
the health facility, number of children, and household census will be collected at 
baseline. Changes to the household census will be captured every year. 
Social support: We will adapt the Functional Social Support Scale,257 a modified version 
of the Duke University-University of North Carolina Functional Support Questionnaire258 
consisting of questions related to perceived emotional and instrumental support.  
Risk tolerance and entrepreneurial ability: We will adapt established questionnaires 
that have been used to measure individuals’ attitudes towards risk as well questionnaires 
from microfinance studies that seek to measure individuals’ entrepreneurial ability. 259,260 

Protocol Version 9.0  
22 
March 27, 2019 
Data quality and management: The Comprehensive Care Clinic Patient Card includes 
852 
detailed information on health indicators (CD4 counts, WHO staging, OIs, drugs, etc.). 
853 
Data from the blue card and those specifically conducted for this study (questionnaires, 
854 
VL measurements, MUAC, weight and height) will be entered into a handheld computer 
855 
tablet for data entry operating Open Data Kit (ODK) Collect. We successfully piloted the 
856 
use of tablets and the ODK system during the pilot study. Procedures to promote data 
857 
quality of these databases will include range and logical checks built into the data entry 
858 
program, and running a series of additional error checks on the databases after data 
859 
entry. We will investigate the patterns and types of missing data and non-response. 
860 
Initial analyses also will involve inspection of the distributions of our mediating and 
861 
outcome variables to identify outlying or unusual values and to assess distributional 
862 
characteristics. We will also assess validity of scale constructs via exploratory and 
863 
confirmatory factor analysis and perform internal consistency analyses to assess scales’ 
864 
reliabilities.  
865 
Facility Viral Load Checklist 
866 
 
867 
From the award of the PEPFAR III program in 2016- FACES now offers technical support to 
868 
Kisumu County and some of the sites are now under the Elizabeth Glazer Paediatric Foundation 
869 
(EGPAF) and the University of Maryland (UMB). 
870 
  
871 
The interpretation of the viral load results and the actual treatment changes made for 
872 
participants in our study who are patients at these health facilities is determined by those given 
873 
care at those health units.    In order to appreciate differences in how study facilities interpret 
874 
viral load data and make decisions on how to care for these patients, some of whom are our 
875 
participants – we propose to use a Viral Load Readiness Check list to assess the protocols 
876 
used at these facilities to guide their decisions making.  And how they use this information to 
877 
guide ART therapy, patient follow-up, and adherence counseling.  
878 
  
879 
This will allow us to analyze the relationship between possible disparities in viral load readiness 
880 
across sites and any disparities we observe in our primary outcome, viral load suppression at 
881 
the time of our data analysis.  This tool will be a program evaluation tool for the clinics and we 
882 
also communicate information regarding any identified weaknesses in viral load interpretation 
883 
practices to individual facilities in order to improve patient care for all facility patients.  
884 
  
885 
The study staff will conduct the viral load readiness initiative at the sixteen Shamba Maisha 
886 
study facilities in Kisumu, Homa Bay, and Migori counties. The purpose and procedures of the 
887 
assessment will be explained to administrators and clinicians at each facility by a representative 
888 
of Shamba Maisha during a face-to-face meeting prior to the assessment.  Study staff will 
889 
subsequently administer an approximately one-hour assessment at each site using the attached 
890 
Viral Load Readiness Assessment form, a version of the International Center for AIDS Care and 
891 
Treatment Program (ICAP) Viral Load Readiness assessment form’s “Clinical Care Related 
892 
Questions” section that has been adapted with input from FACES staff and clinicians for the 
893 
context of our study. The form consists of a checklist of facility practices that comprise both self-
894 
report data and data verified by visual inspection, as indicated by an asterisk. Additional notes 
895 
will be kept in the“Comments” section of each form. Assessments will be conducted with the 
896 
primary ART clinician at each site in English. Assessments will not include any individually 
897 
identifiable or personal data and will include clinic-level information only. 
898 
  
899 
Immediately after administration of the form, study staff will score the form using the scoring 
900 
template provided by ICAP. A “percentage readiness” will then be recorded on each 
901 

Protocol Version 9.0  
23 
March 27, 2019 
assessment form according to the total composite score. Results of the assessment will be used 
902 
to aid Shamba Maisha investigators in interpreting viral load data across sites.  All results will 
903 
also be disseminated to facility administrators within one month of assessment completion.  
904 
  
905 
We believe this assessment will provide us with critical information that will enhance our 
906 
analysis of the study’s primary outcome and contribute to long-term improvement of patient care 
907 
at our study facilities.  
908 
 
909 
Conduct a Process Evaluation to Inform Scale-up: We will assess implementation, feasibility 
910 
and acceptability of intervention components to inform scale up. Using mixed methods, we will 
911 
collect qualitative and quantitative data throughout the study. Staff will collect information on 
912 
training attendance and participation levels (assessed on a 1-5 scaled rubric). Participant 
913 
observation will be led by a researcher trained in ethnographic methods who will collect notes 
914 
on observed delivery of key study and intervention components, community recruitment 
915 
meetings, home visits to determine eligibility, agricultural training, business skills training and 
916 
loan repayment procedures. Weekly meetings with detailed minutes including research staff and 
917 
health care personnel will document challenges with recruitment and procedures in both the 
918 
intervention and control arms, including reactions by participants, difficulties encountered, areas 
919 
for improvement, and overall assessment of implementation. Twice monthly debriefings to 
920 
review minutes will occur with the intervention team and study investigators. Structured exit 
921 
interviews will be conducted with up to 350 intervention and up to 350 control participants to 
922 
further assess intervention acceptability to inform scale-up. We will ask for detailed feedback on 
923 
the key intervention components (microcredit loan, agricultural/finance training, use of the 
924 
irrigation pump, patient support groups), and elicit suggestions for improvement.  With control 
925 
participants, we will ask if they participated in a farming training, received a loan, or own a pump 
926 
to determine if there was study contamination.  In-depth interviews with up to 124 intervention 
927 
participants and up to 25 key informants (study coordinators, health care providers, and 
928 
representatives from partner organizations) will assess challenges and facilitators of intervention 
929 
components from the perspective of those who received and delivered the intervention. 
930 
Interview themes will include: a) participation and attendance; b) securing loans; c) agricultural 
931 
training topics, d) loan receipt and repayment; d) relationship between program participation and 
932 
clinic attendance f) sense of empowerment and gender equity among participants; and g) 
933 
perceptions of intervention efficacy based on land tenure and ownership; and h) perceptions of 
934 
climate change, the impact of climate change on farming, food security, nutrition and health, 
935 
changes participants are making to address climate change, and if Shamba Maisha is impacting 
936 
how participant’s deal with climate change.  We will also ask pregnant women and women who 
937 
were recently pregnant about the impact of Shamba Maisha on their health, antenatal care, 
938 
family planning, diet, farming, income, and relationships. To gain diverse perspectives, we will 
939 
interview both male and female participants and participants who completed the study as well 
940 
as those who dropped out. These interviews will be conducted in either D’Luo or Kiswahili, last 
941 
approximately 60 minutes and will be digitally recorded and transcribed. 
942 
 
943 
As part of intervention refinement, we will conduct open-ended interviews with up to 25 key 
944 
stakeholders to gather information to help us with adapting and improving the intervention.   Key 
945 
stakeholders to be contacted include leading experts in agriculture and finance in Kenya, 
946 
relevant government officials, and health experts.   Topics that may be covered will include: 1) 
947 
Experiences, successes and challenges with  loans, and specifically among individuals with 
948 
chronic illness; 2) strategies to maximize loan repayment while minimizing stress and any risks 
949 
to participants; 3) Recommendations for maximizing agricultural yields including seed selection, 
950 

Protocol Version 9.0  
24 
March 27, 2019 
and improving market access; 4) Experiences and suggestions on maximizing agricultural and 
951 
finance trainings, and 5) Other topics related to the implementation of the intervention. 
952 
10. ETHICAL CONSIDERATIONS 
953 
The study protocol and forms will be submitted to the UCSF Committee on Human Research, 
954 
as well as the Scientific and Ethical Review Unit (SERU) of the Kenya Medical Research 
955 
Institute (KEMRI).   
956 
Human Subjects Involvement and Characteristics:  
957 
Involvement of human subjects:   
958 
All participants will be asked to consent to screening for the study in order to assess their 
959 
eligibility. This will involve a brief questionnaire (up to 10 minutes) on food security and 
960 
availability of surface water, a brief review of medical records, and a home visit to confirm 
961 
access to surface water. 
962 
Individuals who meet eligibility criteria 1-6 (section 8.b.i) will be asked to provide informed 
963 
consent and will be enrolled to participate in the study.  We will ask these individuals to 
964 
participate in interviews, have their blood drawn by a trained phlebotomist for measurement of 
965 
HIV viral load and CD4 count, MEMS data collection, and also to have nutritional assessments 
966 
done.   
967 
Participants will be asked to provide written informed consent for the following procedures for 
968 
the 2 year study: a) Participation in the agriculture and finance training and the loan program, in 
969 
order to purchase the Kickstart irrigation pump and other farm commodities, b) collection of data 
970 
through clinic at baseline and 6-month intervals; c) collection of agricultural and economic data 
971 
at baseline and approximately 5-7 times over the two year period; d) measurement of MUAC, 
972 
height, and weight to assess their nutritional status at baseline and 6 month-intervals; e) MEMS 
973 
data collection to measure ART adherence; f) collection of blood for testing of HIV viral load and 
974 
CD4 count at baseline and 6 month intervals (note that the MoH program includes annual VL 
975 
and CD4 testing, which the study will supplement with additional testing to ensure every 6-
976 
month VL and CD4 testing); and  f) data abstraction from their medical records g) take and use 
977 
photographs of them and their farms . Potentially vulnerable populations likely to be included in 
978 
this study are those with limited household incomes, HIV and food insecurity. Our study staff 
979 
and personnel are well-trained and experienced in working in a respectful, fair, and non-
980 
coercive manner with these populations. All study investigators and staff members with 
981 
participant contact will have completed training on the protection of human subjects.  
982 
The lead investigators at the University of California, San Francisco (UCSF) and the Kenya 
983 
Medical Research Institute (KEMRI) are well-respected research scientists who are experienced 
984 
in human subjects research and trained in excellent clinical and/or laboratory practices.  Drs. 
985 
Cohen, Weiser, and Bukusi, with guidance from the co-investigators, will be responsible for 
986 
seeking and maintaining the required IRB approvals.  
987 
j. Study enrollment:   
988 
 
989 
Criteria for inclusion of subjects 
990 
1. HIV-infected  
991 
2. 18-60 years old 
992 
3. Currently receiving ART   
993 
4. Belong to a patient support group or demonstrate willingness to join a support group.  
994 
5. Have access to farming land and available surface water 
995 

Protocol Version 9.0  
25 
March 27, 2019 
6. Have evidence of food insecurity based on the Household Food Insecurity Access Scale 
996 
(HFIAS), and/or malnutrition (BMI<18.5) based on medical records during the year 
997 
preceding recruitment 
998 
7. Potential participants must also agree to save the down payment (no more than 2,000 
999 
KSH) required for the loan.  
1000 
 
1001 
Criteria for exclusion of subjects 
1002 
1. People who do not speak Dholuo, Swahili, or English 
1003 
2. Inadequate cognitive and/or hearing capacity to complete planned study procedures, at 
1004 
the discretion of the research assistant 
1005 
 
1006 
Recruitment procedures 
1007 
Recruitment and retention plan: HIV-infected adult (18-60 years old) patients receiving ART 
1008 
will be recruited from the Ministry of Health (MoH) facilities. All participants at intervention and 
1009 
control health facilities will receive HIV/AIDS care and treatment, including ARV medications, in 
1010 
accordance with MoH standards.  
1011 
A research staff person will approach eligible subjects selected for recruitment to introduce the 
1012 
study and gauge potential subjects’ interest.  Relevant study staff will be fluent in the local 
1013 
dialect to obviate the need for translators and, as such, optimize confidentiality. The study site 
1014 
has prior experience in obtaining informed consent for research and clinical trials within the 
1015 
cultural context of Kenya, and specifically among HIV-infected individuals. The informed 
1016 
consent procedure for this study has been designed to maximize understanding of potential 
1017 
risks. All consent forms will be translated into the local languages (Dholuo and Kiswahili) and 
1018 
back-translated into English to ensure correct use of language. Consent forms will be 
1019 
summarized aloud to participants by study interviewers. Potential participants will be informed 
1020 
of: (1) the purpose and methods of the study, (2) procedures to protect their confidentiality, (3) 
1021 
their rights to withdraw from the study at any time, (4) the fact that their participation or non-
1022 
participation will not affect the care and services they receive at the Ministry of Health facility, 
1023 
and (5) persons to contact if they have any questions about the study after the completion of the 
1024 
interview, or to report any adverse events associated with study participation. Prior to seeking a 
1025 
signature, interviewers will ask participants to summarize the study and explain the reasons why 
1026 
they want to participate to the interviewers. The participant will also be given a copy of the 
1027 
consent form written in the local language to keep. The consent form will include names and 
1028 
phone numbers of persons to contact with any questions regarding the study. During the 
1029 
consent process, any misunderstandings regarding procedures, risks, or benefits can be 
1030 
clarified. Individuals will be provided with information on how to contact the study staff to report 
1031 
adverse events associated with study participation. Study staff will be trained extensively on 
1032 
how to assure that individuals provide voluntary informed consent. If a woman wishes to obtain 
1033 
the assent of her husband, father or chief, such assent may not substitute for her informed and 
1034 
voluntary consent. Individuals who cannot write will be invited to mark consent forms with a 
1035 
thumbprint (a standard practice for KEMRI clinical research), along with a co-signature by a 
1036 
witness otherwise not affiliated with the study. Each participant’s signed informed consent form 
1037 
will be kept on file by the investigators for possible inspection by regulatory authorities. 
1038 
Study retention will be monitored monthly by the research team.  We plan to implement several 
1039 
proactive retention strategies successfully used during our pilot study and in our other studies in 
1040 
the region. These strategies include obtaining extensive contact information, building 
1041 
relationships with participants, calling participants to remind them of their up-coming study 
1042 
appointments, and field outreach to participant’s homes. Participants will receive a copy of the 
1043 
scheduled visits to take home. If a participant misses his/her 6-monthly visit, a research 
1044 
assistant will make an attempt to communicate by phone, or when necessary will make a 
1045 

Protocol Version 9.0  
26 
March 27, 2019 
“home” visit to the participant’s previously agreed upon location (e.g. home, work, market, etc.).  
1046 
Research assistants will receive extensive training on procedures required for making “home” 
1047 
visits to maintain confidentiality and reduce the risk of inadvertent disclosure of the participant’s 
1048 
HIV serostatus, other confidential information, and study participation to others.   
1049 
Provision of HIV care and treatment will not be contingent upon participation in research, and 
1050 
participants will continue to receive standard of care at the same clinic should they decline 
1051 
enrollment or choose to leave the study at any point in time. 
1052 
 
1053 
Enrollment procedures 
1054 
At both intervention and control health facilities, we will enroll up to 65 persons currently 
1055 
enrolled in HIV care. Participants will be recruited through discussions about the study in the 
1056 
clinic patient waiting areas, and through organized meetings held at each health facility, 
1057 
publicized through posters and announcements at patient support group sessions. At each 
1058 
meeting, research staff, will present study details and eligibility guidelines. Among interested 
1059 
and potentially eligible individuals, home visits will be conducted to verify that the participant has 
1060 
access to farming land and surface water. Individuals that meet eligibility criteria, but decline to 
1061 
participate in the study, will be asked to discuss their reasons for declining participation. 
1062 
Through utilizing female recruiters and promotional material geared towards recruiting women, 
1063 
the study will plan to enroll at least 40% of participants at each health facility from each gender 
1064 
(which would include at least 18 women/men at each of the intervention health facilities and 18 
1065 
women/men at each of the control health facilities). This will enable us to obtain data on whether 
1066 
the effects of our intervention on health outcomes differ by gender. 
1067 
Collaborating Institutions  
1068 
Much of the on-site research will be carried out in collaboration with the Centre for Microbiology 
1069 
Research at the Kenya Medical Research Institute (KEMRI).  KEMRI will comply with all 
1070 
pertinent U.S. federal regulations and policies. Dr. Bukusi, as the local site Principal 
1071 
Investigator, serves an integral role in this proposal, as she will take responsibility for the 
1072 
scientific conduct of this project in Kenya. Specifically, she will supervise the implementation of 
1073 
this protocol, oversee the clinical and laboratory procedures, and be available as the primary 
1074 
point of contact in Kenya.  She will represent the study to local regulatory and oversight 
1075 
agencies, and KEMRI. As Chief Research Officer at KEMRI, Dr. Bukusi will work closely with 
1076 
Drs. Weiser and Cohen to oversee the program’s operations and ensure that all activities are 
1077 
within KEMRI and national Kenyan guidelines and policies.  Kickstart will lead the agricultural 
1078 
components of the intervention.  Kickstart is a prominent non-governmental organization (NGO) 
1079 
based in sub-Saharan Africa. It has been a leader in irrigation technologies since 1991 through 
1080 
the development and sales of a manually operated “MoneyMaker” irrigation pump, enabling 
1081 
farmers to grow high yield crops year-round. We have been collaborating with them since 2008. 
1082 
The economic elements of the intervention will be implemented by a Kenyan finance institution.  
1083 
Drs. Weiser and Cohen as the study PIs will be responsible for registering and providing 
1084 
updated information about the clinical trial on ClinicalTrials.gov. 
1085 
Sources of Materials 
1086 
Structured and unstructured interviews: Quantitative data in the form of structured 
1087 
interviews and laboratory tests will be collected by trained research staff.  Surveys will collect 
1088 
data on sociodemographics, food security and nutritional status, women’s empowerment, health 
1089 
status, and measures along the nutritional, behavioral, and mental health pathways (see table 1, 
1090 
page 19-20).   All of the proposed measures were used during the pilot study with the exception 
1091 
of the Medical Electronic Monitoring System (MEMS) caps, water insecurity, Intimate Partner 
1092 

Protocol Version 9.0  
27 
March 27, 2019 
violence, Risk tolerance and entrepreneurial ability, and a verbal autopsy instrument.  During 
1093 
our pilot study, we used an unannounced pill count and the visual analogue scale to measure 
1094 
ART adherence. However, based on some challenges conducting pill counts in this setting due 
1095 
to inconsistent dispensing practices by pharmacy staff and based on recent literature, we have 
1096 
chosen to use MEMS caps as our objective adherence measure. MEMS is one of the most 
1097 
extensively validated objective measures of ART adherence for use of studies in SSA, is closely 
1098 
correlated with undetectable viral loads,224 and has been found to be feasible and acceptable to 
1099 
patients in the Nyanza region by our study team.225,226 Qualitative data, including in-depth 
1100 
interviews and participant observation, will be collected by researchers trained in qualitative 
1101 
research methods.  Interviews will be done with up to 5124 intervention participants and 10 key 
1102 
informants at study exit and will include questions about reasons for program adherence or non-
1103 
adherence, positive and negative experiences with the intervention, suggestions for future 
1104 
implementation, sense of empowerment, capabilities and knowledge in the agricultural domain, 
1105 
impacts of the intervention on household decision-making, and perception of women in the 
1106 
family/community, and perceptions of climate change and the impact on farming, food security, 
1107 
nutrition and health.  We hope to understand if Shamba Miasha mitigates the negative impacts 
1108 
of climate change on food security, nutrition, and health.  We will also ask pregnant women and 
1109 
women who were recently pregnant about the impact of Shamba Maisha on their health, 
1110 
antenatal care, family planning, diet, farming, income, and relationships. The qualitative study 
1111 
will utilize a semi-structured guide which will be adapted, with additional probes and questions 
1112 
added, depending on needs and emergent data. The sample IDI guide, however, captures all 
1113 
the topics that will be explored during the interview. All in-depth interviews will be conducted in a 
1114 
private room designated for this purpose at the study health facilities or a nearby location. 
1115 
Audio-recordings, transcripts, and forms will be stored in a locked cabinet at the research office 
1116 
and on password protected computers only accessible by members of the research team. 
1117 
Home visits will be conducted prior to enrolling in the research study and will be required to 
1118 
assess study eligibility. These visits will ascertain information on participant eligibility for study 
1119 
enrollment including access to agricultural land and a year-round water source. As mentioned 
1120 
above, the research assistants will be trained on the importance of confidentiality to avoid 
1121 
disclosure of a participants HIV serostatus and/or study participation.  The “home” visits can 
1122 
either take place at home, or at another previously agreed upon location. Thus, any subject who 
1123 
is concerned about a potential breach of confidentiality related to a home visit can decline the 
1124 
home visit and select instead one of several alternatives, each of which avoids potential 
1125 
disclosure to family members or neighbors. We plan to use procedures similar to those we have 
1126 
successfully used in ongoing and past projects in Kenya, Uganda and San Francisco, in which 
1127 
some subjects have elected to meet the home visitor at our research site at the Ministry of 
1128 
Health clinic, or some other site of the subject’s choosing.  Because home visiting is perceived 
1129 
as the most convenient method of contact, none of the participants in the pilot study declined 
1130 
them. If we have participants decline home visit, the clinic or an alternative location can be 
1131 
utilized. 
1132 
Community health workers in Kenya have experience conducting home visits for a 
1133 
variety of conditions in addition to HIV, including maternal child health, malaria, tuberculosis, 
1134 
malnutrition, and diarrheal diseases. As such, conducting a home visit by a research assistant 
1135 
itself is not associated with HIV infection in the target communities. Nonetheless, confidentiality 
1136 
is their primary concern.  We believe that a careful description the home visits during informed 
1137 
consent, the option to decline home visits at any time during follow-up, the convenience from 
1138 
the participant's perspective, and the low-impact of home visits themselves justifies their 
1139 
inclusion in this study. 
1140 
Data from medical record: The Comprehensive Care Clinic Patient Card is filled out by health 
1141 
workers and will be entered into tablet computers on a regular basis by the Research 
1142 

Protocol Version 9.0  
28 
March 27, 2019 
Assistants. Data will be entered on tablets operating Open Data Kit (ODK) Collect. We 
1143 
successfully piloted the use of tablets and the ODK system during the previous NIH-funded R34 
1144 
pilot study. The medical record dataset will include detailed information on health indicators (ex: 
1145 
CD4 T-cell count, WHO staging, opportunistic infections, ARV drugs). 
1146 
Data management and security: 
1147 
These data will be subjected to a variety of quality control procedures. Data collected for this 
1148 
study (questionnaires, HIV viral load (VL) measurements, height, weight, MUAC) will be entered 
1149 
into the tablet computer operating ODK system adapted from the R34 pilot study. Procedures to 
1150 
promote data quality within these databases will include range and logical checks built into the 
1151 
data entry program, and running a series of additional error checks on the databases after data 
1152 
entry.  The database will be protected by a separate password on password-protected tablets. 
1153 
Data from the tablets will be uploaded twice a week to a server located at UCSF.  All Research 
1154 
Assistants will receive training on the requirements of strict confidentiality regarding patient 
1155 
identifying information, and security regarding tablet computers.  
1156 
Study record keeping and access to participant identifying information will follow strict, written 
1157 
standard operating procedures. All records will be kept on password protected tablet computers 
1158 
at KEMRI and UCSF. Primarily, participants will be identified by their study number and/or their 
1159 
patient ID number. All participant record forms will be kept in individual files in a secured filing 
1160 
cabinet in an access-limited room at the health facility. Additional records will be kept in the 
1161 
clinical and laboratory record books, which will be stored in the local study laboratory.  
1162 
Participant names and addresses will be stripped from the database prior to analysis.  No 
1163 
individual identifying information will be used in any reports or publications resulting from the 
1164 
study. 
1165 
Potential Risks:   
1166 
The primary risks associated with the study are loss of confidentiality and risks to reputation. 
1167 
There may also be risks associated with phlebotomy to obtain the additional VL specimens, 
1168 
including pain and/or bruising. There is also the risk of fatigue from interviewing. In addition, 
1169 
participants will be asked some sensitive questions regarding sexual practices and symptoms of 
1170 
depression, which may lead to personal discomfort or embarrassment.  Finally, participants may 
1171 
experience discomfort in the case that they cannot make loan repayments. Research personnel 
1172 
are trained in strategies designed to minimize these risks and their potential impact on subjects’.  
1173 
All serious and unexpected adverse events will be reported to the Study PIs and to the relevant 
1174 
IRBs per local regulation.  
1175 
Recruitment and informed consent 
1176 
Research will be conducted according to Good Clinical Practice guidelines, the U.S. Code of 
1177 
Federal Regulations (CFR) Title 21 CFR (Part 50 – Protection of Human Subjects and Part 56 – 
1178 
Institutional Review Boards), and the Declaration of Helsinki. This protocol will be submitted to 
1179 
UCSF‘s Committee on Human Research for approval. The informed consent of each participant 
1180 
will be obtained before protocol-specified procedures are carried out.  
1181 
Participants will be asked to provide written informed consent for the following 
1182 
procedures for the 2 year study: a) Participation in the agriculture and finance training and the 
1183 
loan program, in order to purchase the Kickstart irrigation pump and other farm commodities, b) 
1184 
collection of data through clinic at baseline and 6-month intervals; c) collection of agricultural 
1185 
and economic data at baseline and approximately 5-7 times over the two year period; d) 
1186 
measurement of MUAC, height, and weight to assess their nutritional status at baseline and 6 
1187 
month-intervals; e) MEMS data collection to measure ART adherence; f) collection of blood for 
1188 
testing of HIV viral load and CD4 count at baseline and 6 month intervals (note that the MoH 
1189 

Protocol Version 9.0  
29 
March 27, 2019 
program includes annual VL and CD4 testing, which the study will supplement with additional 
1190 
testing to ensure every 6-month VL and CD4 testing); and  g) data abstraction from their 
1191 
medical records. Potentially vulnerable populations likely to be included in this study are those 
1192 
with limited household incomes, HIV and food insecurity. Our study staff and personnel are well-
1193 
trained and experienced in working in a respectful, fair, and non-coercive manner with these 
1194 
populations. All study investigators and staff members with participant contact will have 
1195 
completed NIH-required training on the protection of human subjects. The lead investigators at 
1196 
UCSF and KEMRI are well-respected research scientists who are experienced in human 
1197 
subjects research and trained in excellent clinical and/or laboratory practices. 
1198 
 
A research staff person will approach eligible subjects selected for recruitment to 
1199 
introduce the study and gauge potential subjects’ interest.  Relevant study staff will be fluent in 
1200 
the local dialect to obviate the need for translators and, as such, optimize confidentiality. The 
1201 
study site has prior experience in obtaining informed consent for research and clinical trials 
1202 
within the cultural context of Kenya, and specifically among HIV-infected individuals. The 
1203 
informed consent procedure for this study has been designed to maximize understanding of 
1204 
potential risks. All consent forms will be translated into the local languages (Dholuo and 
1205 
Kiswahili) and back-translated into English to ensure correct use of language. Consent forms 
1206 
will be summarized aloud to participants by study interviewers. Potential participants will be 
1207 
informed of: (1) the purpose and methods of the study, (2) procedures to protect their 
1208 
confidentiality, (3) their rights to withdraw from the study at any time, (4) the fact that their 
1209 
participation or non-participation will not affect the care and services they receive at Ministry of 
1210 
Health Facility, and (5) persons to contact if they have any questions about the study after the 
1211 
completion of the interview, or to report any adverse events associated with study participation. 
1212 
Prior to seeking a signature, interviewers will ask participants to summarize the study and 
1213 
explain the reasons why they want to participate to the interviewers. The participant will also be 
1214 
given a copy of the consent form written in the local language to keep. The consent form will 
1215 
include names and phone numbers of persons to contact with any questions regarding the 
1216 
study. During the consent process, any misunderstandings regarding procedures, risks, or 
1217 
benefits can be clarified. Individuals will be provided with information on how to contact the 
1218 
study staff to report adverse events associated with study participation. Study staff will be 
1219 
trained extensively on how to assure that individuals provide voluntary informed consent. If a 
1220 
woman wishes to obtain the assent of her husband, father or chief, such assent may not 
1221 
substitute for her informed and voluntary consent. Individuals who cannot write will be invited to 
1222 
mark consent forms with a thumbprint (a standard practice for KEMRI clinical research), along 
1223 
with a co-signature by a witness otherwise not affiliated with the study. Each participant’s signed 
1224 
informed consent form will be kept on file by the investigators for possible inspection by 
1225 
regulatory authorities. Participants will also be asked to give consent for photography. 
1226 
Protection against Risk:   
1227 
Planned procedures for protecting against fatigue: Baseline and follow-up interviews will 
1228 
last 1-2 hours, including phlebotomy and weight, height, and MUAC measurements. Participants 
1229 
will be informed that they can take a break or stop at any time. Staff will be well-trained and 
1230 
supervised under the direction of experienced clinical researchers. 
1231 
Planned procedures for protection of confidentiality or risks to reputation: To ensure 
1232 
confidentiality of participation, all data will be coded by a unique participant identifier number. 
1233 
Data will be kept in locked cabinets and will only be provided to a subject’s clinician upon the 
1234 
written request of the subject. Research records will be kept confidential to the level allowed by 
1235 
law. The participant’s name or other public identifiers will not be included with laboratory data, 
1236 
which will be identified only by a code number. For interview data collected as part of the study, 
1237 
subjects will be assigned a unique study identification number. Interviewers and support staff 
1238 
will be trained on procedures for maintaining privacy and will sign a pledge of confidentiality. All 
1239 

Protocol Version 9.0  
30 
March 27, 2019 
transcripts and computer records will be password-protected to prohibit illicit access.  All 
1240 
personal identifiers will be removed from any paper or electronic study forms, which will be 
1241 
coded only by numerical identifiers. When these procedures are followed, it is highly unlikely 
1242 
that any information revealed by participants during the course of the interviews or clinic visits 
1243 
will be disclosed to anyone outside the research team. 
1244 
Planned procedure for protection of risks due to phlebotomy: Phlebotomists will be well-
1245 
trained and experienced in the collection and handling of biological specimens.  To minimize 
1246 
risks due to phlebotomy phlebotomists will collect all specimens using standard sterile 
1247 
procedures. This may cause momentary discomfort or soreness when blood is drawn as well as 
1248 
minimal bruising.  
1249 
Planned procedure for protection of risks due to sensitive questions: Efforts will be made 
1250 
to minimize discomfort by assuring that interviewers are well trained and that they will inform 
1251 
participants beforehand about the nature of the questions and assure participants of privacy. 
1252 
The interviewer will be available after the interview to debrief the participant if s/he is in any way 
1253 
concerned by the nature of the questions. Routine demographic questions will be asked first, 
1254 
followed by more personal questions. Participants will be informed that they have the right to 
1255 
decline participation in the study, to refuse to answer any questions, or to withdraw at any time 
1256 
without adverse consequences. Since the Ministry of Health provides comprehensive AIDS 
1257 
education, counseling, and services, it will be possible for the interviewers to provide immediate 
1258 
referrals for research participants who are in emotional distress or exhibit any concerning 
1259 
physical signs or symptoms. As we will screen for depression, for participants who have suicidal 
1260 
thoughts, we will ask participants to speak with one of our study health providers who can 
1261 
further screen them for suicidal ideation. This may lead to some discomfort, but we hope will 
1262 
provide benefits for the participants if they are able to get access to appropriate mental health 
1263 
care. 
1264 
Planned procedure for protection of risks due to loan defaults:  Participants who fail to 
1265 
make loan repayments will under no circumstances be asked to forfeit personal or household 
1266 
belongings, other than the MoneyMaker irrigation pump, in order to repay the loans.  
1267 
Participants will also be assured that failure to repay the loans will in no way affect their access 
1268 
to medical care as well as any other benefits afforded by Ministry of Health facilities. 
1269 
Planned procedure for reporting of adverse events: All serious adverse events associated 
1270 
with the procedures of this study will be reported within 10 days to the appropriate IRBs. Current 
1271 
guidance on adverse event reporting has focused on clinical trials of drugs or devices and has 
1272 
not provided clear guidance on behavioral prevention trials. The primary risk to subjects in this 
1273 
study is loss of confidentiality. If serious or unexpected adverse events occur, these will be filed 
1274 
with the appropriate IRBs within ten working days. We will ask study participants to return to the 
1275 
research field site in the case of ongoing adverse events. We will also provide participants with 
1276 
a palm card containing information on how to contact the local field staff to report such incidents 
1277 
as HIV-related disruption of families, acts of discrimination, physical harm, adverse events 
1278 
following phlebotomy, or personal distress. Field staff will be trained to complete descriptions of 
1279 
adverse events that will then be sent electronically to the study PIs.  
1280 
Potential benefits of the proposed research to the subjects and others 
1281 
 
1282 
Participants in the intervention group will receive basic training in sustainable farming 
1283 
techniques, including education about crop varieties that grow well in the area, pest control, 
1284 
fertilization and crop rotation, as well as improved market access for selling horticultural 
1285 
products. Participants in the intervention group will also receive a microcredit loan, a human-
1286 
powered water pump, and other farming implements.  This multisectoral agricultural and finance 
1287 
intervention has many potential benefits as evidenced in our pilot study and is likely to lead to 
1288 
increased agricultural output, which will in turn may contribute to increased household wealth 
1289 

Protocol Version 9.0  
31 
March 27, 2019 
and improved food security for study participants. We also anticipate that improvements in 
1290 
household wealth and food security may in turn contribute to improved health benefits including 
1291 
improved ART adherence, mental health, nutritional status, clinical HIV treatment outcomes and 
1292 
decreased morbidity and mortality.  Finally, the intervention may lead to improved gender 
1293 
empowerment for women.  In addition to directly benefiting study participants, the proposed 
1294 
intervention has the potential to improve food security, nutrition and health outcomes of other 
1295 
family members. Control participants will be able to benefit from all aspects of intervention at the 
1296 
end of the 2-year pilot study when they will be eligible for the loan, water pump, agricultural 
1297 
implements and training. Ministry of Health facilities provide annual viral load and CD4 test 
1298 
results.  Subjects and their clinicians in both the intervention and control group will be able to 
1299 
access an additional annual viral load result and CD4 count results in the study; thus, study 
1300 
participants will undergo twice per year VL and CD4 testing.  The research findings have the 
1301 
potential to ultimately benefit other individuals in Kenya and elsewhere is sub-Saharan Africa 
1302 
who are struggling with the overlapping epidemics of food insecurity, poverty and HIV/AIDS. In 
1303 
view of the minimal risks to subjects, and the many actual and anticipated potential benefits to 
1304 
research subjects and others in their community, we believe that the benefits strongly outweigh 
1305 
the risks.  
1306 
 
The qualitative research will not provide any direct benefits to the participants, other than 
1307 
possible psychological benefits associated with sharing their insights and stories. All participants 
1308 
making clinic-based research visits during the study will receive up to 800 Kenyan Shillings 
1309 
(equivalent to ~$11) and participants will receive up to 400 Kenyan Shillings (equivalent to 
1310 
~$5.5) for home-based research visits.  
1311 
Practitioners and policy makers need replicable models with which to tackle complex health and 
1312 
social challenges such as food insecurity and HIV/AIDS. Definitive trials, along with process 
1313 
measures, can offer conclusive lessons for what works in multisectoral development 
1314 
interventions.  
1315 
 
1316 
Data and Safety Monitoring Plan 
1317 
Primary responsibility for data and safety monitoring will fall on the PIs (Drs. Weiser, Cohen and 
1318 
Bukusi). In this research, the primary risk to subjects is social harm due to loss of confidentiality 
1319 
– disruption of family (e.g., breakup of couples following HIV detection), discrimination (e.g., a 
1320 
loss of employment or status in community), physical harm (e.g., acts of physical violence 
1321 
directed at people who have been disclosed as HIV-infected) and embarrassment (e.g., being 
1322 
questioned about sexual behavior). Risks to participants will be minimized through informed 
1323 
consent and strict confidentiality. In the case of any serious adverse events, we will ask subjects 
1324 
to return to the research field site. We will also provide subjects with an informed consent 
1325 
translated into the local language of their choice, so that they have the opportunity to contact the 
1326 
local field staff or one of the study investigators at any time. Study staff will be trained to 
1327 
complete descriptions of adverse events that will be sent electronically to the principal 
1328 
investigators (Drs. Weiser, Cohen and Bukusi).  Serious or unexpected AEs will be reported to 
1329 
the appropriate IRBs within 10 working days of awareness of the incident.   
1330 
11. DATA MANAGEMENT 
1331 
a. Data Storage 
1332 
These data will be subjected to a variety of quality control procedures. Data collected for this 
1333 
study (questionnaires, HIV viral load (VL) measurements, height, weight, MUAC) will be entered 
1334 
into the tablet computer operating ODK system adapted from the R34 pilot study.  Data will be 
1335 
uploaded to a secure server. 
1336 
 
1337 

Protocol Version 9.0  
32 
March 27, 2019 
b.  Data Management 
1338 
Data quality and management: 
1339 
Procedures to promote data quality within these databases will include range and logical checks 
1340 
built into the data entry program, and running a series of additional error checks on the 
1341 
databases after data entry.  The database will be protected by a separate password on 
1342 
password-protected tablets. Data from the tablets will be uploaded twice a week to a server 
1343 
located at UCSF.  All Research Assistants will receive training on the requirements of strict 
1344 
confidentiality regarding patient identifying information, and security regarding tablet computers.  
1345 
Study record keeping and access to participant identifying information will follow strict, written 
1346 
standard operating procedures. All records will be kept on password protected tablet computers 
1347 
at KEMRI and UCSF. Primarily, participants will be identified by their study number and/or their 
1348 
patient ID number. All participant record forms will be kept in individual files in a secured filing 
1349 
cabinet in an access-limited room at the health facility. Additional records will be kept in the 
1350 
clinical and laboratory record books, which will be stored in the local study laboratory.  
1351 
Participant names and addresses will be stripped from the database prior to analysis.  No 
1352 
individual identifying information will be used in any reports or publications resulting from the 
1353 
study. 
1354 
Data analysis  
1355 
(Aims 1 and 2): Analysis of baseline data: We will describe the baseline characteristics of 
1356 
enrolled participants using frequency tables and provide descriptive statistics (e.g. means, 
1357 
standard deviations, medians, inter-quartile ranges, proportions) for scales and counts 
1358 
measuring the primary outcomes stratified by the intervention and control arms and by gender. 
1359 
From our pilot study, we expect missing data to be rare.  Values for missing scale items will be 
1360 
imputed from other scale items using regression methods.  If necessary, multiple imputation will 
1361 
be used to address incomplete data, with the mild assumption that missing data arise from a 
1362 
conditionally missing-at-random process.261 Randomization should yield equivalence between 
1363 
arms on covariates, but if non-equivalence is found on baseline measures or from differential 
1364 
attrition, we will control for it using a propensity score.262  Aim 1: Hypothesis 1:  The intervention 
1365 
will lead to improved viral load suppression (primary outcome) and other measures of morbidity 
1366 
(secondary outcomes) in the intervention arm compared to the control arm. Intent-to-treat 
1367 
analyses using Stata procedures will assess whether the intervention will result in improved 
1368 
changes in primary outcomes with mixed (i.e., fixed and random) effects, maximum likelihood 
1369 
models that use all of the longitudinal data and account for variability among clusters and 
1370 
individuals (and for pair matching of facilities if there is sufficient observed variability among 
1371 
pairs to warrant it).217,262 Aim 2:  Hypothesis 2:  The intervention will improve food security and 
1372 
household income, which in turn will contribute to improved outcomes through nutritional 
1373 
(improved diet quality, nutritional status), behavioral (improved ART adherence and retention in 
1374 
care), mental health (improved mental health/less depression) and empowerment (gender role 
1375 
attitudes, household decision-making) pathways18 (Figure 2). We will assess direct and indirect 
1376 
intervention effects using structural equation modeling to examine pathways from the 
1377 
intervention through baseline-to-endline changes in mediating outcomes to changes in primary 
1378 
health outcomes.263 264  Statistical mediation will be assessed in Mplus using the causal 
1379 
inference approach of Valeri and Vanderweele,265 which yields optimal estimates of indirect 
1380 
effects in the presence of non-continuous outcomes, interactions, and clustered data. 
1381 
Aim 3: 
1382 
Cost-effectiveness analysis: Our intervention has potential to be sustainable because it relies 
1383 
on lending and repayment rather than cash transfers. Our cost-effectiveness assessment will 
1384 
have four major components: intervention cost; net cost; health effects; and the cost-
1385 

Protocol Version 9.0  
33 
March 27, 2019 
effectiveness ratio. We will measure intervention cost per participant including recruitment, 
1386 
training, support, and loan administration and monitoring (pumps and other commodities will be 
1387 
purchased by participants, thus not a direct program cost). Loans and their repayment will be 
1388 
tracked. We will measure costs using program expenditure records, explained as necessary by 
1389 
the program manager, and focused “time and motion” studies to allocate staff time across tasks 
1390 
within and outside the intervention. Costs will be classified by program activity and by standard 
1391 
resource categories (e.g., personnel, supplies, services). Costs will also be classified as 
1392 
experienced by the program (e.g., recruitment and training) and by partners (e.g., finance 
1393 
agency) that operate without program subsidy. Donated and subsidized resources will be 
1394 
appraised at market value. Because program implementation is standard across health facilities 
1395 
and centrally managed, cost data collection will be efficient. We will next quantify net costs – 
1396 
program costs adjusted for added or averted health care costs. We will base changes in short-
1397 
term health care costs on household surveys (household expenditures for health care for illness 
1398 
episode and hospitalizations). Longer-term health care costs will be projected using clinical 
1399 
simulation modeling, based on observed changes in health status (e.g. HIV morbidity), 
1400 
combined with estimates from the trial and published studies of the costs of managing these 
1401 
conditions. Projections of HIV health care costs are imprecise but essential for a full cost 
1402 
portrayal. Uncertainty in this measure will be explored with sensitivity analyses. Health effects 
1403 
will be quantified in two ways. First, we will inventory major health-related events (deaths, 
1404 
detectable viral loads, hospitalizations, and opportunistic infections). Second, and following best 
1405 
practices in CEA, we will integrate the health impact of averted adverse events using disability-
1406 
adjusted life years (DALYs), including lost years of life and the collective disability effects of all 
1407 
the adverse events. DALY estimates will be for the short term (during the trial) and the long term 
1408 
(5, 10, and 20 years) using the clinical modeling. Finally, we will calculate cost-effectiveness 
1409 
ratios: 1) net cost per death averted (if a significant difference is observed by study arm) and 
1410 
per major adverse health event averted and 2) net cost per DALY averted. Projected health and 
1411 
financial effects will be discounted at 3% per year. We will conduct extensive sensitivity 
1412 
analyses on these ratios. Importantly, if the intervention yields net savings (i.e., negative net 
1413 
costs) as well as health benefits, the intervention is classified as “dominant” and no CE ratio is 
1414 
calculated. 
1415 
Identification of individuals most likely to benefit from the intervention: We will undertake 
1416 
regression analyses to provide guidance on targeting of finance interventions to subpopulations 
1417 
most likely to benefit. The benefits of microfinance are realized to a greater degree by 
1418 
individuals with entrepreneurial ability and risk-taking preferences, compared to individuals who 
1419 
use microfinance loans primarily for day-to-day expenses.266,267 To learn which participants were 
1420 
most likely to benefit, we will use data collected at the time of enrollment to test for 
1421 
heterogeneous effects of the intervention on health outcomes, using interaction terms with 
1422 
individual characteristics including age, gender, baseline socio-economic status, household 
1423 
status, and novel measures of risk preferences259 and entrepreneurial ability.260 
1424 
Analysis of process evaluation data. Qualitative data will be translated from local languages 
1425 
to English and imported and managed using QSR Nvivo (QSR International Ltd, Doncaster, 
1426 
Australia).  A start list of broad codes will be informed by Bonell’s process evaluation 
1427 
framework,268 with two researchers coding the transcripts in an effort to identify broad themes.269 
1428 
Transcripts will then be coded a second time to develop codes inductively from the data. In the 
1429 
tradition of grounded theory, close attention will paid to making ‘constant comparisons’ to 
1430 
challenge the analysis and develop insights that will inform the subsequent trial.270 Our analysis 
1431 
will include both the ‘top-down’ structure of research questions and the ‘grounded’ voices of 
1432 
informants.271 Data on intervention implementation will inform recommendations for modification 
1433 
and scale up. 
1434 

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12.  TIME FRAME/DURATION OF THE PROJECT: 
1435 
 
1436 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Months 
0-6 
7-12 
0-6 
7-12 
0-6 
7-12 
0-6 
7-12 
0-6 
7-12 
Operationalize study procedures 
 
 
 
 
 
 
 
 
 
 
Site Selection 
 
 
 
 
 
 
 
 
 
 
Randomize facilities 
 
 
 
 
 
 
 
 
 
 
Hire & train researchers 
 
 
 
 
 
 
 
 
 
 
Recruit & enroll participants 
 
 
 
 
 
 
 
 
 
 
Implement study 
 
 
 
 
 
 
 
 
 
 
Process data for intervention scale up 
 
 
 
 
 
 
 
 
 
 
Analyze data/Prepare manuscripts  
 
 
 
 
 
 
 
 
 
 
 
1437 
13.  EXPECTED APPLICATION OF RESULTS 
1438 
 
1439 
The cluster RCT ultimately has the potential to improve the ways in which development and HIV 
1440 
health care and prevention services are conceptualized and delivered throughout rural Africa by 
1441 
demonstrating the role of sustainable agricultural and economic development in improving the 
1442 
health of HIV-positive individuals. As the proposed intervention will contribute to a dialogue 
1443 
between those involved in international agricultural policy and those involved in ART roll-out in 
1444 
sub-Saharan Africa, this approach, if effective, can help both sectors utilize their resources more 
1445 
effectively. Such collaborations are well positioned to contribute towards sustainable solutions 
1446 
that resolve the intersecting problems of food insecurity, poverty, HIV/AIDS and morbidity and 
1447 
mortality in sub-Saharan Africa. This intervention may also play an important role in improving 
1448 
women’s household bargaining power and relationship power.  
1449 
1450 

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