Shamba Maisha Protocol

1. Title: Shamba Maisha: Agricultural intervention for food security and HIV health outcomes in Kenya

2. Investigators and Institutional Affiliations

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

 

1. COLLABORATING INSTITUTIONS

University of California San Francisco (UCSF)

UCSF is the only University of California campus dedicated exclusively to the health sciences and is home to graduate professionals in medicine, nursing, pharmacy, and dentistry, and a graduate division for pre-doctoral and postdoctoral scientists. In addition to its main campus, where the Schools of Medicine, Nursing, Pharmacy, and Dentistry and the UCSF Medical Center are located, UCSF encompasses several major sites in San Francisco, including UCSF Mount Zion, the Comprehensive Cancer Center, and Mission Bay. UCSF is considered one of the United States’ premier health sciences, training, and research centers and has a well-established reputation in biomedical research.

UCSF Department of Medicine The Department of Medicine has been the number one recipient of research dollars from the National Institutes of Health (NIH) among all departments of internal medicine in the nation. Eight of the adult specialty clinical programs are ranked in the top 10 by the US News & World Report ‑ AIDS, Diabetes & Endocrinology, Primary Care, Cancer, Kidney Disorders, Pulmonology, Geriatrics and Rheumatology. The department's continued success in this highly competitive arena attests to the quality and impact of the research performed by its basic and clinical scientists.

UCSF Department of Obstetrics/Gynecology and Reproductive Sciences: The Department boasts a diverse portfolio of research activities, from basic biological, translational, and clinical investigation to epidemiological inquiry and the development of public health policy. The Department is home to the University of California National Center of Excellence in Women's Health. The Department’s exemplary academic reputation (consistently among the top three departments of obstetrics and gynecology in the nation to receive federal funding) derives from long-standing integrative and multidisciplinary partnerships within the UCSF community of nursing and medical scholars.

UCSF Department of Epidemiology and Biostatistics

The UCSF Department of Epidemiology & Biostatistics - the largest department of epidemiology in the University of California system in terms of full-time primary faculty and the number of affiliated faculty.  It aims to carry out its educational, scientific, and clinical missions within the highly interdisciplinary culture of UCSF and to take a transdisciplinary approach to education and research.

UCSF AIDS Division:  Positive Health Program (PHP)

Drs. Sheri Weiser is a faculty member in the PHP/HIV/AIDS Division at San Francisco General Hospital. The HIV/AIDS Division is part of the Department of Medicine at UCSF. PHP consists of a multidisciplinary HIV/AIDS clinic, an AIDS Inpatient Unit, and a strong clinical research program. The program has focused on clinical, research and educational issues of HIV and HIV-associated illnesses (e.g., sexually transmitted and blood borne infections) for over 25 years. Academically, PHP holds weekly clinical grand rounds, monthly research forums and periodic seminars, which provide ample opportunity for peer review as well as dissemination of study information. The Positive Health Program has become an internationally recognized center of clinical excellence and "standard-setter" for HIV care, pioneering a number of medical and scientific advances. The treatment model practiced at PHP has been widely adopted around the world. PHP has also had a major presence in the developing world, training local providers and leading global research. PHP's faculty is among the most cited in scientific publications and conducts work in all major areas of HIV science.

UCSF Center for AIDS Prevention Studies (CAPS)

Dr. Sheri Weiser holds a secondary appointment at CAPS. The mission of CAPS is to develop research focused on three long-term goals: preventing new HIV infections, behavioral approaches to optimizing health outcomes among HIV-infected people, and reducing disparities. These goals are advanced through multidisciplinary research supported by six cores. CAPS is located at 550 16^th Street along with the AIDS Research Institute (ARI) administrative offices, the Pacific AIDS Education and Training Center (PAETC) and the UCSF program in Global Health Sciences (GHS).  CAPS hosts a weekly town hall series, in which scientists from UCSF and around the world present findings from their ongoing and recent research. In addition, the UCSF Global Health Sciences program (co-located with CAPS) hosts a regular speaker series and offers a degree program with classes in epidemiology, biostatistics, and qualitative and quantitative behavioral research methods.

Both CAPS and PHP are programs of the AIDS Research Institute (ARI). The AIDS research program at UCSF constitutes an organized set of research activities aimed at all aspects of the epidemic domestically and internationally. ARI is committed to harnessing the extraordinary resources of UCSF to advance scientific discovery in the service of fighting HIV/AIDS. UCSF faculty represent a mix of expertise in the basic, clinical, prevention, and policy sciences. The faculty is internationally renowned for their contributions to immunology, virology, vaccine research, pediatrics, genetics, behavioral science, and advanced treatment research. Further, UCSF scientists have the expertise in health economics, epidemiology, and health care delivery needed to determine how optimal treatments can be integrated into evolving health care systems to reach all HIV-affected populations. ARI brings together scientists from the four professional schools at UCSF (Medicine, Dentistry, Pharmacy, and Nursing), from the UCSF-affiliated laboratories (The Gladstone Institute of Virology and Immunology, Blood Centers of the Pacific, and the California State Labs), the San Francisco Department of Public Health, and the School of Public Health at UC Berkeley. Activities are conducted at all four hospital sites: Parnassus, San Francisco General, Mt. Zion, and the SF Veterans Affairs Medical Center.

UCSF Bixby Center for Global Reproductive Health: The Bixby Center was formed in 1999 to integrate research and training efforts in contraception and family planning with work in sexually transmitted infections (STIs) and HIV/AIDS. Projects and research range from primary prevention to treatment interventions and include epidemiologic and behavioral approaches, clinical and biomedical research, and public health and policy development, as well as leadership training programs. Faculty and staff from diverse disciplines, including medicine, epidemiology, public health, sociology and anthropology, use sound science to seek solutions to the reproductive health issues of most pressing concern to women, men and youth in the United States and internationally.

 

UCSF Department of Social & Behavioral Sciences, School of Nursing: The Department of Social and Behavioral Sciences (SBS) research mission is to advance knowledge through theory and research; to design and evaluate the organization, financing, and delivery of health care; and to examine one broad dynamics of health, healing, and the production of knowledge and its application in these domains.

UC Global Health Institute (UGCHI)

UCGHI advances the mission of the 10-campus University of California system to improve the lives of people in California and around the world. By stimulating education, research, and partnerships, UCGHI leverages the diverse intellectual resources across the University to train the next generation of global health leaders and accelerate the discovery and implementation of transformative global health solutions.  UCGHI includes three Centers of Expertise (COE), including the COE in Women’s Health & Empowerment (WHE).  The COE in WHE believes that advances in women’s health globally are impeded by poverty, limited access to educational and economic opportunities, gender bias and discrimination, unjust laws, and insufficient state accountability. By prioritizing women’s health concerns, rights, and empowerment, this COE is uniquely poised to catalyze societal-level changes that will yield sustainable improvements in health and well-being for women on a global scale. 

Kenya Medical Research Institute (KEMRI)

The Kenya Medical Research Institute (KEMRI) is one of the leading health research institutes in Africa. KEMRI was established in 1979 under the Science and Technology (Amendment) Act of that year to represent the national body responsible for carrying out health science research in Kenya. KEMRI’s mission is to conduct health research and generate research findings to be applied towards improvement of health in Kenya and the world over. Under the Amendment Act, KEMRI was charged with the responsibility of carrying out health research with the following mandates:  

1. To carry out research in the field of biomedical sciences; 

2. To co-operate with other organizations and other institutions of higher learning in training programs and on matters of relevant research; 

3. To liaise with other research bodies within and outside Kenya carrying out similar research; 

4. To disseminate research findings; 

• To co-operate with the Ministry of Health, the Ministry responsible for research, the National Council for Science and Technology, and the Medical Science Advisory Committee on matters pertaining to research policies and priorities.   

 

With health research and training expertise in infectious disease, parasitic disease, epidemiology, and biotechnology and non-communicable diseases, KEMRI has grown to become one of the leading centers of excellence in health research development and Africa’s largest health research institute. KEMRI has trained cadres of professionals and maintains over 80 professors with PhD degrees or equivalent, over 148 with MA or equivalent, and nearly 400 highly trained and skilled technical staff. As a partner in global health initiatives, KEMRI collaborates with the World Health Organization (WHO), the Japan International Cooperation Agency (JICA), U.S. Center for Disease Control and Prevention (CDC), among others. KEMRI serves as the Collaborating Center for HIV/AIDS, Tropical Research, Polio Immunization, Viral Hemorrhagic Fevers, and Anti-Microbial Resistance.  

Research, Training, and Care Program (RTCP), KEMRI

Drs. Bukusi and Cohen with others established the Research, Training, and Care Program (RTCP) with KEMRI and the University of Nairobi in 1994. Through this collaboration, Dr. Cohen and Dr. Elizabeth Bukusi (KEMRI) established the Research, Care, and Treatment Program (RCTP), a program with research projects in Nyanza Province and Nairobi, Kenya.  In 2007, RCTP became registered as an NGO in Kenya and in 2013, the name of the NGO was changed to RCTP-FACES.  In addition to facilitating collaborative research on STIs and HIV treatment and prevention between investigators from the US and Kenyan counterparts, the mission of RCTP-FACES is to provide administrative management of the biomedical research conducted by researchers from KEMRI, UCSF, and other collaborating institutions. The largest RCTP-FACES program is the PEPFAR/CDC-funded Family AIDS Care and Education Services (FACES) program, which works with the government of Kenya to strengthen comprehensive HIV prevention, care, and treatment service delivery and expand primary prevention efforts in Nyanza and Nairobi Provinces.

University of South Carolina (USC)

Established in 1801, USC is a full-service, state-supported research university that includes the 358-acre Columbia campus and seven regional campuses with a total full-time student body population of more than 39,500 and 2,100 full-time faculty members. USC offers a broad spectrum of educational opportunities with 14 colleges and schools that encompass 324 undergraduate and graduate degree-granting programs.

The Arnold School of Public Health (ASPH) Based at USC's main campus in Columbia,  ASPH is one of 49 schools of public health fully accredited by the Council on Education for Public Health (CEPH), and is accredited through 2017. Dr. Edward Frongillo is a professor and chair of the Department of Health Promotion, Education, and Behavior (HPEB) at the USC. This department has as its focus understanding how policy, environmental, institutional, and individual actions can improve the public’s health. This work, usually done in partnership with organizations and communities, uses principles and methods from the social and behavioral sciences to promote health in diverse settings across South Carolina, the US, and the globe.

University Of Pennsylvania

Academic life at the University of Pennsylvania, Penn, is unparalleled, with 100 countries and every U.S. state represented in one of the Ivy League’s most diverse student bodies. Consistently ranked among the top 10 universities in the country, Penn enrolls 10,000 undergraduate students and welcomes an additional 10,000 students to our world-renowned graduate and professional schools.  Penn is one of the world's most powerful research and teaching institutions, with a research budget last year of nearly $1 billion and more than 4,000 active faculty members. The scale and interdisciplinary character of research and teaching sets Penn apart, and our highly ranked Perelman School of Medicine is one of the top recipients of NIH funding in the country.

Department of Medical Ethics and Health Policy at the Perelman School of Medicine

The Department is one of the premier institutions of research and education in medical ethics and health policy in the world. The Department's distinguished faculty produce and disseminate scholarship and lead three bioethics master’s degree programs. In addition to their own projects, faculty members supervise research being carried out by undergraduates, graduate students, medical students, doctoral students and post-doctoral fellows. The Department’s presence in the world of biomedical ethics education is ever-growing.   In 2017, the department will launch the Master of Health Care Innovation, an online master's program aiming to training future leaders in health policy, administration, and ethics.

University of Connecticut

The University of Connecticut is one of the top public research universities in the United States, with more than 30,000 students pursuing answers to critical questions in labs, lecture halls, and the community. Knowledge exploration throughout the University’s network of campuses is united by a culture of innovation. An unprecedented commitment from the state of Connecticut ensures UConn attracts internationally renowned faculty and the world’s brightest students. As a vibrant, progressive leader, UConn fosters a diverse and dynamic culture that meets the challenges of a changing global society.

The Institute for Collaboration on Health, Intervention, and Policy

The University of Connecticut’s Institute for Collaboration on Health, Intervention, and Policy (InCHIP) is a multidisciplinary research institute dedicated to the creation and dissemination of new scientific knowledge and theoretical frameworks in the areas of health behavior, health behavior change, and health intervention and prevention at multiple levels of analysis (e.g., individual, environmental, social, and policy). InCHIP researchers lead novel, influential health behavior change initiatives at UConn, institutions across the United States, and globally in countries including Albania, Brazil, China, Kenya, Ethiopia, India, Mozambique, South Africa, Russia, Uganda, and Vietnam. Our investigators have expertise in the areas of HIV prevention and treatment adherence, diabetes management, cancer prevention and control, nutrition, pharmacology, substance abuse, obesity, autism, digital health technologies, school and child health, and complementary and alternative approaches to medicine, among other health domains.

KickStart

KickStart, an international NGO, developed a low-cost micro-irrigation pump which is purchased by local entrepreneurs and used to establish small agricultural businesses. These pumps enable farmers to irrigate their crops year-round avoiding dependence on seasonal rainfall thus capitalizing on higher crop prices in the marketplace. KickStart has been one of the leaders in micro-irrigation technologies since 1991, through the development and sales of manually operated “MoneyMaker” pumps, which are now widely available in Kenya.

3. ABSTRACT

Despite major advances in care and treatment for those living with HIV, morbidity and mortality among people living with HIV/AIDS (PLHIV) remain unacceptably high in sub-Saharan Africa (SSA), largely due to the parallel challenges of poverty and food insecurity.  Food insecurity and poverty contribute to higher morbidity and mortality among PLHIV, and there has been increasing international recognition of the need to address these factors for a successful global response to the HIV epidemic. Yet, to date there have been few studies to systematically evaluate the impact and cost-effectiveness of promising food security interventions on health outcomes among PLHIV. To address these gaps, together with KickStart, a non-governmental organization based in SSA, we have developed a multisectoral intervention in Nyanza Region, Kenya that includes: a) a loan (~$175) for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the loan including a human-powered water pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices. We successfully completed a pilot intervention trial that showed that the intervention was feasible, acceptable and may improve HIV-related health. We now plan to conduct a cluster randomized controlled trial (RCT) of this intervention with the following specific aims: Aim 1: To determine the impact of a multisectoral agricultural intervention among HIV-infected farmers on ART on HIV clinical outcomes. We hypothesize that the intervention will lead to improved viral load suppression (primary outcome) and decreased HIV-related morbidity in the intervention arm compared to the control arm. Aim 2: To understand the pathways through which the multisectoral intervention may improve HIV health outcomes. Using our theoretical model, we hypothesize that the intervention will improve food security and household wealth, which in turn will contribute to improved outcomes through nutritional (improved diet quality, nutritional status), mental health (less depression, improved empowerment), and behavioral (improved ART adherence, and retention in care) pathways. Aim 3: To determine the cost-effectiveness of the intervention and obtain the information necessary to inform scale-up in Kenya and similar settings in SSA.  We hypothesize that the intervention will be cost-effective, and that we will be able to translate lessons learned into successful scale up. To accomplish Aims 1 & 2, we will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and enroll up to 65 participants per facility (total up to n=1,040). All participants will be followed for 2 years. To accomplish Aim 3, we will: a) conduct a cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from the intervention (e.g., gender, education, family size, wealth, risk tolerance, etc.); and c) perform a mixed-methods process evaluation to guide future scale-up efforts of the intervention. Our ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and HIV/AIDS morbidity and mortality in SSA.        

4. LAY SUMMARY

We plan to test the hypothesis that a multisectoral agricultural and finance intervention will improve food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.

5. BACKGROUND

HIV/AIDS and food insecurity are two of the leading causes of morbidity and mortality in sub-Saharan Africa (SSA).^1-6 There are an estimated 35.3 million people living with HIV/AIDS (PLHIV) worldwide, 70.8% of whom live in SSA.⁷ Food insecurity, defined as ”the limited or uncertain availability of nutritionally adequate, safe foods or the inability to acquire personally acceptable foods in socially acceptable ways,”⁸ is also highly prevalent in SSA. As of 2013, 223 million people were food insecure in SSA, an estimated 25% of the population.⁹ Food insecurity in the region stems from the combined effects of extreme poverty, infections, environmental change, insufficient agricultural output, rising food prices, and high rates of population growth.^10,11 While the agricultural sector accounts for 51% of Kenya’s gross domestic product ¹², crop productivity is low because of limited irrigation, unreliable rainfall patterns, and land that is highly depleted of nutrients.¹³ At the same time, food prices have increased since 1995 due to globalization, economic shifts and human conflict.¹¹ The prevalence of Critical Food Poverty (pCFP) (the proportion of the population whose daily income is lower than the cost of a macronutrient-balanced food basket that meets minimum dietary needs) in the Nyanza Region of Kenya is 28%, exceeding the national average.¹⁴ The prevalence of food insecurity is even higher among PLHIV in SSA. Studies from Kenya and Uganda have found that 70% or more of PLHIV are moderately or severely food-insecure.^15-17

Food insecurity and HIV/AIDS are intertwined through biological, behavioral, and socio-economic pathways. Our novel evidence-based causal framework (Figure 1) builds upon our previously-published conceptual framework^18,19 adapted from existing theoretical models for understanding the linkages between HIV/AIDS, food security, and socio-economic well-being.^3,18,20-22 The bi-directional linkages between HIV/AIDS and food insecurity are embedded within a context of weak healthcare systems, poor agricultural infrastructure, and entrenched poverty. These structural determinants of health interact to create a vicious cycle of household poverty, food insecurity, and ill-health.^20,22 Each condition heightens the vulnerability to, and worsens the severity of the other. For example, if a household affected by HIV/AIDS has few agricultural skills, they may experience food insecurity and poverty (A1, A2) leading to malnutrition (A4a), decreased ART adherence (A4b), poor mental health (A4c), and disempowerment (A4d). These, in turn, can worsen immunologic and virologic responses, and lead to increased morbidity and mortality (A3). Likewise, when a household loses a family member to HIV-related illness or death, they are less able to produce agricultural outputs and may sell off household assets as a source of income. This further cements families into the cycle of poverty and food insecurity (A5, A6). In the sections that follow, we provide evidence for each linkage in our causal framework.

Food insecurity and poverty are key contributors to poor health outcomes among PLHIV receiving treatment. In studies by our group and others, food insecurity has been associated with a range of adverse clinical effects among PLHIV on ART, including declines in physical health status,^16,23,24 decreased viral suppression,^25-28 worse immunologic status,^23,25,29,30 increased incidence of serious illness,^16,31,32 and increased mortality. ^33,34 In several longitudinal analyses, we found that after controlling for clinical and socioeconomic variables, HIV-infected people who were food insecure were 50%-95% more likely to die compared with individuals who were not food insecure.^33,34 Studies have also documented negative health impacts of other indicators of low socioeconomic status (SES) for HIV.³⁵ For example, in a prospective cohort study in Uganda, we found that lack of education, unemployment and lower wealth index were associated with mortality.³⁶ In Kenya, we have demonstrated an association between low SES and lower CD4 increase upon ART initiation.³⁷

Food insecurity and poverty can impact HIV outcomes through four mediating pathways: nutritional, behavioral, mental health and empowerment (Figure 1).

1) Nutritional pathways: Food insecurity is associated with macronutrient and micronutrient malnutrition,^38,39 and malnutrition in turn has been shown to hasten progression to AIDS and death.^40-43   Among HIV-infected individuals, weight loss, low body mass index (BMI), and low albumin have been shown to predict opportunistic infections, immunologic decline, and shorter survival time in both untreated and ART treated individuals.^44-52 HIV increases metabolic requirements^50,53 and is associated with diarrhea and malabsorption of fat and carbohydrates,^53-56 which further compounds the links between malnutrition and disease progression. Also, lack