Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial
Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, 550 16th Street, San Francisco, CA, United States; Departments of Medicine, University of California San Francisco, San Francisco, CA, United States; Departments of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, United States; Departments of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, United States; Center of Expertise in Women’s Health & Empowerment, University of California Global Health Institute, San Francisco, CA, United States; Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya; Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya; Department of Environmental and Global Health, University of Florida, Gainesville, FL, United States; Department of Soil Science and Soil Microbial Biology, University of California Davis, Davis, CA, United States; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa; Boston Children’s Hospital and Harvard Medical School, Boston, MA, United States
Background: Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. Methods/Design: We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women’s empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) <18.5, and access to land and surface water were eligible for enrollment. The intervention included: 1) a microfinance loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3–5 months after study start and at study end. Discussion: Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p < 0.010). Process evaluation findings suggested that Shamba Maisha had high acceptability in recruitment, delivered strong agricultural and financial training, and led to labor saving due to use of the water pump. Implementation challenges included participant concerns about repaying loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. Trial registration: This trial is registered at ClinicalTrials.gov, NCT01548599. © 2015, Cohen et al.; licensee Springer.
1R34MH094215, NIMH, National Institute of Mental Health