title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial is registered at ClinicalTrials.gov, NCT01548599.
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, 550 16th Street, San Francisco, CA 94158 USA ; Center of Expertise in Women's Health & Empowerment, University of California Global Health Institute, San Francisco, CA USA.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Cohen
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, 550 16th Street, San Francisco, CA 94158 USA.
authors.forename: Rachel L
authors.initials: RL
authors.lastname: Steinfeld
authors.affiliation: Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
authors.forename: Elly
authors.initials: E
authors.lastname: Weke
authors.affiliation: Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bukusi
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, 550 16th Street, San Francisco, CA 94158 USA ; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Abigail M
authors.initials: AM
authors.lastname: Hatcher
authors.affiliation: Departments of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Shiboski
authors.affiliation: Department of Environmental and Global Health, University of Florida, Gainesville, FL USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Rheingans
authors.affiliation: Department of Soil Science and Soil Microbial Biology, University of California Davis, Davis, CA USA.
authors.forename: Kate M
authors.initials: KM
authors.lastname: Scow
authors.affiliation: Boston Children's Hospital and Harvard Medical School, Boston, MA USA.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Butler
authors.affiliation: Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
authors.forename: Phelgona
authors.initials: P
authors.lastname: Otieno
authors.affiliation: Departments of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA USA ; Center of Expertise in Women's Health & Empowerment, University of California Global Health Institute, San Francisco, CA USA.
authors.forename: Shari L
authors.initials: SL
authors.lastname: Dworkin
authors.affiliation: Departments of Medicine, University of California San Francisco, San Francisco, CA USA ; Center of Expertise in Women's Health & Empowerment, University of California Global Health Institute, San Francisco, CA USA.
authors.forename: Sheri D
authors.initials: SD
authors.lastname: Weiser
keywords: Agriculture; Food insecurity; HIV; Intervention; Livelihoods; Microfinance