Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on Adolescent Girls' Health
- Conditions
- Reproductive BehaviorSexual BehaviorAdolescent Behavior
- Interventions
- Other: Multi-sectoral agricultural intervention
- Registration Number
- NCT03741634
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
The goal of this study is to understand how the Shamba Maisha household agricultural and economic intervention impacts the sexual, reproductive, and nutritional health of adolescent girls. The intervention includes: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (\~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices.
- Detailed Description
Food insecurity (FI) and poverty are important drivers of HIV vulnerability among adolescent girls, and contribute to worse sexual and reproductive health (SRH) outcomes. While most approaches to improving adolescent SRH outcomes have focused on individual-centered approaches alone, integrated family-level interventions that address the underlying context for risk behaviors such as poverty and FI may be more effective in reducing adverse SRH outcomes. A household-level multisectoral agricultural and finance intervention in Nyanza Region, Kenya called Shamba Maisha (SM) designed to mitigate household FI and improve health in HIV-affected households has been successfully developed and piloted. In mid-2016, a large cluster-randomized controlled trial (RCT) of SM was launched, targeting 704 adults and 352 young children to test the effectiveness of this intervention. This pilot study leverages the SM RCT infrastructure to recruit up to 240 adolescent girls residing in SM households and assess the impact of the SM intervention at the household level on adolescent girls' SRH outcomes at study endline. The central hypothesis is that improvements in household FI and wealth will contribute to reduced sexually transmitted infections (STIs), HIV, and unintended pregnancies among adolescent girls. To test this hypothesis, demographic, behavioral, clinical, and biological data from adolescent girls and their caregivers living in intervention and control SM households will be collected. The primary outcomes are food security, depressive symptoms, and sexual risk behaviors in the adolescent girls. The secondary outcomes are pregnancy/unintended pregnancy, HIV, herpes simplex virus 2 (HSV-2), and nutritional status in the adolescent girl.
The ultimate goal is to develop an intervention tailored specifically to the needs of adolescent girls to help reverse the cycle of FI, poverty, low empowerment, and poor SRH outcomes among adolescent girls. If proven efficacious, the proposed intervention may: 1) halt or slow down the cycle of incident HIV, other STIs, and unintended pregnancies to improve the lives of adolescent girls in similar settings, and 2) help achieve several top Sustainable Development Goals (SDG) including SDG 1 (zero poverty), SDG 2 (zero hunger), SDG 3 (good health and wellbeing), and SDG 5 (gender equality).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 241
- an adult participating in the parent study
- a currently unmarried adolescent girl aged 13-20 years old (preferred target of 15-19)
- the adolescent girl has a parent/primary guardian age >18 years old who resides in the household
- adolescent girls with a confirmed HIV diagnosis by clinical records prior to the start of SM
- married adolescent girls
- those who do not speak Dholuo, Swahili, or English
- those who are heads of households
- those ages 18 to 20 who are enrolled in the parent study
- those with inadequate cognitive and/or hearing capacity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Multi-sectoral agricultural intervention Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
- Primary Outcome Measures
Name Time Method Food insecurity Endline / 2 years Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 \[least to most food insecure\]).
Depressive symptoms Endline / 2 years Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 \[least to most depressed\].
Unprotected sex Endline / 2 years Percentage of time not used condoms over past six months
- Secondary Outcome Measures
Name Time Method Percentage of participants who become pregnant Endline / 2 years Measured by urine pregnancy test
Unintended pregnancy Endline / 2 years Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy
Physical health Endline / 2 years Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 \[poor to excellent health\])
HIV Endline / 2 years Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines
HSV-2 Endline / 2 years HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.)
Number of sexual partners Endline / 2 years Number of sexual partners over past six months
Body mass index-for-age-Z-score Endline / 2 years Weight and height will be combined to report BMI in kg/m\^2 as Z score
Trial Locations
- Locations (16)
Lumumba
🇰🇪Kisumu, Kenya
Minyenya
🇰🇪Rongo, Migori, Kenya
Muhuru Bay
🇰🇪Nyatike, Migori, Kenya
Pandiperi
🇰🇪Kisumu, Kenya
Sindo
🇰🇪Suba, Homa Bay, Kenya
Kitare
🇰🇪Suba, Homa Bay, Kenya
Oyani
🇰🇪Rongo, Migori, Kenya
Suna Ragana
🇰🇪Migori, Kenya
Sori Lakeside
🇰🇪Nyatike, Migori, Kenya
Ngode
🇰🇪Rongo, Migori, Kenya
Nyamasare
🇰🇪Uriri, Migori, Kenya
Hongo Ogosa
🇰🇪Kisumu, Kenya
Kisumu District Hospital
🇰🇪Kisumu, Kenya
Railways
🇰🇪Kisumu, Kenya
Nyangande
🇰🇪Kisumu, Kenya
Osingo
🇰🇪Kisumu, Kenya