Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on Adolescent Girls' Health

Study Overview
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Brief Summary
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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
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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).

Official Title
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Shamba Maisha: Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on the Sexual and Reproductive Health of HIV-affected Adolescent Girls in Western Kenya

Conditions
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Adolescent Behavior, Sexual Behavior, Reproductive Behavior

Intervention / Treatment
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* Other: Multi-sectoral agricultural intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. | Other: Multi-sectoral agricultural intervention<br>* Adult participants in the intervention arm receive a loan ( $175) from a well-established Kenyan bank used to get a human-powered water pump, seeds, fertilizers and, pesticides, and education in financial management and sustainable farming practices.<br>|
| No Intervention: No intervention<br>During the study, participants enrolled at one study location will non receive the Multi-sectoral agricultural intervention. At the end of the study, participants in this arm will be eligible for education in financial management and sustainable farming practices and those who pay the loan down payment will be eligible for a small loan to purchase a human-powered water pump, seeds, fertilizers and, pesticides. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food insecurity | Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 [least to most food insecure]). | Endline / 2 years | 
| Depressive symptoms | Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 [least to most depressed]. | Endline / 2 years | 
| Unprotected sex | Percentage of time not used condoms over past six months | Endline / 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who become pregnant | Measured by urine pregnancy test | Endline / 2 years | 
| Unintended pregnancy | Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy | Endline / 2 years | 
| HIV | Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines | Endline / 2 years | 
| HSV-2 | HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.) | Endline / 2 years | 
| Body mass index-for-age-Z-score | Weight and height will be combined to report BMI in kg/m^2 as Z score | Endline / 2 years | 
| Physical health | Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 [poor to excellent health]) | Endline / 2 years | 
| Number of sexual partners | Number of sexual partners over past six months | Endline / 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent health, sexual health, reproductive health, food security