Shamba Maisha: a household farming program to improve sexual and reproductive health for adolescent girls and young women in Western Kenya
Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
NA · University of California, San Francisco · NCT06953310
This project will try a household-level agricultural program (Shamba Maisha) with adolescent girls and young women (ages 15–19) and their caregivers in Western Kenya to see if improving food security reduces HIV and other STI risk and improves reproductive and mental health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT06953310 on ClinicalTrials.gov |
What this trial studies
The intervention, called Shamba Maisha, provides a multisectoral agricultural package to households of adolescent girls and young women (AGYW) in Kisumu and Migori counties who report moderate to severe food insecurity. AGYW participants are 15–19 years old, STI-uninfected and not pregnant at baseline, and enroll with an adult caregiver in a household that has farming land and nearby surface water. The trial measures sexual and reproductive health outcomes, including HIV/STI incidence, alongside indicators of food security and mental health to determine whether household-level economic and agricultural support changes risk. The program targets school-attending AGYW with at least 18 months remaining of schooling and uses household enrollment criteria to focus on households likely to implement agricultural changes.
Who should consider this trial
Good fit: Ideal participants are AGYW aged 15–19 who are STI-uninfected, not pregnant, attend selected schools with ≥18 months remaining, live in food-insecure households with farming land and surface water, and have an adult caregiver willing to enroll.
Not a fit: Those unlikely to benefit include AGYW who are already pregnant or STI-positive at baseline, households without access to farmland or nearby surface water, or individuals without a willing adult caregiver to participate.
Why it matters
Potential benefit: If successful, the program could lower HIV and STI risk and improve reproductive and mental health for food-insecure adolescent girls and young women by reducing poverty and improving household food supply.
How similar studies have performed: Previous poverty-alleviation interventions have shown mixed effects on HIV/STI outcomes, and household agricultural interventions focused on food insecurity for AGYW remain relatively novel and unproven in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adolescent Girls and Young women (AGYW): * AGYW assigned female at birth * Between 15-19 years of age at enrollment * Attending the selected schools with at least 18 months remaining of schooling * STI-uninfected and not pregnant at baseline * Has an adult caregiver willing to participate * Demonstrates moderate to severe FI based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI less than two standard deviations below the mean for age-specific BMI Caregiver: * At least 18 years old. * At least 1 AGYW aged 15-19 years old attending the selected schools * household has access to farming land * household has available surface water in the form of lakes, rivers, ponds, or shallow wells (home is 200m from permanent water source) Exclusion Criteria: * AGYW or adult caregivers who have inadequate cognitive and/or hearing capacity to complete planned study procedures * AGYW or adult caregivers who do not speak Dholuo, Kiswahili, or English * Married AGYW and those who serve as heads of households * AGYW who are pregnant at screening Adolescent girls who test positive for gonorrhea or chlamydia at screening will be invited to re-screen at least 14 days after receiving treatment and will be eligible to enroll if they have a confirmatory negative STI test.
Where this trial is running
Kisumu
- Kenya Medical Research Institute (KEMRI) — Kisumu, Kenya (RECRUITING)
Study contacts
- Principal investigator: Sheri Weiser, MD, MPH — University of California, San Francisco
- Study coordinator: Rachel L Burger, MHS
- Email: rachel.burger@ucsf.edu
- Phone: 415-535-2650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sexually Transmitted Infection, HIV, Food Insecurity, Mental Health, multisectoral agriculture intervention, sexual and reproductive health, Kenya, adolescent girls and young women