Status:
RECRUITING
Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Kenya Medical Research Institute
National Institute of Mental Health (NIMH)
Conditions:
Sexually Transmitted Infection (STI)
HIV
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06953310
Start Date
May 20 2025
End Date
January 1 2028
Last Update
June 22 2025
Active Locations (1)
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1
Kenya Medical Research Institute (KEMRI)
Kisumu, Kenya