Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women

Not Applicable

Not yet recruiting

• Conditions: Sexually Transmitted Infection (STI); Food Insecurity; HIV; Mental Health

• Registration Number: NCT06953310
• Lead Sponsor: University of California, San Francisco

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 (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study Start: 2025-05
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
STI Incidence (gonorrhea and/or chlamydia incidence)	0, 6, 12, and 18 months	Biologic samples
Food insecurity - Household Food Insecurity Access Scale (HFIAS).	0, 6, 12, 18 months	Household Food Insecurity Access Scale (HFIAS). Scores ranges from 0-27, with higher scores indicating higher food insecurity.
Depression among adolescents - Patient Health Questionnaire - 9 (PHQ-9)	0, 6, 12, and 18 months	Patient Health Questionnaire - 9 (PHQ-9) among adolescents. Scores range from 0 - 27, with higher scores indicating more severe depression.

Secondary Outcome Measures

Name	Time	Method
Percent of sexually active adolescents who self-report condom use	0, 6, 12, 18 months	Percent of sexually active adolescents who self-report condom use
Parent-child communication	0, 6, 12, 18 months	Parent-child communication: Families Matter! Program Tool
Body Mass Index (BMI) among adolescents	0, 6, 12, 18 months	Body Mass Index (BMI) among adolescents
Depression among caregivers - Patient Health Questionnaire - 9 (PHQ-9)	0, 6, 12, 18 months	Patient Health Questionnaire - 9 (PHQ-9) among caregivers. Scores range from 0 - 27, with higher scores indicating more severe depression.
Anxiety among adolescents - General Anxiety Disorder-7 (GAD-7)	0, 6, 12, 18 months	General Anxiety Disorder-7 (GAD-7) among adolescents. Scores range from 0 - 21, with higher scores indicating more severe anxiety.
Pregnancy rate among adolescents	0, 6, 12, 18 months	Pregnancy rate among adolescents
WHO Domestic Violence Module - Intimate Partner Violence among adolescents	0, 6, 12, 18 months	WHO Domestic Violence Module. Includes physical violence, sexual violence, and emotional abuse. Scores range from 0 to 52 with higher scores indicating more violence.
Empowerment (Self-esteem) among adolescents - Rosenberg Self-Esteem Scale (RSES)	0, 6, 12, 18 months	The Rosenberg Self-Esteem Scale (RSES). The scale ranges from 0-30, with higher scores indicating higher self-esteem.
Educational attainment among adolescents	0, 6, 12, 18 months	Self-Reported School attendance

Trial Locations

Locations (1)

Kenya Medical Research Institute (KEMRI); 🇰🇪 Nairobi, Kenya