Clinical trial NCT06953310: Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
Official title: Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexually Transmitted Infection (STI)
HIV
Food Insecurity
Mental Health
Keywords: multisectoral agriculture intervention
sexual and reproductive health
Kenya
adolescent girls and young women
HIV
food insecurity
Shamba Maisha
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2025-05-01
Enrollment: 900
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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".


Eligibility 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.

Primary outcomes:
measure: STI Incidence (gonorrhea and/or chlamydia incidence)
timeFrame: 0, 6, 12, and 18 months
measure: Food insecurity - Household Food Insecurity Access Scale (HFIAS).
timeFrame: 0, 6, 12, 18 months
measure: Depression among adolescents - Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 0, 6, 12, and 18 months
Secondary outcomes:
measure: Body Mass Index (BMI) among adolescents
timeFrame: 0, 6, 12, 18 months
measure: Depression among caregivers - Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 0, 6, 12, 18 months
measure: Anxiety among adolescents - General Anxiety Disorder-7 (GAD-7)
timeFrame: 0, 6, 12, 18 months
measure: Pregnancy rate among adolescents
timeFrame: 0, 6, 12, 18 months
measure: Percent of sexually active adolescents who self-report condom use
timeFrame: 0, 6, 12, 18 months
measure: WHO Domestic Violence Module - Intimate Partner Violence among adolescents
timeFrame: 0, 6, 12, 18 months
measure: Parent-child communication
timeFrame: 0, 6, 12, 18 months
measure: Empowerment (Self-esteem) among adolescents - Rosenberg Self-Esteem Scale (RSES)
timeFrame: 0, 6, 12, 18 months
measure: Educational attainment among adolescents
timeFrame: 0, 6, 12, 18 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)
Study officials:
affiliation: University of California, San Francisco
name: Sheri Weiser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jennifer Velloza, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Maricianah Onono, MBChB, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen CR, Weke E, Frongillo EA, Sheira LA, Burger R, Mocello AR, Wekesa P, Fisher M, Scow K, Thirumurthy H, Dworkin SL, Shade SB, Butler LM, Bukusi EA, Weiser SD. Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2246158. doi: 10.1001/jamanetworkopen.2022.46158.
citation: Onono MA, Sheira L, Frongilio EA, Odhiambo G, Wekesa P, Conroy A, Bukusi EA, Cohen CR, Weiser SD. Effect of improving food security on parenting practices and caregiver-adolescent relationships: qualitative findings of an income-generating agricultural intervention in rural Kenya. BJPsych Open. 2024 Dec 26;11(1):e10. doi: 10.1192/bjo.2024.802.
citation: Onono MA, Frongillo EA, Sheira LA, Odhiambo G, Wekesa P, Conroy AA, Cohen CR, Bukusi EA, Weiser SD. Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry. J Nutr. 2023 Dec;153(12):3595-3603. doi: 10.1016/j.tjnut.2023.10.008. Epub 2023 Oct 18.
citation: Onono MA, Odhiambo G, Sheira L, Conroy A, Neilands TB, Bukusi EA, Weiser SD. The role of food security in increasing adolescent girls' agency towards sexual risk taking: qualitative findings from an income generating agricultural intervention in southwestern Kenya. BMC Public Health. 2021 Nov 6;21(1):2028. doi: 10.1186/s12889-021-12051-6.