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Completed

NCT Number: NCT03741634

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

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.

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Key information

Age range

13 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kitare, Suba, Homa Bay County, Kenya

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-sectoral agricultural intervention

Other

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.

Primary outcomes

  1. Food insecurity

    Time frame: Endline / 2 years

    Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 [least to most food insecure]).

  2. Depressive symptoms

    Time frame: Endline / 2 years

    Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 [least to most depressed].

  3. Unprotected sex

    Time frame: Endline / 2 years

    Percentage of time not used condoms over past six months

Secondary outcomes

  1. Percentage of participants who become pregnant

    Time frame: Endline / 2 years

    Measured by urine pregnancy test

  2. Unintended pregnancy

    Time frame: Endline / 2 years

    Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy

  3. HIV

    Time frame: Endline / 2 years

    Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines

  4. HSV-2

    Time frame: Endline / 2 years

    HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.)

  5. Body mass index-for-age-Z-score

    Time frame: Endline / 2 years

    Weight and height will be combined to report BMI in kg/m^2 as Z score

  6. Physical health

    Time frame: Endline / 2 years

    Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 [poor to excellent health])

  7. Number of sexual partners

    Time frame: Endline / 2 years

    Number of sexual partners over past six months

Other outcomes

  1. Anxiety

    Time frame: Endline / 2 years

    Measured by the Generalized Anxiety Disorder Scale (GAD-7, 0-21 [least to most anxious]).

  2. Empowerment

    Time frame: Endline / 2 years

    Measured by the Child and Youth Resilience Measure (CYRM-12, score range 12-60 [least to most resilient]).

  3. School attendance

    Time frame: Endline / 2 years

    Days of school missed in previous term

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Kenya Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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