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

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ClinicalTrials.gov Identifier: NCT03741634
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adolescent Behavior Sexual Behavior Reproductive Behavior Other: Multi-sectoral agricultural intervention Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Intervention
Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
Other: Multi-sectoral agricultural intervention
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.

No Intervention: No intervention
During the study, participants enrolled at one study location will non receive the Multi-sectoral agricultural intervention. At the end of the study, participants in this arm will be eligible for education in financial management and sustainable farming practices and those who pay the loan down payment will be eligible for a small loan to purchase a human-powered water pump, seeds, fertilizers and, pesticides.



Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: Endline / 2 years ]
    Weight and height will be combined to report BMI in kg/m^2

  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741634


Contacts
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Contact: Sheri D Weiser, MD, MPH 415-206-2427 sheri.weiser@ucsf.edu
Contact: Lila Sheira, MPH lila.sheira@ucsf.edu

Locations
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Kenya
Kitare Recruiting
Suba, Homa Bay, Kenya
Sindo Recruiting
Suba, Homa Bay, Kenya
Muhuru Bay Enrolling by invitation
Nyatike, Migori, Kenya
Sori Lakeside Not yet recruiting
Nyatike, Migori, Kenya
Minyenya Not yet recruiting
Rongo, Migori, Kenya
Ngode Not yet recruiting
Rongo, Migori, Kenya
Oyani Not yet recruiting
Rongo, Migori, Kenya
Nyamasare Not yet recruiting
Uriri, Migori, Kenya
Hongo Ogosa Recruiting
Kisumu, Kenya
Kisumu District Hospital Recruiting
Kisumu, Kenya
Lumumba Recruiting
Kisumu, Kenya
Nyangande Recruiting
Kisumu, Kenya
Osingo Recruiting
Kisumu, Kenya
Pandiperi Recruiting
Kisumu, Kenya
Railways Recruiting
Kisumu, Kenya
Suna Ragana Not yet recruiting
Migori, Kenya
Sponsors and Collaborators
University of California, San Francisco
Kenya Medical Research Institute
Investigators
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Principal Investigator: Sheri D Weiser, MD, MPH University of California, San Francisco

Additional Information:
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03741634     History of Changes
Other Study ID Numbers: 1R21HD095739 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
adolescent health
sexual health
reproductive health
food security