- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741634
Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on Adolescent Girls' Health
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
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kisumu, Kenya
- Hongo Ogosa
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Kisumu, Kenya
- Kisumu District Hospital
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Kisumu, Kenya
- Lumumba
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Kisumu, Kenya
- Nyangande
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Kisumu, Kenya
- Pandiperi
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Kisumu, Kenya
- Railways
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Kisumu, Kenya
- Osingo
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Migori, Kenya
- Suna Ragana
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Homa Bay
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Suba, Homa Bay, Kenya
- Kitare
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Suba, Homa Bay, Kenya
- Sindo
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Migori
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Nyatike, Migori, Kenya
- Muhuru Bay
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Nyatike, Migori, Kenya
- Sori Lakeside
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Rongo, Migori, Kenya
- Minyenya
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Rongo, Migori, Kenya
- Ngode
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Rongo, Migori, Kenya
- Oyani
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Uriri, Migori, Kenya
- Nyamasare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food insecurity
Time Frame: Endline / 2 years
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Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 [least to most food insecure]).
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Endline / 2 years
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Depressive symptoms
Time Frame: Endline / 2 years
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Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 [least to most depressed].
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Endline / 2 years
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Unprotected sex
Time Frame: Endline / 2 years
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Percentage of time not used condoms over past six months
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Endline / 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants who become pregnant
Time Frame: Endline / 2 years
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Measured by urine pregnancy test
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Endline / 2 years
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Unintended pregnancy
Time Frame: Endline / 2 years
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Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy
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Endline / 2 years
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HIV
Time Frame: Endline / 2 years
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Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines
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Endline / 2 years
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HSV-2
Time Frame: Endline / 2 years
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HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.)
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Endline / 2 years
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Body mass index-for-age-Z-score
Time Frame: Endline / 2 years
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Weight and height will be combined to report BMI in kg/m^2 as Z score
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Endline / 2 years
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Physical health
Time Frame: Endline / 2 years
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Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 [poor to excellent health])
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Endline / 2 years
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Number of sexual partners
Time Frame: Endline / 2 years
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Number of sexual partners over past six months
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Endline / 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Endline / 2 years
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Measured by the Generalized Anxiety Disorder Scale (GAD-7, 0-21 [least to most anxious]).
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Endline / 2 years
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Empowerment
Time Frame: Endline / 2 years
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Measured by the Child and Youth Resilience Measure (CYRM-12, score range 12-60 [least to most resilient]).
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Endline / 2 years
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School attendance
Time Frame: Endline / 2 years
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Days of school missed in previous term
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Endline / 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sheri D Weiser, MD, MPH, University of California, San Francisco
Publications and helpful links
General Publications
- Pandit JA, Sirotin N, Tittle R, Onjolo E, Bukusi EA, Cohen CR. Shamba Maisha: a pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patients. BMC Public Health. 2010 May 11;10:245. doi: 10.1186/1471-2458-10-245.
- Zakaras JM, Weiser SD, Hatcher AM, Weke E, Burger RL, Cohen CR, Bukusi EA, Dworkin SL. A Qualitative Investigation of the Impact of a Livelihood Intervention on Gendered Power and Sexual Risk Behaviors Among HIV-Positive Adults in Rural Kenya. Arch Sex Behav. 2017 May;46(4):1121-1133. doi: 10.1007/s10508-016-0828-x. Epub 2016 Aug 9. Erratum In: Arch Sex Behav. 2017 May;46(4):1135.
- Weiser SD, Bukusi EA, Steinfeld RL, Frongillo EA, Weke E, Dworkin SL, Pusateri K, Shiboski S, Scow K, Butler LM, Cohen CR. Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes. AIDS. 2015 Sep 10;29(14):1889-94. doi: 10.1097/QAD.0000000000000781.
- Cohen CR, Steinfeld RL, Weke E, Bukusi EA, Hatcher AM, Shiboski S, Rheingans R, Scow KM, Butler LM, Otieno P, Dworkin SL, Weiser SD. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial. Springerplus. 2015 Mar 12;4:122. doi: 10.1186/s40064-015-0886-x. eCollection 2015.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R21HD095739 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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