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

Adolescent Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741634
• Other study ID #: 1R21HD095739
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Reproductive Behavior
• Sexual Behavior

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.

Locations

Country	Name	City	State
Kenya	Hongo Ogosa	Kisumu
Kenya	Kisumu District Hospital	Kisumu
Kenya	Lumumba	Kisumu
Kenya	Nyangande	Kisumu
Kenya	Osingo	Kisumu
Kenya	Pandiperi	Kisumu
Kenya	Railways	Kisumu
Kenya	Suna Ragana	Migori
Kenya	Muhuru Bay	Nyatike	Migori
Kenya	Sori Lakeside	Nyatike	Migori
Kenya	Minyenya	Rongo	Migori
Kenya	Ngode	Rongo	Migori
Kenya	Oyani	Rongo	Migori
Kenya	Kitare	Suba	Homa Bay
Kenya	Sindo	Suba	Homa Bay
Kenya	Nyamasare	Uriri	Migori

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety	Measured by the Generalized Anxiety Disorder Scale (GAD-7, 0-21 [least to most anxious]).	Endline / 2 years
Other	Empowerment	Measured by the Child and Youth Resilience Measure (CYRM-12, score range 12-60 [least to most resilient]).	Endline / 2 years
Other	School attendance	Days of school missed in previous term	Endline / 2 years
Primary	Food insecurity	Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 [least to most food insecure]).	Endline / 2 years
Primary	Depressive symptoms	Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 [least to most depressed].	Endline / 2 years
Primary	Unprotected sex	Percentage of time not used condoms over past six months	Endline / 2 years
Secondary	Percentage of participants who become pregnant	Measured by urine pregnancy test	Endline / 2 years
Secondary	Unintended pregnancy	Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy	Endline / 2 years
Secondary	HIV	Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines	Endline / 2 years
Secondary	HSV-2	HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.)	Endline / 2 years
Secondary	Body mass index-for-age-Z-score	Weight and height will be combined to report BMI in kg/m^2 as Z score	Endline / 2 years
Secondary	Physical health	Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 [poor to excellent health])	Endline / 2 years
Secondary	Number of sexual partners	Number of sexual partners over past six months	Endline / 2 years

External Links

•   Shamba Maisha study website