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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03741634
Enrollment
241
Registered
2018-11-15
Start date
2018-12-05
Completion date
2019-12-20
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Reproductive Behavior, Sexual Behavior

Keywords

adolescent health, sexual health, reproductive health, food security

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.

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).

Interventions

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.

Sponsors

Kenya Medical Research Institute
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 20 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptomsEndline / 2 yearsDepression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 \[least to most depressed\].
Unprotected sexEndline / 2 yearsPercentage of time not used condoms over past six months
Food insecurityEndline / 2 yearsFood insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 \[least to most food insecure\]).

Secondary

MeasureTime frameDescription
Body mass index-for-age-Z-scoreEndline / 2 yearsWeight and height will be combined to report BMI in kg/m\^2 as Z score
Unintended pregnancyEndline / 2 yearsUnintended pregnancy as assessed by the London Measure of Unplanned Pregnancy
Physical healthEndline / 2 yearsAssessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 \[poor to excellent health\])
Number of sexual partnersEndline / 2 yearsNumber of sexual partners over past six months
Percentage of participants who become pregnantEndline / 2 yearsMeasured by urine pregnancy test
HIVEndline / 2 yearsSerial rapid HIV tests based on the Kenyan Ministry of Health guidelines
HSV-2Endline / 2 yearsHSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.)

Other

MeasureTime frameDescription
AnxietyEndline / 2 yearsMeasured by the Generalized Anxiety Disorder Scale (GAD-7, 0-21 \[least to most anxious\]).
School attendanceEndline / 2 yearsDays of school missed in previous term
EmpowermentEndline / 2 yearsMeasured by the Child and Youth Resilience Measure (CYRM-12, score range 12-60 \[least to most resilient\]).

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026