Clinical trial NCT03741634: Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on Adolescent Girls' Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Sexual Behavior
Reproductive Behavior
Keywords: adolescent health
sexual health
reproductive health
food security
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2018-11-15
Enrollment: 241
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Food insecurity
timeFrame: Endline / 2 years
measure: Depressive symptoms
timeFrame: Endline / 2 years
measure: Unprotected sex
timeFrame: Endline / 2 years
Secondary outcomes:
measure: Percentage of participants who become pregnant
timeFrame: Endline / 2 years
measure: Unintended pregnancy
timeFrame: Endline / 2 years
measure: HIV
timeFrame: Endline / 2 years
measure: HSV-2
timeFrame: Endline / 2 years
measure: Body mass index-for-age-Z-score
timeFrame: Endline / 2 years
measure: Physical health
timeFrame: Endline / 2 years
measure: Number of sexual partners
timeFrame: Endline / 2 years
Other outcomes:
measure: Anxiety
timeFrame: Endline / 2 years
measure: Empowerment
timeFrame: Endline / 2 years
measure: School attendance
timeFrame: Endline / 2 years
Locations:
city: Suba
country: Kenya
facility: Kitare
state: Homa Bay
city: Suba
country: Kenya
facility: Sindo
state: Homa Bay
city: Nyatike
country: Kenya
facility: Muhuru Bay
state: Migori
city: Nyatike
country: Kenya
facility: Sori Lakeside
state: Migori
city: Rongo
country: Kenya
facility: Minyenya
state: Migori
city: Rongo
country: Kenya
facility: Ngode
state: Migori
city: Rongo
country: Kenya
facility: Oyani
state: Migori
city: Uriri
country: Kenya
facility: Nyamasare
state: Migori
city: Kisumu
country: Kenya
facility: Hongo Ogosa
city: Kisumu
country: Kenya
facility: Kisumu District Hospital
city: Kisumu
country: Kenya
facility: Lumumba
city: Kisumu
country: Kenya
facility: Nyangande
city: Kisumu
country: Kenya
facility: Osingo
city: Kisumu
country: Kenya
facility: Pandiperi
city: Kisumu
country: Kenya
facility: Railways
city: Migori
country: Kenya
facility: Suna Ragana
Study officials:
affiliation: University of California, San Francisco
name: Sheri D Weiser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.