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临床试验/NCT03741634
NCT03741634已完成不适用

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

University of California, San Francisco16 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2018年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
16
主要终点
Food insecurity

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 20 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Food insecurity

时间窗: Endline / 2 years

Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 \[least to most food insecure\]).

Unprotected sex

时间窗: Endline / 2 years

Percentage of time not used condoms over past six months

Depressive symptoms

时间窗: Endline / 2 years

Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 \[least to most depressed\].

次要结局

  • Percentage of participants who become pregnant(Endline / 2 years)
  • Unintended pregnancy(Endline / 2 years)
  • Physical health(Endline / 2 years)
  • HIV(Endline / 2 years)
  • HSV-2(Endline / 2 years)
  • Number of sexual partners(Endline / 2 years)
  • Body mass index-for-age-Z-score(Endline / 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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