跳至主要内容
临床试验/NCT03880175
NCT03880175已完成不适用

Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique

University of Michigan1 个研究点 分布在 1 个国家目标入组 3,658 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,658
试验地点
1
主要终点
Indicator for school attendance at the child-level

研究概览

简要总结

The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being.

A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities").

This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics.

Follow-up data collection will begin in March 2019. It has several components:

  1. Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program.
  2. Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test.

In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community. 3. Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Households that lives in one of the eligible communities.

排除标准

  • •Households that are not in the eligible communities will not be included in the survey sample.

研究组 & 干预措施

FCC non-DEB and HIV info

Experimental

干预措施: HIV/AIDS Information (Behavioral)

FCC non-DEB and HIV info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary (Behavioral)

FCC DEB and ART info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- direct beneficiary (Behavioral)

FCC DEB and ART info

Experimental

干预措施: ART Information (Behavioral)

FCC DEB and HIV-ART info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- direct beneficiary (Behavioral)

FCC DEB and HIV-ART info

Experimental

干预措施: HIV/AIDS and ART Information Combined (Behavioral)

FCC DEB and high coupon value

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- direct beneficiary (Behavioral)

FCC DEB and high coupon value

Experimental

干预措施: High coupon value (Behavioral)

FCC DEB and no info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- direct beneficiary (Behavioral)

FCC non-DEB and Anti-stigma

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary (Behavioral)

FCC non-DEB and Anti-stigma

Experimental

干预措施: Anti Stigma Information (Behavioral)

FCC non-DEB and ART info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary (Behavioral)

FCC non-DEB and ART info

Experimental

干预措施: ART Information (Behavioral)

FCC non-DEB and HIV-ART info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary (Behavioral)

FCC non-DEB and HIV-ART info

Experimental

干预措施: HIV/AIDS and ART Information Combined (Behavioral)

FCC non-DEB and high coupon value

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary (Behavioral)

FCC non-DEB and high coupon value

Experimental

干预措施: High coupon value (Behavioral)

FCC non-DEB and no info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary (Behavioral)

FCC control and Anti-stigma

Experimental

干预措施: Anti Stigma Information (Behavioral)

FCC control and HIV info

Experimental

干预措施: HIV/AIDS Information (Behavioral)

FCC control and ART info

Experimental

干预措施: ART Information (Behavioral)

FCC control and HIV-ART info

Experimental

干预措施: HIV/AIDS and ART Information Combined (Behavioral)

FCC control and High coupon value

Experimental

干预措施: High coupon value (Behavioral)

FCC control and no info

No Intervention

FCC DEB and Anti-stigma

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- direct beneficiary (Behavioral)

FCC DEB and Anti-stigma

Experimental

干预措施: Anti Stigma Information (Behavioral)

FCC DEB and HIV info

Experimental

干预措施: FCC (Força à Comunidade e Crianças) program- direct beneficiary (Behavioral)

FCC DEB and HIV info

Experimental

干预措施: HIV/AIDS Information (Behavioral)

结局指标

主要结局

Indicator for school attendance at the child-level

时间窗: The time when the research team is conducting the school visit, which lasts 4 to 8 hours in each school

This is an individual-level binary variable. It takes value 1 if a school-aged child (6 -17 years of age) is physically present at school on the date the research staff conducts an unannounced school visit; it takes the value of 0 otherwise. The research team will make an unannounced school visit to check the attendance of all school-aged children in the study sample. All school-aged children will be checked regardless of his or her guardian-reported school attendance status. The study team will visit all public primary and secondary schools located in the study community. All unannounced visits will happen on regular school days. Each child will be checked in all neighboring schools. Each child will only be checked once in one school. The analysis sample of this outcome of interest is all school-aged children living in the study households.

Indicator for HIV testing coupon redemption at the household level

时间窗: 14 days following the date coupons are distributed to a household.

This is a household-level binary variable. It takes value 1 if at least one of a household's coupons is redeemed, and 0 otherwise. The researcher will distribute coupons at the household survey. A subject is eligible for a coupon if s/he is not reported HIV+ and has not had an HIV test within 3 months before the visit. A coupon for an adult will be distributed to themselves. A coupon for a child (age \<18) will be distributed to their primary guardian. Each coupon has a value of 50Mts (0.83 USD) and is valid for 14 days. To redeem a coupon, a coupon holder must show up in the designated clinic and provide proof of testing dated within the coupon-validity window. There is a unique barcode on each coupon to allow the researcher to track the use of each coupon. A coupon will be scanned when distributed and redeemed to link to a subject. The analysis sample for this outcome of interest is all households that have received at least one coupon from the researcher.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dean Yang

Professor

University of Michigan

研究点 (1)

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