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Direct and Spillover Impacts of a Community-Level HIV/AIDS Program (FCC)

2021年8月11日 更新者:Dean Yang、University of Michigan

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

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.

研究概览

研究类型

介入性

注册 (实际的)

3658

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sofala
      • Beira、Sofala、莫桑比克
        • Lessitala Consultoria e Servicos

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Households that lives in one of the eligible communities.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:FCC DEB and Anti-stigma
Households are directly linked to the FCC implementing organization
Adults in the households are provided anti-stigma information
实验性的:FCC DEB and HIV info
Households are directly linked to the FCC implementing organization
The households receive information about HIV infection and AIDS
实验性的:FCC DEB and ART info
Households are directly linked to the FCC implementing organization
The households receive information about antiretroviral therapy.
实验性的:FCC DEB and HIV-ART info
Households are directly linked to the FCC implementing organization
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
实验性的:FCC DEB and high coupon value
Households are directly linked to the FCC implementing organization
The HIV testing coupons distributed to households in this group have higher values.
实验性的:FCC DEB and no info
Households are directly linked to the FCC implementing organization
实验性的:FCC non-DEB and Anti-stigma
Adults in the households are provided anti-stigma information
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
实验性的:FCC non-DEB and HIV info
The households receive information about HIV infection and AIDS
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
实验性的:FCC non-DEB and ART info
The households receive information about antiretroviral therapy.
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
实验性的:FCC non-DEB and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
实验性的:FCC non-DEB and high coupon value
The HIV testing coupons distributed to households in this group have higher values.
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
实验性的:FCC non-DEB and no info
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
实验性的:FCC control and Anti-stigma
Adults in the households are provided anti-stigma information
实验性的:FCC control and HIV info
The households receive information about HIV infection and AIDS
实验性的:FCC control and ART info
The households receive information about antiretroviral therapy.
实验性的:FCC control and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
实验性的:FCC control and High coupon value
The HIV testing coupons distributed to households in this group have higher values.
无干预:FCC control and no info

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Indicator for HIV testing coupon redemption at the household level
大体时间: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.

14 days following the date coupons are distributed to a household.
Indicator for school attendance at the child-level
大体时间: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.

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月1日

初级完成 (实际的)

2021年3月31日

研究完成 (实际的)

2021年6月30日

研究注册日期

首次提交

2019年3月15日

首先提交符合 QC 标准的

2019年3月15日

首次发布 (实际的)

2019年3月19日

研究记录更新

最后更新发布 (实际的)

2021年8月12日

上次提交的符合 QC 标准的更新

2021年8月11日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • HUM00113011
  • AID-OAA-L-12-00001 (其他赠款/资助编号:USAID)
  • AID-OAA-LA-16-0004 (其他赠款/资助编号:USAID)
  • AID391A1500006 (其他赠款/资助编号:USAID)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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