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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.

調査の概要

研究の種類

介入

入学 (実際)

3658

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Sofala
      • Beira、Sofala、モザンビーク
        • Lessitala Consultoria e Servicos

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:階乗代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:FCC DEB and Anti-stigma
Households are directly linked to the FCC implementing organization
Adults in the households are provided anti-stigma information
実験的:FCC DEB and HIV info
Households are directly linked to the FCC implementing organization
The households receive information about HIV infection and AIDS
実験的:FCC DEB and ART info
Households are directly linked to the FCC implementing organization
The households receive information about antiretroviral therapy.
実験的: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.
実験的: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.
実験的:FCC DEB and no info
Households are directly linked to the FCC implementing organization
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
実験的:FCC non-DEB and no info
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
実験的:FCC control and Anti-stigma
Adults in the households are provided anti-stigma information
実験的:FCC control and HIV info
The households receive information about HIV infection and AIDS
実験的:FCC control and ART info
The households receive information about antiretroviral therapy.
実験的:FCC control and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
実験的:FCC control and High coupon value
The HIV testing coupons distributed to households in this group have higher values.
介入なし:FCC control and no info

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Indicator for HIV testing coupon redemption at the household level
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年1月1日

一次修了 (実際)

2021年3月31日

研究の完了 (実際)

2021年6月30日

試験登録日

最初に提出

2019年3月15日

QC基準を満たした最初の提出物

2019年3月15日

最初の投稿 (実際)

2019年3月19日

学習記録の更新

投稿された最後の更新 (実際)

2021年8月12日

QC基準を満たした最後の更新が送信されました

2021年8月11日

最終確認日

2021年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • HUM00113011
  • AID-OAA-L-12-00001 (その他の助成金/資金番号:USAID)
  • AID-OAA-LA-16-0004 (その他の助成金/資金番号:USAID)
  • AID391A1500006 (その他の助成金/資金番号:USAID)

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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