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

11 de agosto de 2021 atualizado por: 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.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

3658

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Sofala
      • Beira, Sofala, Moçambique
        • Lessitala Consultoria e Servicos

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: FCC DEB and Anti-stigma
Households are directly linked to the FCC implementing organization
Adults in the households are provided anti-stigma information
Experimental: FCC DEB and HIV info
Households are directly linked to the FCC implementing organization
The households receive information about HIV infection and AIDS
Experimental: FCC DEB and ART info
Households are directly linked to the FCC implementing organization
The households receive information about antiretroviral therapy.
Experimental: 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.
Experimental: 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.
Experimental: FCC DEB and no info
Households are directly linked to the FCC implementing organization
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: FCC non-DEB and no info
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Experimental: FCC control and Anti-stigma
Adults in the households are provided anti-stigma information
Experimental: FCC control and HIV info
The households receive information about HIV infection and AIDS
Experimental: FCC control and ART info
The households receive information about antiretroviral therapy.
Experimental: FCC control and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Experimental: FCC control and High coupon value
The HIV testing coupons distributed to households in this group have higher values.
Sem intervenção: FCC control and no info

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Indicator for HIV testing coupon redemption at the household level
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2017

Conclusão Primária (Real)

31 de março de 2021

Conclusão do estudo (Real)

30 de junho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

15 de março de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de março de 2019

Primeira postagem (Real)

19 de março de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de agosto de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de agosto de 2021

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HUM00113011
  • AID-OAA-L-12-00001 (Número de outro subsídio/financiamento: USAID)
  • AID-OAA-LA-16-0004 (Número de outro subsídio/financiamento: USAID)
  • AID391A1500006 (Número de outro subsídio/financiamento: USAID)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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