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

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University of Michigan

Status

Completed

Conditions

HIV/AIDS

Treatments

Behavioral: HIV/AIDS and ART Information Combined
Behavioral: Anti Stigma Information
Behavioral: High coupon value
Behavioral: HIV/AIDS Information
Behavioral: ART Information
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary

Study type

Interventional

Funder types

Other

Identifiers

NCT03880175
AID-OAA-L-12-00001 (Other Grant/Funding Number)
AID391A1500006 (Other Grant/Funding Number)
AID-OAA-LA-16-0004 (Other Grant/Funding Number)
HUM00113011

Details and patient eligibility

About

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.

Enrollment

3,658 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

3,658 participants in 18 patient groups

FCC DEB and Anti-stigma
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
Behavioral: Anti Stigma Information
FCC DEB and HIV info
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
Behavioral: HIV/AIDS Information
FCC DEB and ART info
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
Behavioral: ART Information
FCC DEB and HIV-ART info
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
Behavioral: HIV/AIDS and ART Information Combined
FCC DEB and high coupon value
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
Behavioral: High coupon value
FCC DEB and no info
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
FCC non-DEB and Anti-stigma
Experimental group
Treatment:
Behavioral: Anti Stigma Information
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
FCC non-DEB and HIV info
Experimental group
Treatment:
Behavioral: HIV/AIDS Information
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
FCC non-DEB and ART info
Experimental group
Treatment:
Behavioral: ART Information
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
FCC non-DEB and HIV-ART info
Experimental group
Treatment:
Behavioral: HIV/AIDS and ART Information Combined
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
FCC non-DEB and high coupon value
Experimental group
Treatment:
Behavioral: High coupon value
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
FCC non-DEB and no info
Experimental group
Treatment:
Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
FCC control and Anti-stigma
Experimental group
Treatment:
Behavioral: Anti Stigma Information
FCC control and HIV info
Experimental group
Treatment:
Behavioral: HIV/AIDS Information
FCC control and ART info
Experimental group
Treatment:
Behavioral: ART Information
FCC control and HIV-ART info
Experimental group
Treatment:
Behavioral: HIV/AIDS and ART Information Combined
FCC control and High coupon value
Experimental group
Treatment:
Behavioral: High coupon value
FCC control and no info
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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