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

• ClinicalTrials.gov Identifier: NCT03880175
• Recruitment Status: Completed
• First Posted: March 19, 2019
• Last Update Posted: August 12, 2021
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Dean Yang, University of Michigan

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Behavioral: Anti Stigma Information; Behavioral: HIV/AIDS Information; Behavioral: ART Information; Behavioral: HIV/AIDS and ART Information Combined; Behavioral: High coupon value	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3658 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: March 31, 2021
• Actual Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: FCC DEB and Anti-stigma	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Households are directly linked to the FCC implementing organization; Behavioral: Anti Stigma Information; Adults in the households are provided anti-stigma information
Experimental: FCC DEB and HIV info	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Households are directly linked to the FCC implementing organization; Behavioral: HIV/AIDS Information; The households receive information about HIV infection and AIDS
Experimental: FCC DEB and ART info	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Households are directly linked to the FCC implementing organization; Behavioral: ART Information; The households receive information about antiretroviral therapy.
Experimental: FCC DEB and HIV-ART info	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Households are directly linked to the FCC implementing organization; Behavioral: HIV/AIDS and ART Information Combined; The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Experimental: FCC DEB and high coupon value	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Households are directly linked to the FCC implementing organization; Behavioral: High coupon value; The HIV testing coupons distributed to households in this group have higher values.
Experimental: FCC DEB and no info	Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Households are directly linked to the FCC implementing organization
Experimental: FCC non-DEB and Anti-stigma	Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Households live in FCC implementing communities but are not directly linked to the FCC implementing organization; Behavioral: Anti Stigma Information; Adults in the households are provided anti-stigma information
Experimental: FCC non-DEB and HIV info	Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Households live in FCC implementing communities but are not directly linked to the FCC implementing organization; Behavioral: HIV/AIDS Information; The households receive information about HIV infection and AIDS
Experimental: FCC non-DEB and ART info	Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Households live in FCC implementing communities but are not directly linked to the FCC implementing organization; Behavioral: ART Information; The households receive information about antiretroviral therapy.
Experimental: FCC non-DEB and HIV-ART info	Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Households live in FCC implementing communities but are not directly linked to the FCC implementing organization; Behavioral: HIV/AIDS and ART Information Combined; The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Experimental: FCC non-DEB and high coupon value	Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Households live in FCC implementing communities but are not directly linked to the FCC implementing organization; Behavioral: High coupon value; The HIV testing coupons distributed to households in this group have higher values.
Experimental: FCC non-DEB and no info	Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Experimental: FCC control and Anti-stigma	Behavioral: Anti Stigma Information; Adults in the households are provided anti-stigma information
Experimental: FCC control and HIV info	Behavioral: HIV/AIDS Information; The households receive information about HIV infection and AIDS
Experimental: FCC control and ART info	Behavioral: ART Information; The households receive information about antiretroviral therapy.
Experimental: FCC control and HIV-ART info	Behavioral: HIV/AIDS and ART Information Combined; The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Experimental: FCC control and High coupon value	Behavioral: High coupon value; The HIV testing coupons distributed to households in this group have higher values.
No Intervention: FCC control and no info

Outcome Measures

Primary Outcome Measures :

1. Indicator for HIV testing coupon redemption at the household level [ Time Frame: 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.

2. Indicator for school attendance at the child-level [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Mozambique

Lessitala Consultoria e Servicos

Beira, Sofala, Mozambique

Sponsors and Collaborators

University of Michigan

More Information

• Responsible Party: Dean Yang, Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03880175
• Other Study ID Numbers: HUM00113011; AID-OAA-L-12-00001 ( Other Grant/Funding Number: USAID ); AID-OAA-LA-16-0004 ( Other Grant/Funding Number: USAID ); AID391A1500006 ( Other Grant/Funding Number: USAID )
• First Posted: March 19, 2019
• Last Update Posted: August 12, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases