Direct and Spillover Impacts of a Community-Level HIV/AIDS Program
FCC
4 other identifiers
interventional
3,658
1 country
1
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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 12, 2021
August 1, 2021
4.2 years
March 15, 2019
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Indicator for HIV testing coupon redemption at the household level
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
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
Study Arms (18)
FCC DEB and Anti-stigma
EXPERIMENTALFCC DEB and HIV info
EXPERIMENTALFCC DEB and ART info
EXPERIMENTALFCC DEB and HIV-ART info
EXPERIMENTALFCC DEB and high coupon value
EXPERIMENTALFCC DEB and no info
EXPERIMENTALFCC non-DEB and Anti-stigma
EXPERIMENTALFCC non-DEB and HIV info
EXPERIMENTALFCC non-DEB and ART info
EXPERIMENTALFCC non-DEB and HIV-ART info
EXPERIMENTALFCC non-DEB and high coupon value
EXPERIMENTALFCC non-DEB and no info
EXPERIMENTALFCC control and Anti-stigma
EXPERIMENTALFCC control and HIV info
EXPERIMENTALFCC control and ART info
EXPERIMENTALFCC control and HIV-ART info
EXPERIMENTALFCC control and High coupon value
EXPERIMENTALFCC control and no info
NO INTERVENTIONInterventions
Households are directly linked to the FCC implementing organization
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Adults in the households are provided anti-stigma information
The households receive information about HIV infection and AIDS
The households receive information about antiretroviral therapy.
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
The HIV testing coupons distributed to households in this group have higher values.
Eligibility Criteria
You may qualify if:
- Households that lives in one of the eligible communities.
You may not qualify if:
- Households that are not in the eligible communities will not be included in the survey sample.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lessitala Consultoria e Servicos
Beira, Sofala, Mozambique
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2019
First Posted
March 19, 2019
Study Start
January 1, 2017
Primary Completion
March 31, 2021
Study Completion
June 30, 2021
Last Updated
August 12, 2021
Record last verified: 2021-08