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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
FCC (Força à Comunidade e Crianças) program- direct beneficiary
FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
Anti Stigma Information
HIV/AIDS Information
ART Information
HIV/AIDS and ART Information Combined
High coupon value
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Lessitala Consultoria e Servicos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

FCC DEB and Anti-stigma

FCC DEB and HIV info

FCC DEB and ART info

FCC DEB and HIV-ART info

FCC DEB and high coupon value

FCC DEB and no info

FCC non-DEB and Anti-stigma

FCC non-DEB and HIV info

FCC non-DEB and ART info

FCC non-DEB and HIV-ART info

FCC non-DEB and high coupon value

FCC non-DEB and no info

FCC control and Anti-stigma

FCC control and HIV info

FCC control and ART info

FCC control and HIV-ART info

FCC control and High coupon value

FCC control and no info

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2019
Last Updated
August 11, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03880175
Brief Title
Direct and Spillover Impacts of a Community-Level HIV/AIDS Program
Acronym
FCC
Official Title
Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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

5. 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3658 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FCC DEB and Anti-stigma
Arm Type
Experimental
Arm Title
FCC DEB and HIV info
Arm Type
Experimental
Arm Title
FCC DEB and ART info
Arm Type
Experimental
Arm Title
FCC DEB and HIV-ART info
Arm Type
Experimental
Arm Title
FCC DEB and high coupon value
Arm Type
Experimental
Arm Title
FCC DEB and no info
Arm Type
Experimental
Arm Title
FCC non-DEB and Anti-stigma
Arm Type
Experimental
Arm Title
FCC non-DEB and HIV info
Arm Type
Experimental
Arm Title
FCC non-DEB and ART info
Arm Type
Experimental
Arm Title
FCC non-DEB and HIV-ART info
Arm Type
Experimental
Arm Title
FCC non-DEB and high coupon value
Arm Type
Experimental
Arm Title
FCC non-DEB and no info
Arm Type
Experimental
Arm Title
FCC control and Anti-stigma
Arm Type
Experimental
Arm Title
FCC control and HIV info
Arm Type
Experimental
Arm Title
FCC control and ART info
Arm Type
Experimental
Arm Title
FCC control and HIV-ART info
Arm Type
Experimental
Arm Title
FCC control and High coupon value
Arm Type
Experimental
Arm Title
FCC control and no info
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
FCC (Força à Comunidade e Crianças) program- direct beneficiary
Intervention Description
Households are directly linked to the FCC implementing organization
Intervention Type
Behavioral
Intervention Name(s)
FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
Intervention Description
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Intervention Type
Behavioral
Intervention Name(s)
Anti Stigma Information
Intervention Description
Adults in the households are provided anti-stigma information
Intervention Type
Behavioral
Intervention Name(s)
HIV/AIDS Information
Intervention Description
The households receive information about HIV infection and AIDS
Intervention Type
Behavioral
Intervention Name(s)
ART Information
Intervention Description
The households receive information about antiretroviral therapy.
Intervention Type
Behavioral
Intervention Name(s)
HIV/AIDS and ART Information Combined
Intervention Description
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Intervention Type
Behavioral
Intervention Name(s)
High coupon value
Intervention Description
The HIV testing coupons distributed to households in this group have higher values.
Primary Outcome Measure Information:
Title
Indicator for HIV testing coupon redemption at the household level
Description
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.
Time Frame
14 days following the date coupons are distributed to a household.
Title
Indicator for school attendance at the child-level
Description
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.
Time Frame
The time when the research team is conducting the school visit, which lasts 4 to 8 hours in each school

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Lessitala Consultoria e Servicos
City
Beira
State/Province
Sofala
Country
Mozambique

12. IPD Sharing Statement

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

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