Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880175
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dean Yang, University of Michigan

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25000 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
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880175


Contacts
Layout table for location contacts
Contact: Faustino Lessitala, Master +258821538453 faustinolessitala81@gmail.com

Locations
Layout table for location information
Mozambique
Lessitala Consultoria e Servicos Recruiting
Beira, Sofala, Mozambique
Contact: Faustino Lessitala    +258821538453    faustinolessitala81@gmail.com   
Sponsors and Collaborators
University of Michigan

Layout table for additonal information
Responsible Party: Dean Yang, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03880175     History of Changes
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    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No