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

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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

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Direct and Spillover Impacts of a Community-Level HIV/AIDS Program
Official Title  ICMJE Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
    Households are directly linked to the FCC implementing organization
  • 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
  • Behavioral: HIV/AIDS Information
    The households receive information about HIV infection and AIDS
  • Behavioral: ART Information
    The households receive information about antiretroviral therapy.
  • Behavioral: HIV/AIDS and ART Information Combined
    The households receive both information about HIV/AIDS and information about antiretroviral therapy.
  • Behavioral: High coupon value
    The HIV testing coupons distributed to households in this group have higher values.
Study Arms  ICMJE
  • Experimental: FCC DEB and Anti-stigma
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
    • Behavioral: Anti Stigma Information
  • Experimental: FCC DEB and HIV info
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
    • Behavioral: HIV/AIDS Information
  • Experimental: FCC DEB and ART info
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
    • Behavioral: ART Information
  • Experimental: FCC DEB and HIV-ART info
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
    • Behavioral: HIV/AIDS and ART Information Combined
  • Experimental: FCC DEB and high coupon value
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
    • Behavioral: High coupon value
  • Experimental: FCC DEB and no info
    Intervention: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary
  • Experimental: FCC non-DEB and Anti-stigma
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
    • Behavioral: Anti Stigma Information
  • Experimental: FCC non-DEB and HIV info
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
    • Behavioral: HIV/AIDS Information
  • Experimental: FCC non-DEB and ART info
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
    • Behavioral: ART Information
  • Experimental: FCC non-DEB and HIV-ART info
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
    • Behavioral: HIV/AIDS and ART Information Combined
  • Experimental: FCC non-DEB and high coupon value
    Interventions:
    • Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
    • Behavioral: High coupon value
  • Experimental: FCC non-DEB and no info
    Intervention: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
  • Experimental: FCC control and Anti-stigma
    Intervention: Behavioral: Anti Stigma Information
  • Experimental: FCC control and HIV info
    Intervention: Behavioral: HIV/AIDS Information
  • Experimental: FCC control and ART info
    Intervention: Behavioral: ART Information
  • Experimental: FCC control and HIV-ART info
    Intervention: Behavioral: HIV/AIDS and ART Information Combined
  • Experimental: FCC control and High coupon value
    Intervention: Behavioral: High coupon value
  • No Intervention: FCC control and no info
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
25000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Faustino Lessitala, Master +258821538453 faustinolessitala81@gmail.com
Listed Location Countries  ICMJE Mozambique
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880175
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dean Yang, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP