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

keskiviikko 11. elokuuta 2021 päivittänyt: Dean Yang, University of Michigan

Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique

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.

Tutkimuksen yleiskatsaus

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

3658

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Sofala
      • Beira, Sofala, Mosambik
        • Lessitala Consultoria e Servicos

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Tukevaa hoitoa
  • Jako: Satunnaistettu
  • Inventiomalli: Tehtävätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: FCC DEB and Anti-stigma
Households are directly linked to the FCC implementing organization
Adults in the households are provided anti-stigma information
Kokeellinen: FCC DEB and HIV info
Households are directly linked to the FCC implementing organization
The households receive information about HIV infection and AIDS
Kokeellinen: FCC DEB and ART info
Households are directly linked to the FCC implementing organization
The households receive information about antiretroviral therapy.
Kokeellinen: FCC DEB and HIV-ART info
Households are directly linked to the FCC implementing organization
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Kokeellinen: FCC DEB and high coupon value
Households are directly linked to the FCC implementing organization
The HIV testing coupons distributed to households in this group have higher values.
Kokeellinen: FCC DEB and no info
Households are directly linked to the FCC implementing organization
Kokeellinen: FCC non-DEB and Anti-stigma
Adults in the households are provided anti-stigma information
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Kokeellinen: FCC non-DEB and HIV info
The households receive information about HIV infection and AIDS
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Kokeellinen: FCC non-DEB and ART info
The households receive information about antiretroviral therapy.
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Kokeellinen: FCC non-DEB and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Kokeellinen: FCC non-DEB and high coupon value
The HIV testing coupons distributed to households in this group have higher values.
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Kokeellinen: FCC non-DEB and no info
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Kokeellinen: FCC control and Anti-stigma
Adults in the households are provided anti-stigma information
Kokeellinen: FCC control and HIV info
The households receive information about HIV infection and AIDS
Kokeellinen: FCC control and ART info
The households receive information about antiretroviral therapy.
Kokeellinen: FCC control and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Kokeellinen: FCC control and High coupon value
The HIV testing coupons distributed to households in this group have higher values.
Ei väliintuloa: FCC control and no info

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Indicator for HIV testing coupon redemption at the household level
Aikaikkuna: 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.

14 days following the date coupons are distributed to a household.
Indicator for school attendance at the child-level
Aikaikkuna: 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.

The time when the research team is conducting the school visit, which lasts 4 to 8 hours in each school

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Sunnuntai 1. tammikuuta 2017

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 31. maaliskuuta 2021

Opintojen valmistuminen (Todellinen)

Keskiviikko 30. kesäkuuta 2021

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 15. maaliskuuta 2019

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 15. maaliskuuta 2019

Ensimmäinen Lähetetty (Todellinen)

Tiistai 19. maaliskuuta 2019

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 12. elokuuta 2021

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 11. elokuuta 2021

Viimeksi vahvistettu

Sunnuntai 1. elokuuta 2021

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • HUM00113011
  • AID-OAA-L-12-00001 (Muu apuraha/rahoitusnumero: USAID)
  • AID-OAA-LA-16-0004 (Muu apuraha/rahoitusnumero: USAID)
  • AID391A1500006 (Muu apuraha/rahoitusnumero: USAID)

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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