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

11 de agosto de 2021 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

3658

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: FCC DEB and Anti-stigma
Households are directly linked to the FCC implementing organization
Adults in the households are provided anti-stigma information
Experimental: FCC DEB and HIV info
Households are directly linked to the FCC implementing organization
The households receive information about HIV infection and AIDS
Experimental: FCC DEB and ART info
Households are directly linked to the FCC implementing organization
The households receive information about antiretroviral therapy.
Experimental: 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.
Experimental: 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.
Experimental: FCC DEB and no info
Households are directly linked to the FCC implementing organization
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: FCC non-DEB and no info
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Experimental: FCC control and Anti-stigma
Adults in the households are provided anti-stigma information
Experimental: FCC control and HIV info
The households receive information about HIV infection and AIDS
Experimental: FCC control and ART info
The households receive information about antiretroviral therapy.
Experimental: FCC control and HIV-ART info
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
Experimental: FCC control and High coupon value
The HIV testing coupons distributed to households in this group have higher values.
Sin intervención: FCC control and no info

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Indicator for HIV testing coupon redemption at the household level
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2017

Finalización primaria (Actual)

31 de marzo de 2021

Finalización del estudio (Actual)

30 de junio de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de marzo de 2019

Primero enviado que cumplió con los criterios de control de calidad

15 de marzo de 2019

Publicado por primera vez (Actual)

19 de marzo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HUM00113011
  • AID-OAA-L-12-00001 (Otro número de subvención/financiamiento: USAID)
  • AID-OAA-LA-16-0004 (Otro número de subvención/financiamiento: USAID)
  • AID391A1500006 (Otro número de subvención/financiamiento: USAID)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre VIH/SIDA

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