- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03880175
Direct and Spillover Impacts of a Community-Level HIV/AIDS Program (FCC)
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:
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Conductual: FCC (Força à Comunidade e Crianças) program- direct beneficiary
- Conductual: Anti Stigma Information
- Conductual: HIV/AIDS Information
- Conductual: ART Information
- Conductual: HIV/AIDS and ART Information Combined
- Conductual: High coupon value
- Conductual: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sofala
-
Beira, Sofala, Mozambique
- Lessitala Consultoria e Servicos
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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