- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02139176
Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.
This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.
Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.
Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Central District
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Lilongwe, Central District, Malaui
- Bwaila District Hospital Antenatal Unit
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
18 years old or 16-17 years old and married
- Pregnant
- Received a positive HIV-test within the last day
- Will be in Lilongwe for the next month
- Able and willing to give locator information for >1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)
Exclusion Criteria:
- Enrolled/enrolling in the PROMISE study
- Initially Presenting with a male sex partner
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Patient referral
Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
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A patient agrees to recruit their partner using the invitation.
Otros nombres:
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Experimental: contract referral
Same as control.
However, if the male partner does not present, a community worker will trace the partner in the community.
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A patient agrees to recruit their partner using the invitation.
Otros nombres:
A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
Periodo de tiempo: three months
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Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake.
We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.
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three months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Female First Option B+ Follow-up Visit
Periodo de tiempo: three months
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It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records).
The number retained will be compared.
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three months
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Male Linkage to Care
Periodo de tiempo: one month from male presentation to the clinic
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It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner.
This will be assessed from abstraction of routine clinic records at Martin Preuss Center.
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one month from male presentation to the clinic
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nora E Rosenberg, PhD, University of North Carolina, Chapel Hill
- Investigador principal: Mina Hosseinipour, MD, University of North Carolina, Chapel Hill
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Palabras clave
Otros números de identificación del estudio
- 13-3707
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. .
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