Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

27 de mayo de 2020 actualizado por: RAND

Game Changers: Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

This randomized controlled pilot study of the "Game Changers" program will:

  1. Assess the feasibility and acceptability of implementing an HIV prevention advocacy intervention with people living with HIV who are in HIV care, and who will be trained to be advocates of HIV protective behaviors within their social networks.
  2. Assess preliminary intervention effects on a) protective behavior of the HIV-positive clients (condom use, partner concurrency/number of partners, engagement in HIV care, ART adherence); and b) diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma.
  3. Explore characteristics of HIV-positive clients who more effectively engage in prevention advocacy (in terms of socio-demographics, network characteristics, and network position and type of alters receiving advocacy).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

People living with HIV (PLWH) have a critical role to play in HIV prevention, not only in the context of Prevention for Positives and Treatment as Prevention, but as powerful change agents for HIV protective behaviors among others. Our research suggests that as PLWH receive HIV treatment and restore their health and functioning, many are motivated to protect their loved ones and engage in prevention advocacy (i.e., to encourage friends and family to seek HIV testing and treatment, and to reduce risk behavior); however, the quality of this advocacy is hampered by challenges related to message content, style and timing of delivery, and selection of advocacy recipients. With effective advocacy training, mobilizing PLWH to be change agents within their social networks has the potential to be a "game changer" for HIV prevention, particularly in high prevalence settings such as Uganda, where virtually every family is touched by someone living with HIV. Drawing upon theoretical frameworks for network-based interventions, such as theories of social diffusion, cognitive consistency, and social influence, the proposed study will develop and pilot test "Game Changers"-- an intervention that aims to empower and mobilize PLWH to be agents for HIV prevention and behavioral change in their social networks. In Phase 1, separate focus groups of PLWH and members of their social networks (family and friends) were conducted to explore barriers to and facilitators of mobilizing clients to advocate for HIV prevention, perceptions on how advocacy could be most effective in motivating behavior change, and how to best structure the intervention and its content. In Phase 2 findings from Phase 1 and network-based intervention models were used to develop the structure and content of an intervention designed to help clients cope with stigma, manage their disease, live positively, and develop motivation and skills for HIV disclosure and prevention advocacy. In Phase 3 a pilot group intervention will be conducted in a controlled trial of 96 clients, with 48 randomly assigned to receive the intervention and 48 to the wait-list control. Assessments will be administered to all participants at baseline, 5 months later, and again 8 months after baseline, after which the control group will receive the intervention (but not the interviews). PLWH interviews and social network assessments will examine intervention effects on protective behaviors of the participant (condom use, HIV treatment adherence), and diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma. At the end of the intervention period a focus group with program participants will be conducted to get feedback on the intervention. To help understand how participation in the program might affect health, date of HIV diagnosis, last two CD4 counts and HIV viral loads, and prescribed HIV medications will be obtained from PLWH participant medical charts. Participants (about 15/arm) will be asked to recruit up to 3 alters each, who know the participant's serostatus, to be interviewed to assess their HIV protective behaviors (e.g., condom use) and receipt of prevention advocacy from the intervention participant.

Tipo de estudio

Intervencionista

Inscripción (Actual)

99

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

      • Kampala, Uganda
        • Infectious Diseases Institute

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria (People living with HIV):

  • 18+ years old
  • In HIV care for > 1 year
  • Having disclosed serostatus to at least one person

Inclusion Criteria (Social network members):

  • 18+ years old
  • Referred by a patient participant because they are family members, friends, or other people in patients' social network
  • knows patient participant's serostatus

Exclusion Criteria:

  • Individuals who meet the inclusion criteria above will be eligible to participate, and no other exclusion criteria apply.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Game Changers Intervention
Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.
Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks.
Sin intervención: Control
The control group will receive standard of care during the intervention assessment period. All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Engagement HIV Prevention Advocacy
Periodo de tiempo: Past 3 months, measured at baseline and 5 and 8 months post-baseline
Self-reported communication with social network members about protective behaviors. This is a composite of 14 survey items rated on a scale of 1 (low level of communication) to 5 (high level of communication).
Past 3 months, measured at baseline and 5 and 8 months post-baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Sexual Risk Behavior Among Alters
Periodo de tiempo: Measured at baseline and 5 and 8 months post-baseline
Increased percentage of self-reported condom use with main partner in past 3 months
Measured at baseline and 5 and 8 months post-baseline
Change in HIV Treatment Adherence
Periodo de tiempo: Measured at baseline and 5 and 8 months post-baseline
Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
Measured at baseline and 5 and 8 months post-baseline
Change in Internalized HIV Stigma
Periodo de tiempo: Measured at baseline and 5 and 8 months post-baseline
Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma)
Measured at baseline and 5 and 8 months post-baseline
Number of Participants Who Have Reported Their HIV Status to Their Main Partner
Periodo de tiempo: Measured at baseline and 5 and 8 months post-baseline
Increased self-reported rates of HIV status disclosure: Participants were asked if they had disclosed their HIV-serostatus to their main partner or spouse (yes/no).
Measured at baseline and 5 and 8 months post-baseline

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)

16 de abril de 2018

Finalización primaria (Actual)

31 de julio de 2019

Finalización del estudio (Actual)

31 de julio de 2019

Fechas de registro del estudio

Enviado por primera vez

8 de febrero de 2018

Primero enviado que cumplió con los criterios de control de calidad

14 de febrero de 2018

Publicado por primera vez (Actual)

19 de febrero de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2020

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

27 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R34MH111460 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

Ensayos clínicos sobre Game Changers

Suscribir