Community Popular Opinion Leader Intervention for HIV Prevention Uptake in Rural South Africa (Izinkanyezi)
30 de julio de 2026 actualizado por: Africa Health Research Institute
Adapting and Piloting a Community Popular Opinion Leader Intervention to Increase Uptake of HIV Prevention Interventions in Rural South Africa
The Community Popular Opinion Leader (CPOL) is an intervention dveloped in the United States which identifies, trains, and enlists key opinion leaders within communities to deliver messages to peers and help link them to services.
This project involves testing the feasibility and acceptability of such a localized version of the CPOL intervention in rural South Africa.
This will be achieved through a pilot intervention in three purposively selected communities in the Hlabisa sub-district of uMkhanyakude district, KwaZulu-Natal.
The investigators will select potential peer leaders in three ways (at random; based on nominations by peers; based on statistical analysis of previously collected social network data).
Peer leaders will be invited to attend four weekly training sessions to learn about HIV prevention and persuasive communication.
They will then be coached to start HIV prevention conversations with peers, including provision of HIV self-test kits and linkage to healthcare services.
The investigators will evaluate this pilot using group discussions, in-depth interviews and brief pre/post questionnaires with session facilitators, peer leaders, contacted peers and healthcare providers.
The investigators will analyse the data collected with the Practical, Robust Implementation and Sustainability Model (PRISM) dissemination and implementation framework, identifying factors likely to affect Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM).
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The CPOL intervention is a local adaptation of an intervention package developed with Black men-who-have-sex-with-men (MSM) in the United States. This pilot trial studies both the overall effectiveness of this adapated intervention in rural South Africa, and the differential benefit of selecting participants using three different methods: 1) at random; 2) based on peer nominations of local opinion leaders; 3) based on a community-wide social network built from nominations of important social contacts. While the primary outcome is quantitative, the study is not powered to see statistically significant differences between arms. The evaluation focus of the pilot trial is the process evaluation, which will follow the RE-AIM framework to assess how and why the intervention worked, failed or needed adjustment. The end result will be a CPOL-style intervention package that may (or may not) be appropriate for rural South Africa, and a methodology for adapting CPOL packages for other sexual health contexts.
The process evaluation will include qualitative group and in-depth one-to-one interviews with: (i) session trainers; (ii) POL trainees; (iii) peers in the local community; (iii) HIV service providers. It will also include a short pre/post questionnaire for all trainees to capture key knowledge and attitude outcomes relating to the training.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
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.
Estudio Contacto
- Nombre: Guy Harling, ScD
- Número de teléfono: +27352510650
- Correo electrónico: guy.harling@ahri.org
Ubicaciones de estudio
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KwaZulu-Natal
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uMkhanyakude, KwaZulu-Natal, Sudáfrica
- Africa Health Research Institute
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Investigador principal:
- Guy Harling, ScD
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Resident in Sixhumene study area household
Exclusion Criteria:
- Unable to provide informed consent
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 |
|---|---|
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Experimental: Random selection
Invitation to participate in the group training is based on a random selection from all age-eligible individuals in the study area
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Trained research assistants will deliver four two-hour training sessions to a group of ~20 young adults, leading to the trainees providing sexual health information and HIV self-tests (with onward self-referral to local clinics) to their friends and close contacts.
Sessions include training on local sexual health information, effective communication strategies, practice conversations and feedback.
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Experimental: Nomination
Invitation to participate in the group training is based nominations by peers in the study area
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Trained research assistants will deliver four two-hour training sessions to a group of ~20 young adults, leading to the trainees providing sexual health information and HIV self-tests (with onward self-referral to local clinics) to their friends and close contacts.
Sessions include training on local sexual health information, effective communication strategies, practice conversations and feedback.
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Experimental: Network graph-based
Invitation to participate in the group training is based centrality within a community-wide social network map built from a survey in the study area
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Trained research assistants will deliver four two-hour training sessions to a group of ~20 young adults, leading to the trainees providing sexual health information and HIV self-tests (with onward self-referral to local clinics) to their friends and close contacts.
Sessions include training on local sexual health information, effective communication strategies, practice conversations and feedback.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of HIV self-tests distributed
Periodo de tiempo: From enrollment to 4 weeks after last training session
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The mean number of HIV self-tests distributed to peers by trainees
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From enrollment to 4 weeks after last training session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of peer conversations held
Periodo de tiempo: Enrollemnt to 4 weeks after last training session
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Mean number of conversations trainees report holding with peers
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Enrollemnt to 4 weeks after last training session
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Trainee HIV ART knowledge improvement
Periodo de tiempo: Enrollment to end of last session (4 week period)
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Mean change in scores pre/post intervention on a 5-item ART knowledge question set [range 0-5; higher = better]
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Enrollment to end of last session (4 week period)
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Trainee HIV PrEP knowledge improvement
Periodo de tiempo: Enrollment to end of last session (4 week period)
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Mean change in scores pre/post intervention on a 5-item PrEP knowledge question set [range 0-5; higher = better]
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Enrollment to end of last session (4 week period)
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Trainee generalized self-efficacy improvement
Periodo de tiempo: Enrollment to end of last session (4 week period)
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Mean change in scores pre/post intervention on the Generalized Self Efficacy-short form (GSE 6) scale [range 6-24; higher = better]
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Enrollment to end of last session (4 week period)
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Trainee ART/PrEP self-efficacy improvement
Periodo de tiempo: Enrollment to end of last session (4 week period)
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Mean change in scores pre/post intervention on a 4-item self-efficacy-short form scale specific to ART and PrEP use [range 4-16; higher = better]
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Enrollment to end of last session (4 week period)
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Trainee ART/PrEP stigma reduction
Periodo de tiempo: Enrollment to end of last session (4 week period)
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Mean change in scores pre/post intervention on a 6-item ART/PrEP use stigma question set [range 6-24; higher = worse]
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Enrollment to end of last session (4 week period)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions
Periodo de tiempo: Enrollment to 4 weeks after last training session
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Process evaluation of participant engagement using qualitative methods.
Data will be collected through semi-structured in-depth interviews and focus group discussions with trainees and peers.
Qualitative thematic analysis will be used to identify barriers and facilitators to engagement, participation, and intervention reach.
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Enrollment to 4 weeks after last training session
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Trainee Confidence in Conducting Peer Conversations Assessed Through Semi-Structured Interviews and Focus Group Discussions
Periodo de tiempo: Enrollment to 12 weeks after last training session
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Process evaluation outcome assessed through semi-structured in-depth interviews and focus group discussions with trainees.
Qualitative thematic analysis will explore participants' confidence in initiating and conducting peer conversations following the training programme.
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Enrollment to 12 weeks after last training session
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Facilitators and Barriers to Peer Conversations Assessed Through Semi-Structured Interviews and Focus Group Discussions
Periodo de tiempo: Enrollment to 12 weeks after last training session
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Process evaluation outcome assessed through semi-structured in-depth interviews and focus group discussions with trainees.
Qualitative thematic analysis will identify perceived facilitators and barriers influencing the conduct of peer conversations.
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Enrollment to 12 weeks after last training session
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Perceptions of the Training Programme Assessed Through Semi-Structured Interviews and Focus Group Discussions
Periodo de tiempo: Enrollment to 12 weeks after last training session
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Process evaluation outcome assessed through semi-structured in-depth interviews and focus group discussions with trainees and trainers.
Qualitative thematic analysis will explore acceptability, perceived value, strengths, and limitations of the training programme.
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Enrollment to 12 weeks after last training session
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Intervention Adaptations Assessed Through Semi-Structured Interviews and Focus Group Discussions
Periodo de tiempo: Enrollment to 12 weeks after last training session
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Process evaluation outcome assessed through semi-structured in-depth interviews and focus group discussions with trainees and trainers.
Qualitative thematic analysis will identify the types of adaptations made during trial implementation and the reasons for these adaptations at both individual and programme levels.
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Enrollment to 12 weeks after last training session
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Jones KT, Gray P, Whiteside YO, Wang T, Bost D, Dunbar E, Foust E, Johnson WD. Evaluation of an HIV prevention intervention adapted for Black men who have sex with men. Am J Public Health. 2008 Jun;98(6):1043-50. doi: 10.2105/AJPH.2007.120337. Epub 2008 Apr 29.
- Nxumalo V, Nxumalo S, Smit T, Khoza T, Mdaba F, Khumalo T, Cislaghi B, McGrath N, Seeley J, Shahmanesh M, Harling G. Protocol: Mapping social networks, social influence and sexual health among youth in rural KwaZulu-Natal, the Sixhumene cohort study. Wellcome Open Res. 2022 May 26;7:164. doi: 10.12688/wellcomeopenres.17896.1. eCollection 2022.
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 (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de octubre de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A0006-7968/2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.
Marco de tiempo para compartir IPD
Data will be available once the primary paper analysing the feasbility trial is complete and accepted for publication.
The data will be available in perpetuity.
Criterios de acceso compartido de IPD
The PI and AHRI data guardian will be responsible for overseeing requests for data sharing and that the researchers granted access to the data comply with the terms of the data sharing agreement, which will include honouring any commitments about the use of the data that have been made to participants at the time they granted consent.
Researchers will be required to acknowledge the source of the data.
The terms will also prohibit researchers attempting to identify participants of the study.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- CÓDIGO_ANALÍTICO
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. .