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Community Popular Opinion Leader Intervention for HIV Prevention Uptake in Rural South Africa (Izinkanyezi)

30 de julho de 2026 atualizado 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).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • África do Sul
    • KwaZulu-Natal
      • uMkhanyakude, KwaZulu-Natal, África do Sul
        • Africa Health Research Institute
        • Investigador principal:
          • Guy Harling, ScD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Resident in Sixhumene study area household

Exclusion Criteria:

  • Unable to provide informed consent

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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
Comportamental: CPOL group training
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.
Experimental: Nomination
Invitation to participate in the group training is based nominations by peers in the study area
Comportamental: CPOL group training
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.
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
Comportamental: CPOL group training
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of HIV self-tests distributed
Prazo: From enrollment to 4 weeks after last training session
The mean number of HIV self-tests distributed to peers by trainees
From enrollment to 4 weeks after last training session

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of peer conversations held
Prazo: Enrollemnt to 4 weeks after last training session
Mean number of conversations trainees report holding with peers
Enrollemnt to 4 weeks after last training session
Trainee HIV ART knowledge improvement
Prazo: Enrollment to end of last session (4 week period)
Mean change in scores pre/post intervention on a 5-item ART knowledge question set [range 0-5; higher = better]
Enrollment to end of last session (4 week period)
Trainee HIV PrEP knowledge improvement
Prazo: Enrollment to end of last session (4 week period)
Mean change in scores pre/post intervention on a 5-item PrEP knowledge question set [range 0-5; higher = better]
Enrollment to end of last session (4 week period)
Trainee generalized self-efficacy improvement
Prazo: Enrollment to end of last session (4 week period)
Mean change in scores pre/post intervention on the Generalized Self Efficacy-short form (GSE 6) scale [range 6-24; higher = better]
Enrollment to end of last session (4 week period)
Trainee ART/PrEP self-efficacy improvement
Prazo: Enrollment to end of last session (4 week period)
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]
Enrollment to end of last session (4 week period)
Trainee ART/PrEP stigma reduction
Prazo: Enrollment to end of last session (4 week period)
Mean change in scores pre/post intervention on a 6-item ART/PrEP use stigma question set [range 6-24; higher = worse]
Enrollment to end of last session (4 week period)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions
Prazo: Enrollment to 4 weeks after last training session
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.
Enrollment to 4 weeks after last training session
Trainee Confidence in Conducting Peer Conversations Assessed Through Semi-Structured Interviews and Focus Group Discussions
Prazo: Enrollment to 12 weeks after last training session
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.
Enrollment to 12 weeks after last training session
Facilitators and Barriers to Peer Conversations Assessed Through Semi-Structured Interviews and Focus Group Discussions
Prazo: Enrollment to 12 weeks after last training session
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.
Enrollment to 12 weeks after last training session
Perceptions of the Training Programme Assessed Through Semi-Structured Interviews and Focus Group Discussions
Prazo: Enrollment to 12 weeks after last training session
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.
Enrollment to 12 weeks after last training session
Intervention Adaptations Assessed Through Semi-Structured Interviews and Focus Group Discussions
Prazo: Enrollment to 12 weeks after last training session
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.
Enrollment to 12 weeks after last training session

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Africa Health Research Institute

Colaboradores

University College, London

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de julho de 2026

Primeira postagem (Real)

3 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A0006-7968/2024

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • CIF
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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