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

30 luglio 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Sud Africa
    • KwaZulu-Natal
      • uMkhanyakude, KwaZulu-Natal, Sud Africa
        • Africa Health Research Institute
        • Investigatore principale:
          • Guy Harling, ScD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Resident in Sixhumene study area household

Exclusion Criteria:

  • Unable to provide informed consent

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Random selection
Invitation to participate in the group training is based on a random selection from all age-eligible individuals in the study area
Comportamentale: 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.
Sperimentale: Nomination
Invitation to participate in the group training is based nominations by peers in the study area
Comportamentale: 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.
Sperimentale: 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
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of HIV self-tests distributed
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of peer conversations held
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Africa Health Research Institute

Collaboratori

University College, London

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

21 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 luglio 2026

Primo Inserito (Effettivo)

3 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A0006-7968/2024

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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