Community Popular Opinion Leader Intervention for HIV Prevention Uptake in Rural South Africa (Izinkanyezi)
30 juillet 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Guy Harling, ScD
- Numéro de téléphone: +27352510650
- E-mail: guy.harling@ahri.org
Lieux d'étude
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KwaZulu-Natal
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uMkhanyakude, KwaZulu-Natal, Afrique du Sud
- Africa Health Research Institute
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Chercheur principal:
- Guy Harling, ScD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Resident in Sixhumene study area household
Exclusion Criteria:
- Unable to provide informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of HIV self-tests distributed
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of peer conversations held
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 octobre 2026
Achèvement de l'étude (Estimé)
1 octobre 2026
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
30 juillet 2026
Première publication (Réel)
3 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A0006-7968/2024
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.
Délai de partage 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.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .