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NCT Number: NCT07741474

Community Popular Opinion Leader Intervention for HIV Prevention Uptake 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).

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Key information

Conditions

HIV Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Infections (STI) Urogenital Diseases

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Africa Health Research Institute

uMkhanyakude, KwaZulu-Natal, South Africa

Location contact

Guy Harling, ScD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resident in Sixhumene study area household

Exclusion criteria

  • Unable to provide informed consent

Treatment and study plan

CPOL group training

Behavioral

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.

Primary outcomes

  1. Number of HIV self-tests distributed

    Time frame: From enrollment to 4 weeks after last training session

    The mean number of HIV self-tests distributed to peers by trainees

Secondary outcomes

  1. Number of peer conversations held

    Time frame: Enrollemnt to 4 weeks after last training session

    Mean number of conversations trainees report holding with peers

  2. Trainee HIV ART knowledge improvement

    Time frame: 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]

  3. Trainee HIV PrEP knowledge improvement

    Time frame: 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]

  4. Trainee generalized self-efficacy improvement

    Time frame: 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]

  5. Trainee ART/PrEP self-efficacy improvement

    Time frame: 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]

  6. Trainee ART/PrEP stigma reduction

    Time frame: 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]

Other outcomes

  1. Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions

    Time frame: 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.

  2. Trainee Confidence in Conducting Peer Conversations Assessed Through Semi-Structured Interviews and Focus Group Discussions

    Time frame: 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.

  3. Facilitators and Barriers to Peer Conversations Assessed Through Semi-Structured Interviews and Focus Group Discussions

    Time frame: 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.

  4. Perceptions of the Training Programme Assessed Through Semi-Structured Interviews and Focus Group Discussions

    Time frame: 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.

  5. Intervention Adaptations Assessed Through Semi-Structured Interviews and Focus Group Discussions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guy Harling, ScD

CONTACT

[email protected]

+27352510650

Sponsors and collaborators

Lead sponsor

Africa Health Research Institute

Other

Collaborators

  • University College, London

Registry information

Official study title

Adapting and Piloting a Community Popular Opinion Leader Intervention to Increase Uptake of HIV Prevention Interventions in Rural South Africa

Acronym: Izinkanyezi

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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