HIVIzinkanyeziNCT07741474
Community Popular Opinion Leader Intervention for HIV Prevention Uptake in Rural South Africa
A study testing CPOL group training in people with HIV and Sexually Transmitted Infections (STI), run by Africa Health Research Institute at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections (STI)
- What is being tested?
- CPOL group training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2026to Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Resident in Sixhumene study area household
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site
Africa Health Research Institute
uMkhanyakude, KwaZulu-Natal
Guy Harling, ScD
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- HIV, Sexually Transmitted Infections (STI)
- Being tested
- CPOL group training
- Keywords
- pilot, HIV prevention, behavior change, risk communication, HIV self-testing, social networks
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPOL group trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Random selection | Experimental | Invitation to participate in the group training is based on a random selection from all age-eligible individuals in the study area Receives: Behavioral: CPOL group training |
| Nomination | Experimental | Invitation to participate in the group training is based nominations by peers in the study area Receives: Behavioral: CPOL group training |
| Network graph-based | Experimental | 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 Receives: Behavioral: CPOL group training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV self-tests distributed
The mean number of HIV self-tests distributed to peers by trainees
Measured: From enrollment to 4 weeks after last training session
Secondary outcomes (6)
Number of peer conversations held
Mean number of conversations trainees report holding with peers
Measured: Enrollemnt to 4 weeks after last training session
Trainee HIV ART knowledge improvement
Mean change in scores pre/post intervention on a 5-item ART knowledge question set [range 0-5; higher = better]
Measured: Enrollment to end of last session (4 week period)
Trainee HIV PrEP knowledge improvement
Mean change in scores pre/post intervention on a 5-item PrEP knowledge question set [range 0-5; higher = better]
Measured: Enrollment to end of last session (4 week period)
Trainee generalized self-efficacy improvement
Mean change in scores pre/post intervention on the Generalized Self Efficacy-short form (GSE 6) scale [range 6-24; higher = better]
Measured: Enrollment to end of last session (4 week period)
Trainee ART/PrEP self-efficacy improvement
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]
Measured: Enrollment to end of last session (4 week period)
Trainee ART/PrEP stigma reduction
Mean change in scores pre/post intervention on a 6-item ART/PrEP use stigma question set [range 6-24; higher = worse]
Measured: Enrollment to end of last session (4 week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Selection from the population to participate in the intervention is conducted using different methods in each study arm, each defined by a geographic location. Methods are applied to locations at random.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Africa Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741474
- Sponsor's protocol ID
- A0006-7968/2024
- Acronym
- Izinkanyezi
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.
Publications
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.
PubMed 18445795Nxumalo 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.
PubMed 36324699