ClinicalTrials.gg
Not yet recruitingNCT07741474IzinkanyeziUpdated Aug 3, 2026

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

An interventional study of CPOL group training in HIV and Sexually Transmitted Infections (STI), sponsored by Africa Health Research Institute. Not yet recruiting at 1 site in South Africa. Open to participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Africa Health Research Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 28 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in Sexually Transmitted Diseases with a site in South Africa — 2 open to participants now, 3 under way, 1 of them phase 3. Sexually Transmitted Diseases · South Africa.

Planned enrollment
25th of 27
60 · median 564
Started
2026
the only one that year
No phase
15 of 30
2 open now
Registered
30th of 30
by date
Lead sponsor
2 of 30
Africa Health Research Institute

Among the 30 studies in Sexually Transmitted Diseases with a site in South Africa, this one is the 25th largest by planned enrollment of the 27 interventional ones that give a count, is the only one that started in 2026, is one of 15 with no phase, and was the 30th registered.

Sexually Transmitted Diseases

523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.

Browse Sexually Transmitted Diseases studies →

Open to participants now

2 of the 30 studies in Sexually Transmitted Diseases with a site in South Africa are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in South Africa have not opened yet or have stopped. Only those recruiting at a site in South Africa →

Who these studies take

Of the 47 Sexually Transmitted Diseases studies recruiting now, 29 (62%) set no upper age limit and 16 (34%) stop at 75 or younger; 22 take children under 18; 33 take healthy volunteers.

This study: 18 Years to 28 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Sexually Transmitted Diseases with a site in South Africa, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • HIV
  • Sexually Transmitted Infections (STI)

Keywords

  • pilot
  • HIV prevention
  • behavior change
  • risk communication
  • HIV self-testing
  • social networks
04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Resident in Sixhumene study area household

Exclusion criteria

Exclusion Criteria:

  • Unable to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

    Behavioral: CPOL group training

  • Experimental
    Nomination

    Invitation to participate in the group training is based nominations by peers in the study area

    Behavioral: CPOL group training

  • 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

    Behavioral: CPOL group training

Interventions

  • BehavioralCPOL 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.

06

What researchers measure

Primary outcomes

  1. Number of HIV self-tests distributed

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

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

Secondary outcomes

  1. Number of peer conversations held

    Mean number of conversations trainees report holding with peers

    Time frame: Enrollemnt to 4 weeks after last training session

  2. Trainee HIV ART knowledge improvement

    Mean change in scores pre/post intervention on a 5-item ART knowledge question set \[range 0-5; higher = better\]

    Time frame: Enrollment to end of last session (4 week period)

  3. Trainee HIV PrEP knowledge improvement

    Mean change in scores pre/post intervention on a 5-item PrEP knowledge question set \[range 0-5; higher = better\]

    Time frame: Enrollment to end of last session (4 week period)

  4. Trainee generalized self-efficacy improvement

    Mean change in scores pre/post intervention on the Generalized Self Efficacy-short form (GSE 6) scale \[range 6-24; higher = better\]

    Time frame: Enrollment to end of last session (4 week period)

  5. 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 \[range 4-16; higher = better\]

    Time frame: Enrollment to end of last session (4 week period)

  6. Trainee ART/PrEP stigma reduction

    Mean change in scores pre/post intervention on a 6-item ART/PrEP use stigma question set \[range 6-24; higher = worse\]

    Time frame: Enrollment to end of last session (4 week period)

Other outcomes

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

    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.

    Time frame: Enrollment to 4 weeks after last training session

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

    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.

    Time frame: Enrollment to 12 weeks after last training session

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

    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.

    Time frame: Enrollment to 12 weeks after last training session

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

    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.

    Time frame: Enrollment to 12 weeks after last training session

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

    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.

    Time frame: Enrollment to 12 weeks after last training session

07

Study locations

1 site
  • Africa Health Research Institute
    uMkhanyakude, KwaZulu-Natal, South Africa
    • Guy Harling, ScD · Principal investigator
08

References and documents

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 18445795 ↗
  • 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. PubMed 36324699 ↗

Individual participant data

Plan to share: Yes — Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.

Supporting information: Study protocol, Informed consent form, Analytic code

Time frame: 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.

Access criteria: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.

Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's planned 2 months is below that.

Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Aug 3, 2026
StartEst.
Aug 2026
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07741474
Lead sponsor
Africa Health Research Institute
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Aug 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 3, 2026

Study contacts

Guy Harling, ScD
Contact
guy.harling@ahri.org
+27352510650

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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