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

Official title

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

Overview

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).

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Number of HIV self-tests distributed [Time frame: From enrollment to 4 weeks after last training session]

Secondary outcome measures (6)

• Number of peer conversations held [Time frame: Enrollemnt to 4 weeks after last training session]
• Trainee HIV ART knowledge improvement [Time frame: Enrollment to end of last session (4 week period)]
• Trainee HIV PrEP knowledge improvement [Time frame: Enrollment to end of last session (4 week period)]
• Trainee generalized self-efficacy improvement [Time frame: Enrollment to end of last session (4 week period)]
• Trainee ART/PrEP self-efficacy improvement [Time frame: Enrollment to end of last session (4 week period)]
• Trainee ART/PrEP stigma reduction [Time frame: Enrollment to end of last session (4 week period)]

Eligibility criteria

Inclusion criteria

• Resident in Sixhumene study area household

Exclusion criteria

• Unable to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

South Africa · 1 center

• Africa Health Research Institute — uMkhanyakude

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. PMID 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. PMID 36324699

Identifiers

NCT: NCT07741474 · A0006-7968/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗