Community Popular Opinion Leader Intervention for HIV Prevention Uptake in Rural South Africa (Izinkanyezi)
2026년 7월 30일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Guy Harling, ScD
- 전화번호: +27352510650
- 이메일: guy.harling@ahri.org
연구 장소
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KwaZulu-Natal
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uMkhanyakude, KwaZulu-Natal, 남아프리카
- Africa Health Research Institute
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수석 연구원:
- Guy Harling, ScD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Resident in Sixhumene study area household
Exclusion Criteria:
- Unable to provide informed consent
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of HIV self-tests distributed
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of peer conversations held
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2026년 10월 1일
연구 완료 (추정된)
2026년 10월 1일
연구 등록 날짜
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
2026년 7월 30일
처음 게시됨 (실제)
2026년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 30일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- A0006-7968/2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.
IPD 공유 기간
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.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .