Community Popular Opinion Leader Intervention for HIV Prevention Uptake in Rural South Africa (Izinkanyezi)
30 июля 2026 г. обновлено: 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).
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Guy Harling, ScD
- Номер телефона: +27352510650
- Электронная почта: guy.harling@ahri.org
Места учебы
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KwaZulu-Natal
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uMkhanyakude, KwaZulu-Natal, Южная Африка
- Africa Health Research Institute
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Главный следователь:
- Guy Harling, ScD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- Resident in Sixhumene study area household
Exclusion Criteria:
- Unable to provide informed consent
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Экспериментальный: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of HIV self-tests distributed
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of peer conversations held
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Barriers and Facilitators to Participant Engagement Assessed Through Semi-Structured Interviews and Focus Group Discussions
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
1 октября 2026 г.
Завершение исследования (Оцененный)
1 октября 2026 г.
Даты регистрации исследования
Первый отправленный
21 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
30 июля 2026 г.
Первый опубликованный (Действительный)
3 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
3 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
30 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- A0006-7968/2024
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Quantitative data from the pre/post questionnaire and any qualitative data that can be meaningfully anonymized.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .