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一项针对南非性少数男性的基于技能的HIV血清学状态披露干预措施:干预适应方案及一项试点随机对照试验。

A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial.

作者信息

Daniels Joseph, Peters Remco P H, Medina-Marino Andrew, Bongo Cikizwa, Stephenson Rob

机构信息

Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.

Foundation for Professional Development, East London, South Africa.

出版信息

JMIR Res Protoc. 2022 May 16;11(5):e36845. doi: 10.2196/36845.

DOI:10.2196/36845
PMID:35576574
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9152729/
Abstract

BACKGROUND

Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context.

OBJECTIVE

We aim to adapt HR into a new culturally grounded intervention entitled Speaking Out & Allying Relationships for GBMSM and then assess its feasibility in Eastern Cape, South Africa.

METHODS

The study will have 2 aims. For aim 1-adaptation-we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention's design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner.

RESULTS

Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively.

CONCLUSIONS

GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36845.

摘要

背景

在南非,感染艾滋病毒的男同性恋者、双性恋者及其他与男性发生性关系的男性(GBMSM)对抗逆转录病毒治疗的依从性较低,原因是他们在与性伴侣和恋爱伴侣进行信息披露及预防行为管理方面的技能有限。因此,在艾滋病毒不一致的伴侣关系中,艾滋病毒传播风险很高,但如果能有效调整,现有的干预措施可能会改善这些结果。健康关系(HR)是一种行为干预措施,最初以小组形式面对面开展,共进行5次,旨在培养应对与艾滋病毒相关压力及性风险情况的技能,提高向伴侣披露艾滋病毒信息的决策能力,并与伴侣建立和维持更安全的性行为。HR有效地改善了预防行为,但尚未针对美国以外的地区进行调整。

目的

我们旨在将HR调整为一种新的、基于文化背景的干预措施,名为“GBMSM发声与结盟关系”,然后在南非东开普省评估其可行性。

方法

该研究有两个目标。对于目标1(调整),我们将采用以人为本的设计方法。最初的干预调整将包括整合“检测不到=不传播”及暴露前预防教育,开发视频会议形式的干预内容,并根据初步数据设计用于技能培养的角色扮演和影片。之后,将对GBMSM进行访谈和调查,以评估他们对干预措施的偏好,并与医疗保健提供者和信息技术专家进行焦点小组讨论,以评估干预措施的设计。最后,将进行可用性测试,以确定其功能和内容理解情况。参与者将包括处于恋爱关系中的感染艾滋病毒的GBMSM(n = 15)以及从事该人群艾滋病毒护理和规划工作的医疗保健提供者和信息技术(n = 7)专家。对于目标2,我们将通过试点随机对照设计来检验调整后的干预措施的可行性。每组将有60人。将对干预组进行可行性调查和访谈,并收集两组关于关系和治疗依从性结果的行为及生物医学评估数据。所有参与者均为感染艾滋病毒且与艾滋病毒阴性或状况不明的伴侣处于恋爱关系中的GBMSM。

结果

干预措施的调整于2021年8月开始。GBMSM干预偏好的初步调整和完善于2021年12月完成。可用性和可行性评估预计分别于2022年3月和2024年2月完成。

结论

在南非,GBMSM需要有效的干预措施来解决伴侣关系动态、艾滋病毒预防以及抗逆转录病毒治疗依从性和病毒抑制的治疗结果等问题。利用日常社交网络技术的使用(如视频会议)、“检测不到=不传播”教育以及暴露前预防来更新针对南非GBMSM的现有干预措施,有可能加强关于艾滋病毒治疗和预防的关系沟通,进而改善结果。

国际注册报告识别码(IRRID):DERR1-10.2196/36845。

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