Adapting Effective mHealth Interventions to Improve Uptake and Adherence to HIV Pre-Exposure Prophylaxis Among Thai Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
Adapting Effective mHealth Interventions to Improve Uptake and Adherence to HIV Pre-Exposure Prophylaxis Among Thai Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
复制标题
DOI：
10.2196/46435
复制
发表时间：
2023-09-04
影响因子：
1.7
通讯作者：
中科院分区：
文献类型：
--
作者：
青年男男性行为者(YMSM)是世界上增长最快的艾滋病毒阳性人口。泰国的成人艾滋病毒血清阳性率是亚洲最高的；在曼谷，超过25%的男男性行为者艾滋病毒阳性。暴露前预防(PrEP)是推荐给所有高危个人的一种有效的艾滋病毒预防策略。PREP按规定服用是非常有效的，但PrEP利用率一直很低，而且依从性往往不足。我们建议开发和试点一种基于技术的多成分干预措施，以促进HIV阴性的泰国YMSM开始PrEP(“吸收”)的动机和持续遵守PrEP。我们将采用现有的两节课技术提供的、以激励访谈为基础的干预措施，重点关注泰国基督教青年会的PrEP使用情况。由此产生的干预被称为PrEP摄取和坚持的动机增强系统(MES-PrEP)。我们还将开发激励短信(MTM)，以发送双向激励信息，以推广PrEP的使用。拟议的研究包括三个阶段。第一阶段包括对艾滋病毒阴性的泰国基督教男同性恋者和提供者进行深入访谈，以探索启动和遵守PrEP的障碍和促进者，旨在了解干预内容。第二阶段包括利用泰国基督教青年会青年顾问委员会对MES-PrEP和MTM进行改编和测试性测试，以确定其功能和可行性。在第三阶段，我们将进行一项试点随机对照试验，以评估MES-PrEP和MTM在泰国基督教青年会中提高PrEP摄取率和依从性的可行性、可接受性和初步疗效。将60名未开始使用PrEP的HIV阴性的泰国YMSM和60名服用PrEP但未坚持PrEP的YMSM随机分为MES-PrEP和MTM(n=40)或标准PrEP咨询(n=20)。干预的可行性和可接受性将通过使用模式和系统可用性量表进行评估。将通过评估启动PrEP的比例和遵守PrEP的程度来评估初步影响。参与者将在基线以及干预后1个月、3个月和6个月完成评估。将收集遵守PrEP的生物标记物以及艾滋病毒和性传播感染的生物标记物。这项研究的招募始于2022年1月的第一阶段。2022年5月完成了对30名YMSM和5名临床提供者的定性访谈。第三阶段，即试点可行性和可接受性试验，于2023年7月开始。在项目完成后，我们将开发一种高度创新的移动健康干预措施，以支持使用PrEP的YMSM，并将准备在更大的疗效试验中进行测试。这项研究解决了泰国YMSM的一个关键问题(即高HIV发病率和低PrEP使用率)。我们正在开发两种潜在的协同作用、基于技术的、理论驱动的干预措施，旨在最大限度地利用PrEP。拟议的项目有可能对推进艾滋病毒预防研究和实施科学作出重大贡献。ClinicalTrials.gov NCT05243030；https://clinicaltrials.gov/ct2/show/NCT05243030 dr1-10.2196/46435
Young men who have sex with men (YMSM) are the fastest-growing HIV-positive population worldwide. Thailand has the highest adult HIV seroprevalence in Asia; over 25% of men having sex with men in Bangkok are HIV positive. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for all at-risk individuals. PrEP is highly effective when taken as prescribed, but PrEP utilization rate has been low, and adherence is often inadequate. We propose to develop and pilot a multicomponent, technology-based intervention to promote motivation to begin PrEP (“uptake”) and sustained adherence to PrEP among HIV-negative Thai YMSM. We will adapt an existing 2-session technology-delivered, motivational interviewing–based intervention to focus on PrEP use in YMSM in Thailand. The resulting intervention is called the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also develop motivational text messaging (MTM) to send two-way motivational messages to promote PrEP use. The proposed study includes 3 phases. Phase 1 includes in-depth interviews with HIV-negative Thai YMSM and providers to explore barriers and facilitators of PrEP initiation and adherence, aiming to inform intervention content. Phase 2 consists of adapting and beta-testing MES-PrEP and MTM for functionality and feasibility using a youth advisory board of Thai YMSM. In Phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. A total of 60 HIV-negative Thai YMSM who have not started PrEP and 60 YMSM who are on PrEP but not adherent to it will be randomized 2:1 to receive MES-PrEP and MTM (n=40) or standard PrEP counseling (n=20). The feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. The preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. Participants will complete the assessments at baseline and at 1-, 3-, and 6-month postintervention. Biomarkers of adherence to PrEP and biomarkers of HIV and sexually transmitted infections will be collected. Recruitment for this study began in January 2022 for phase 1. Qualitative interviews were completed with 30 YMSM and 5 clinical providers in May 2022. Phase 3, the pilot feasibility and acceptability trial, began in July 2023. Upon project completion, we shall have developed a highly innovative mobile health intervention to support YMSM using PrEP, which will be ready for testing in a larger efficacy trial. This study addresses a critical problem (ie, high HIV incidence and low PrEP use) among Thai YMSM. We are developing 2 potentially synergistic technology-based, theory-driven interventions aimed at maximizing PrEP use. The proposed project has the potential to make significant contributions to advancing HIV prevention research and implementation science. ClinicalTrials.gov NCT05243030; https://clinicaltrials.gov/ct2/show/NCT05243030 DERR1-10.2196/46435
影响因子：
1.7
作者：
Furberg RD;Uhrig JD;Bann CM;Lewis MA;Harris JL;Williams P;Coomes C;Martin N;Kuhns L
通讯作者：
Kuhns L