MacDonell Karen Kolmodin, Wang Bo, Phanuphak Nittaya, Janamnuaysook Rena, Srimanus Peevara, Rongkavilit Chokechai, Naar Sylvie
Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, Detroit, MI, United States.
Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, United States.
JMIR Res Protoc. 2022 May 19;11(5):e37659. doi: 10.2196/37659.
Vulnerable adolescents and emerging adults (aged 18-29 years), particularly young transgender women, are among the fastest-growing HIV positive populations worldwide. Thailand has the highest adult HIV seroprevalence in Asia, with a rate of infection among this population of 18%. Widespread technology offers opportunities for innovative mobile health (mHealth) interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for at-risk individuals. PrEP is highly effective when taken as prescribed, but uptake and adherence have been low, with high discontinuation rates among youth.
We propose to develop and pilot a multi-component, technology-based intervention to promote PrEP usage. We will adapt an existing 2-session, technology-delivered, motivational interviewing-based intervention to focus on PrEP use in transgender women in Thailand. We call this the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also refine and enhance YaCool, a mobile app with integrated text messaging developed and used clinically by our Thai team. The new version of the app is called Enhanced YaCool, and it enables self-management of gender and sexual health (including PrEP). Our primary aim is to develop and assess the preliminary efficacy of this mHealth intervention.
We will utilize a multiphase optimization strategy (MOST) to identify the most effective intervention component or combination of components to improve PrEP usage in Thai transgender women. The study includes two phases: phase I (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Following this, we will adapt and beta-test MES-PrEP and Enhanced YaCool for functionality and feasibility using a community advisory board of HIV-negative Thai transgender women. In phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool. Eighty HIV-negative participants who are currently taking PrEP and 80 participants who are not will be randomized to four conditions: (1) standard PrEP counseling (the control condition); (2) MES-PrEP and standard PrEP counseling; (3) Enhanced YaCool and standard PrEP counseling; and (4) MES-PrEP, Enhanced YaCool, and standard PrEP counseling. Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of participants who initiate PrEP and their level of adherence to PrEP. Assessments will be at baseline and 1, 3, 6, 9, and 12 months postintervention. Biomarkers of adherence to PrEP, HIV, and other sexually transmitted infections will be collected.
Upon project completion, we will have an optimized mHealth intervention to support the use of PrEP by transgender women that will be ready for testing in a larger efficacy trial.
Even though transgender women in Thailand face increasing risks of HIV, few interventions have targeted them. Effective developmentally and culturally tailored interventions are needed to prevent HIV transmission in this high-risk population.
ClinicalTrials.gov NCT05262426; https://clinicaltrials.gov/ct2/show/NCT05262426.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37659.
脆弱青少年和新兴成年人（18 - 29岁），尤其是年轻的跨性别女性，是全球范围内感染艾滋病毒人数增长最快的群体之一。泰国是亚洲成年人艾滋病毒血清阳性率最高的国家，该人群的感染率为18%。广泛应用的技术为创新型移动健康（mHealth）干预措施提供了机会。暴露前预防（PrEP）是一项针对高危个体推荐的有效艾滋病毒预防策略。按规定服用时，PrEP非常有效，但使用率和依从性一直较低，青少年中的停药率很高。
我们提议开发并试点一种基于技术的多成分干预措施，以促进PrEP的使用。我们将调整现有的两阶段、基于技术交付、以动机性访谈为基础的干预措施，使其聚焦于泰国跨性别女性对PrEP的使用。我们将其称为PrEP使用与依从性动机增强系统（MES-PrEP）。我们还将完善和增强YaCool，这是一款由我们泰国团队开发并在临床中使用的集成短信功能的移动应用程序。该应用程序的新版本称为增强版YaCool，它能够实现性别和性健康（包括PrEP）的自我管理。我们的主要目标是开发并评估这种mHealth干预措施的初步疗效。
我们将采用多阶段优化策略（MOST）来确定最有效的干预成分或成分组合，以提高泰国跨性别女性对PrEP的使用。该研究包括两个阶段：第一阶段（R21）包括对关键利益相关者进行定性访谈，通过主题分析探索PrEP使用的障碍和促进因素，为干预措施的调整提供信息。在此之后，我们将利用艾滋病毒阴性的泰国跨性别女性社区咨询委员会，对MES-PrEP和增强版YaCool进行功能和可行性方面的调整及测试。在第二阶段（R33），我们将进行一项基于MOST设计的试验，以评估MES-PrEP和增强版YaCool的可行性、可接受性和初步疗效。80名目前正在服用PrEP的艾滋病毒阴性参与者和80名未服用PrEP的参与者将被随机分配到四种情况：（1）标准PrEP咨询（对照情况）；（2）MES-PrEP和标准PrEP咨询；（3）增强版YaCool和标准PrEP咨询；（4）MES-PrEP、增强版YaCool和标准PrEP咨询。将通过使用模式和系统可用性量表评估干预措施的可行性和可接受性。通过评估开始服用PrEP的参与者比例及其对PrEP的依从水平来评估初步影响。评估将在基线以及干预后1、3、6、9和12个月进行。将收集PrEP、艾滋病毒和其他性传播感染的依从性生物标志物。
项目完成后，我们将拥有一种优化的mHealth干预措施，以支持跨性别女性使用PrEP，该措施可准备好在更大规模的疗效试验中进行测试。
尽管泰国的跨性别女性面临着越来越高的艾滋病毒感染风险，但针对她们的干预措施却很少。需要制定有效且符合其发展阶段和文化背景的干预措施，以防止这一高危人群中的艾滋病毒传播。
ClinicalTrials.gov NCT05262426；https://clinicaltrials.gov/ct2/show/NCT05262426。
国际注册报告识别码（IRRID）：PRR1-10.2196/37659。
