Optimizing an mHealth Intervention to Improve Uptake and Adherence to HIV Pre-exposure Prophylaxis in Young Transgender Women: Protocol for a Multi-Phase Trial.
Optimizing an mHealth Intervention to Improve Uptake and Adherence to HIV Pre-exposure Prophylaxis in Young Transgender Women: Protocol for a Multi-Phase Trial.
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DOI：
10.2196/37659
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发表时间：
2022-05-19
影响因子：
1.7
通讯作者：
Naar, Sylvie
中科院分区：
文献类型：
--
作者：
MacDonell, Karen Kolmodin;Wang, Bo;Phanuphak, Nittaya;Janamnuaysook, Rena;Srimanus, Peevara;Rongkavilit, Chokechai;Naar, Sylvie
易受感染的青少年和新成年人（18-29岁），特别是年轻的变性妇女，是全世界艾滋病毒阳性人群中增长最快的群体。泰国是亚洲成人艾滋病毒血清阳性率最高的国家，这一人群的感染率为18%。广泛的技术为创新的移动的保健干预提供了机会。暴露前预防（PrEP）是一种有效的艾滋病毒预防策略，推荐给高危人群。当按规定服用时，PrEP非常有效，但摄取率和依从性很低，年轻人的停药率很高。我们建议开发和试点一个多组件，基于技术的干预措施，以促进PrEP的使用。我们将调整现有的2节，技术交付，动机访谈为基础的干预措施，重点放在泰国变性妇女的PrEP使用。我们称之为PrEP摄取和坚持的动机增强系统（MES-PrEP）。我们还将完善和增强YaCool，这是一款由我们的泰国团队开发并在临床上使用的集成文本消息的移动的应用程序。该应用程序的新版本被称为增强型YaCool，它可以实现性别和性健康（包括PrEP）的自我管理。我们的主要目标是开发和评估这种mHealth干预措施的初步疗效。我们将利用多阶段优化策略（MOST）来确定最有效的干预成分或成分组合，以改善泰国变性妇女的PrEP使用。该研究包括两个阶段：第一阶段（R21）包括与主要利益相关者的定性访谈，通过专题分析探索PrEP使用的障碍和促进因素，为干预措施适应提供信息。在此之后，我们将使用艾滋病毒阴性的泰国变性妇女社区咨询委员会来调整和测试MES-PrEP和增强型YaCool的功能和可行性。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Enhanced YaCool的可行性、可接受性和初步疗效。80名目前正在服用PrEP的HIV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条件下：（1）标准PrEP咨询（对照条件）;（2）MES-PrEP和标准PrEP咨询;（3）增强型YaCool和标准PrEP咨询;以及（4）MES-PrEP，增强型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的可行性和可接受性。将通过评估启动PrEP的参与者比例及其对PrEP的依从性水平来评估初步影响。评估将在基线和干预后1、3、6、9和12个月进行。将收集遵守PrEP、HIV和其他性传播感染的生物标志物。项目完成后，我们将有一个优化的mHealth干预措施，以支持跨性别妇女使用PrEP，这些妇女将准备在更大的疗效试验中进行测试。尽管泰国的变性妇女面临越来越多的艾滋病毒风险，但很少有针对她们的干预措施。需要采取有效的针对发展和文化的干预措施，以防止艾滋病毒在这一高危人群中传播。ClinicalTrials.gov NCT 05262426; https://clinicaltrials.gov/ct2/show/NCT05262426 PRR1-10.2196/37659
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 PRR1-10.2196/37659
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影响因子：
5.6
作者：
Blumenthal, Jill;Pasipanodya, Elizabeth C.;Moore, David J.
通讯作者：
Moore, David J.
影响因子：
5.5
作者：
Collins, Linda M.;Dziak, John J.;Kugler, Kari C.;Trail, Jessica B.
通讯作者：
Trail, Jessica B.
DOI：
10.1016/s2352-3018(15)00206-4
发表时间：
2015-12
期刊：
The lancet. HIV
影响因子：
--
作者：
Deutsch MB;Glidden DV;Sevelius J;Keatley J;McMahan V;Guanira J;Kallas EG;Chariyalertsak S;Grant RM;iPrEx investigators
通讯作者：
iPrEx investigators
影响因子：
168.9
作者：
Des Jarlais, DC;Paone, D;Friedman, SR
通讯作者：
Friedman, SR
影响因子：
4.4
作者：
Dubov, Alex;Altice, Frederick L.;Fraenkel, Liana
通讯作者：
Fraenkel, Liana