Liu Albert, Coleman Kenneth, Bojan Kelly, Serrano Pedro Alonso, Oyedele Temitope, Garcia Amayvis, Enriquez-Bruce Elizabeth, Emmanuel Patricia, Jones Jeb, Sullivan Patrick, Hightow-Weidman Lisa, Buchbinder Susan, Scott Hyman
Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States.
Department of Medicine, University of California, San Francisco, San Francisco, CA, United States.
JMIR Res Protoc. 2019 Jan 25;8(1):e10659. doi: 10.2196/10659.
Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM.
The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT).
This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups.
Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019.
The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population.
ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10659.
美国男男性行为者（YMSM）的艾滋病毒和性传播感染（STI）发病率最高，而艾滋病毒和性传播感染检测以及暴露前预防（PrEP）的接受率最低。年轻人中几乎普遍拥有手机，这为利用移动健康应用程序来提高YMSM的艾滋病毒/性传播感染检测率和PrEP接受率提供了契机。
本项目的目标是开发并完善LYNX，这是一款新型移动应用程序，用于支持美国YMSM与艾滋病毒/性传播感染检测及PrEP服务的衔接，并在一项试点随机对照试验（RCT）中评估LYNX的可接受性和可行性。
本研究方案将分三个阶段进行：一个迭代开发阶段，针对20名YMSM开展一系列3个焦点小组讨论以完善LYNX应用程序；在15名YMSM中进行开放技术试点以优化应用程序的可用性；然后在60名有感染艾滋病毒风险的未感染艾滋病毒的YMSM中进行为期6个月的试点RCT。LYNX应用程序采用信息、动机和行为技能理论模型开发，包括一个用于跟踪性行为的电子日记（信息）、一个用于促进准确风险认知的个性化风险评分（信息/动机）、检测提醒（动机/行为技能），以及获得家庭艾滋病毒/性传播感染检测选项和基于地理空间的艾滋病毒/性传播感染检测护理地点的途径（行为技能）。将通过对使用模式的应用程序分析以及在3个月和6个月时通过计算机辅助自我访谈进行的可接受性量表评估可行性和可接受性。我们还将通过比较干预组和对照组中在6个月试点期间至少检测一次的YMSM比例以及成功与PrEP提供者衔接的比例来评估初步疗效。
形成性工作目前正在进行中。LYNX试点RCT将于2018年10月开始招募，研究结果将于2019年公布。
LYNX应用程序是首批旨在提高YMSM的艾滋病毒/性传播感染检测率和PrEP接受率的移动应用程序之一。由于低风险认知是年轻人进行艾滋病毒/性传播感染检测和使用PrEP的障碍，LYNX中的个性化风险评估和交互式性日记可以帮助YMSM更好地了解他们的艾滋病毒风险，并为检测艾滋病毒/性传播感染和开始使用PrEP提供动力。再加上基于社区的招募，这款新型移动应用程序有很大潜力覆盖并吸引目前未接受护理的YMSM，并提高这一弱势群体的艾滋病毒/性传播感染检测率和PrEP接受率。
ClinicalTrials.gov NCT03177512；https://clinicaltrials.gov/ct2/show/NCT03177512（由WebCite存档于http://www.webcitation.org/73c917wAw）。
国际注册报告识别码（IRRID）：PRR1-10.2196/10659。
