CRF_RAND_PA in ATN 140 - A Novel Mobile App to Support Linkage to HIV/STI Testing and PrEP for Young Men who have Sex with Men

Randomization CRF dataset
Study Description
The LYNX protocol involved qualitative formative work (aim 1), an open technical pilot (aim 2) to refine the LYNX app, and a pilot randomized controlled trial (RCT) to evaluate acceptability, feasibility, and preliminary efficacy (aim 3) of the LYNX app to increase HIV/STI testing and PrEP uptake among HIV-uninfected young sexual minority men (SMM) aged 15-24. Participants were enrolled at two sites in Chicago, IL and Tampa, FL. Aim 1 was conducted over a 6-month period and included 40 participants; data included focus groups and in-depth interviews. Aim 2 was conducted over a 4 month period and included 15 participants; data included an online exit interview, a computer-assisted self-interview (CASI), and app analytics. Aim 3 was conducted over a 9--month period, and included 60 participants randomized 2:1 to either receive LYNX or standard of care; data included CASI, app analytics, case-report form (CRF) data on study implementation, and in-depth interviews in the LYNX arm. In early testing, participants found most parts of the LYNX app easy to use. Participants found the app most useful in helping them track their sexual partners and motivating them to get tested for HIV and STIs. In the larger pilot study, the app was highly acceptable, with almost all participants using the app at least once -- on average, participants used the app 15 times during the 6 month period. Rates of HIV testing were higher in the group receiving the LYNX app compared with a group receiving usual care. Rates of linkage to PrEP services were similar between the groups. HIV-uninfected young men who have sex with men (YMSM) ages 15-24 years, assigned male sex at birth, and male-identified, were enrolled at two study sites in Chicago, IL and Tampa, FL

随机化病例报告表（CRF）数据集
研究概况
LYNX方案涵盖三项研究内容：目标1为形成性定性研究，目标2为开放性技术试点研究，用于优化LYNX应用程序；目标3为试点随机对照试验（RCT），旨在评估LYNX应用程序在提升15至24岁未感染人类免疫缺陷病毒（HIV）的年轻性少数男性（SMM）的HIV/性传播感染（STI）检测率与暴露前预防（PrEP）药物使用率方面的可接受性、可行性与初步疗效。研究对象在美国伊利诺伊州芝加哥市与佛罗里达州坦帕市的两个研究中心入组。
目标1研究为期6个月，共纳入40名研究对象，采集数据包括焦点小组访谈资料与深度访谈资料。
目标2研究为期4个月，纳入15名研究对象，采集数据包括线上退出访谈、计算机辅助自我访谈（CASI）以及应用程序分析数据。
目标3研究为期9个月，纳入60名研究对象，按照2:1的比例随机分为LYNX干预组与常规护理组；采集数据包括计算机辅助自我访谈（CASI）数据、应用程序分析数据、研究实施相关的病例报告表（CRF）数据，以及LYNX干预组的深度访谈资料。
前期测试结果显示，绝大多数研究对象认为LYNX应用的各项功能易于操作。研究对象反馈，该应用在帮助其追踪性伴侣、督促其进行HIV与STI检测方面实用性最强。
在本次大规模试点研究中，该应用的接受度极高，几乎所有研究对象均至少使用过一次该应用，研究对象平均在6个月内使用该应用15次。LYNX应用组的HIV检测率显著高于常规护理组，而两组间的PrEP服务衔接率无显著差异。
本研究的入组对象为15至24岁、出生时被指派为男性且自我性别认同为男性的未感染HIV的男男性行为青年（YMSM），入组地点为美国伊利诺伊州芝加哥市与佛罗里达州坦帕市的两个研究中心。