一款基于理论的移动应用程序，用于提高男男性行为者的暴露前预防措施使用率：一项随机对照试验的方案
A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
作者信息
Jones Jeb, Dominguez Karen, Stephenson Rob, Stekler Joanne D, Castel Amanda D, Mena Leandro A, Jenness Samuel M, Siegler Aaron J, Sullivan Patrick S
机构信息
Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.
Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.
出版信息
JMIR Res Protoc. 2020 Feb 21;9(2):e16231. doi: 10.2196/16231.
BACKGROUND
HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low.
OBJECTIVE
The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States.
METHODS
In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription.
RESULTS
Participant recruitment began in January 2020.
CONCLUSIONS
This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16231.
背景
HealthMindr是一款针对男男性行为者（MSM）的预防艾滋病毒的手机应用程序。在之前的一项试点研究中，发现HealthMindr在用户中是可接受的，并显示出在增加男男性行为者中暴露前预防（PrEP）使用率方面的初步效果。PrEP是一种高效的艾滋病毒预防干预措施；然而，其使用率仍然很低。
目的
本研究的目的是评估一款手机应用程序在美国南部增加男男性行为者中PrEP使用率的疗效。
方法
在这项随机对照试验中，我们将评估HealthMindr在以下三个美国南部城市增加男男性行为者中PrEP使用率的疗效：佐治亚州亚特兰大市；密西西比州杰克逊市；以及华盛顿特区。总共将招募657名男性，并以2:1的比例随机分配到干预组和对照组。干预组的参与者将可以使用完整的HealthMindr应用程序，其中包含有关PrEP的信息和资源（例如常见问题、风险评估工具和PrEP提供者定位器）、其他艾滋病毒预防信息、订购免费艾滋病毒/性传播感染检测试剂盒的能力，以及与药物使用和心理健康相关的其他资源。对照组的参与者将使用HealthMindr应用程序，但只能访问研究时间表和一个消息中心以与研究人员沟通。参与者将完成季度调查，以评估在12个月随访期间自我报告的PrEP使用率。自我报告的PrEP使用率将通过干血斑检测和/或上传PrEP处方照片进行核实。
结果
参与者招募于2020年1月开始。
结论
这项试验将确定HealthMindr应用程序是否可以增加美国南部男男性行为者中PrEP的使用率。
试验注册
ClinicalTrials.gov NCT03763942；https://clinicaltrials.gov/ct2/show/NCT03763942。
国际注册报告识别码（IRRID）：PRR1-10.2196/16231。
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