Mobile-Based Application "MyChoices" to Increase Uptake of HIV Testing, Detection of New HIV Infections, and Linkage to Care and Prevention Services by Young Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Acceptability: System Usability Scale
研究概览
简要总结
This study is testing the acceptability and feasibility of MyChoices, a mobile application (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who have sex with men (YMSM).
详细描述
"MyChoices", an app adapted from HealthMindr and developed using iterative feedback from youth, is being refined to to maximize acceptability among YMSM. "MyChoices" was guided by the Social Cognitive Theory (SCT) model and includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences in order to impact behavior change. (1) Tracking and Self-Monitoring HIV Risk: In order to target self-regulation, brief surveys within the app are used to assess behavioral patterns of YMSM, particularly around sexual relationships, which are then used to help customize the app for each user. (2) HIV and sexually transmitted infection (STI) Prevention Information: In order to improve self-efficacy for HIV testing and HIV prevention overall, quizzes and infographics that appeal to YMSM have been incorporated into the app, focusing on promotion of HIV prevention and regular HIV testing. The app also allows users to order OraQuick HIV home testing kits and STI home collection kits (for rectal and urethral gonorrhea and Chlamydia and syphilis). Additionally, the app includes information on testing sites and local PrEP clinics (e.g., telephone, address, hours of testing, etc), and external links to specific site webpages that are near the user (determined using GPS technology). (3) HIV Testing Plan: Acknowledging the central role of goal setting and environmental influences on health behavior, the app allows users to create a HIV testing plan by allowing them to compare and choose different screening options (e.g., home self-testing, antigen, rapid). Questions about HIV transmission behaviors and testing history are then asked to create a tailored testing plan. After a HIV testing plan is developed, users have the option to customize reminders for the timeframe selected (e.g., user is pinged every 3 months as a reminder to get tested). Users are able to select from a list of phrases or create their own to ensure privacy. Moreover, geofencing technology allows users to be notified when in the vicinity of testing locations, based on the Geo Positioning System (GPS) location, during the testing timeframe.
This study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No HIV test in the past 3 months (self-reported).
- •Not known to be HIV-infected (self-reported).
- •Not currently taking PrEP (self-report).
- •Owns or leases a phone with Android platform (for Aims 2 and 3) or iOS platform (Aim 3 only), has an active data plan, and willing to download the MyChoices application.
- •Willing to attend an in-person baseline study visit in Boston or the Bronx and complete online follow-up visits.
- •Able to understand, read, and speak English.
- •Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months.
- •Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:
- •at least one episode of condomless anal intercourse with an HIV-infected or unknown HIV status male or transfemale partner during the last 6 months; or
- •anal intercourse with 2 or more male or transfemale sex partners during the last 6 months; or
- •exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or
- •sex with a male or transfemale partner and has had an STI during the last 6 months.
排除标准
- •Any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
- •Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product and evidence of vaccine-induced seropositivity.
- •Known to be HIV-infected.
- •Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
结局指标
主要结局
Acceptability: System Usability Scale
时间窗: 3 months
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
Feasibility: Frequency of Logins
时间窗: 3 months
Number of individuals who logged into app at least one time after set up
次要结局
- Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP(6 months)
- Number of Times Participants Used Distinct App Components(3 months)
- Number of HIV Home Testing Kits Ordered(6 months)
- Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV(6 months)
- App Content and Functionality Most Utilized(3 months)
研究者
Kenneth H. Mayer, MD
Principal Investigator
Fenway Community Health