PrEP iT!: A Pilot Test of a Mobile Peer Support Intervention to Optimize PrEP Adherence and Retention in PrEP Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels
研究概览
简要总结
The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored to young MSM, called PrEP iT! Primary aims include:
Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and refine iterations through input from a community advisory board (CAB).
Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary impact of the PrEP iT! intervention for young MSM.
详细描述
Study Design:
We propose to evaluate the feasibility, acceptability and preliminary impact of PrEP iT! in a pilot RCT (n=80). Young men who have sex with men (YMSM) recently (re)initiating PrEP will be randomized to receive either PrEP iT! plus usual care or usual care alone, and followed for 6 months with assessments at baseline, and 3- and 6-months.
PrEP iT! will use open source software that conforms to current programming standards, and can be used across all devices (desktop, laptop, smartphone, and tablet) to ensure sustainability. PrEP iT! will be developed from feedback from PrEP-using YMSM through focus groups and a community advisory board (CAB). PrEP iT! is grounded in the Information, Motivation, and Behavioral Skills model, and also draws from a model of technology adoption.
PrEP iT! intervention components are:
- PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
- Tailored feedback on PrEP adherence/non-adherence
- PrEP and sexual health information tailored for YMSM
- Text message reminders for PrEP adherence and healthcare appointments
- An "ask the expert" feature
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
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •for the pilot RCT are:
- •Prescribed PrEP by a healthcare provider;
- •Self-reported 18-29 years of age;
- •Assigned male at birth;
- •Current male gender identification;
- •Gay, bisexual or other non-heterosexual identity or has had sex with a man in the past year;
- •Confirmed HIV-negative status (before starting PrEP);
- •Started PrEP in the past 6 months (either taking PrEP for the first time or restarting PrEP after prior use) and has a current PrEP prescription;
- •English-speaking (as the intervention will be built in English);
- •Able to meet with project staff at baseline and follow-up visits;
- •Regular access to SMS or the internet, either through a mobile device, tablet computer, and/or desktop or laptop computer
排除标准
- 未提供
研究组 & 干预措施
PrEP iT! (plus usual PrEP care)
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.
干预措施: PrEP iT! (plus usual PrEP care) (Behavioral)
Usual PrEP care only
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
干预措施: Usual PrEP care (Behavioral)
结局指标
主要结局
High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels
时间窗: 6-month follow up assessment
Adherence thresholds estimated through analysis of tenofovir diphosphate (TVF-DP) levels from dried blood spot (DBS) specimens were used to categorize each participant as having a high protective level (i.e., a high likelihood of protection from HIV) of PrEP (800 or greater of emtricitabine-tenofovir disoproxil fumarate \[FTC-TDF\] and 950 or greater of FTC-tenofovir alafenamide \[FTC-TAF\]) or not. Results reported here are for high protective levels of PrEP.
Proportion of Participants With High Self-reported PrEP Adherence in the Past 7 Days
时间窗: 6-month follow up assessment
Participants were asked at the month 6 survey to respond to the following item: "In the past 7 days, how many days did you take PrEP?" Response options ranging from 0 days to 7 days, with 1 day increments. Responses of 4, 5, 6, or 7 days were categorized as having a high protective level of PrEP (i.e., a high likelihood of protection from HIV). Results reported here are for high protective levels of PrEP.
次要结局
未报告次要终点
研究者
Keith Horvath
Associate Professor
San Diego State University