eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Protective Levels of PrEP
研究概览
简要总结
The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for men who have sex with men (MSM) and transgender women (TW).
To reach this goal, the investigators will compare study outcomes among persons randomized to receive a mobile app (eSTEP) intervention tailored to the needs of MSM and TW plus usual PrEP care to a group of persons who only receive usual PrEP care.
详细描述
Study Design:
The investigators propose to evaluate the feasibility, acceptability, and preliminary impact of eSTEP in a pilot RCT with MSM and TW who are either PrEP naïve or have not been taking PrEP for at least 3 months, randomized (2:1) to receive either the eSTEP intervention or usual PrEP prevention services, and followed for 6 months with assessments at baseline, 12- and 24-weeks. eSTEP is a mobile application (i.e., app) with interactive PrEP components to increase PrEP uptake, and components to optimize PrEP retention and adherence.
eSTEP is grounded in the Information, Motivation, Behavioral Skills model [IMB] and includes the following components:
- PrEP information
- Identifying and addressing barriers to starting PrEP
- Information about stigma and managing stigma
- Matching the best PrEP option to one's personal life circumstances
- Appointment Scheduling
- PrEP Adherence Reminders & Self-monitoring for those who start PrEP
- PrEP Appointment Reminders
- A Frequently Asked Question (FAQ) Control arm participants will not be offered the eSTEP mobile app, but both the eSTEP arm and control arm will be asked to attend a brief telephone visit with a PrEP navigator, which is usual care for the clinic.
Study Sample:
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Assigned male sex at birth
- •Current male & MSM identity OR transfeminine (woman, transgender woman, or non-binary) identification
- •Self-reported HIV-negative status
- •English-speaking (since the pilot intervention will be developed in English)
- •Owner of an Android or iPhone mobile device and access to this phone during the 6-month study.
- •Willingness and ability to attend HIV prevention visits at the HIV treatment and prevention clinic.
- •Consent to allow study team access to study-relevant PHI
- •Eligible for PrEP following CDC guidelines (in the past 6 months had a sexual partner with HIV with unknown or detectable viral load, inconsistently used condoms, and/or was diagnosed with a sexually transmitted infection)
- •Has never used PrEP or has not used PrEP in the past 3 months
排除标准
- •Was a Community Advisory Board Member or participant in the eSTEP focus groups
- •Assigned female or intersex at birth
- •Living with HIV
- •Already taking PrEP
- •Under 18 years old
- •Does not own a mobile phone
- •Does not speak or read English (since the pilot intervention will be developed in English)
研究组 & 干预措施
Control Arm
Usual PrEP clinical care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Protective Levels of PrEP
时间窗: Throughout the 24 weeks of study participation, starting after PrEP initiation
Percentage of participants who achieve protective levels of PrEP depending on the type of PrEP participants are taking: 1) if taking daily oral or 2-1-1 PrEP, protective level of PrEP is defined by drug level thresholds in the blood; 2) if taking injectable PrEP, protective level of PrEP is defined by timely (+/- 1 week for the second injection; +/- 2 weeks for any subsequent injection) administration.
PrEP Initiation
时间窗: Within 24 weeks of enrollment
Percentage of study participants who initiate PrEP
次要结局
- PrEP Persistence(Throughout the 24 weeks of study participation, starting after PrEP initiation)
研究者
Keith Horvath
Professor
San Diego State University