Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic. PrEP is the use of a daily anti-HIV medications by HIV-negative people to help prevent HIV infection.
详细描述
This is a clinic-based, multi-site, randomized, two-arm study to compare the effectiveness of two mobile technologies designed to support PrEP adherence and continuation in cisgender and transgender men who have sex with men (MSM) and transgender women (TGW). All study participants will receive PrEP per standard of care at each of the study sites.
Participants randomized to PrEPmate will receive an interactive bidirectional text-messaging intervention that supports PrEP use through personalized communication between patients and providers. Key components include (1) weekly short message service (SMS) check-ins and a bidirectional SMS messaging platform; (2) customized daily SMS pill-taking reminders; (3) link to online PrEP Basics and videos and testimonials.
Participants randomized to Dot Diary will receive a mobile app that promotes self-management of PrEP use and sexual health. Key components include (1) a digital pill-taking and sexual diary, with pill-taking reminders; (2) sex-positive badges earned via app use; and (3) real-time feedback on protection levels afforded by PrEP. Each participant will be followed for approximately 12 months. Staff at the participating clinics will also participate in in-depth interviews to give feedback on implementation challenges and experiences in the clinic-setting, and experience working with patients using the mobile technologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
- •Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months
- •Age 15 years or older
- •Willing and able to provide written informed consent
- •Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages
- •Able to understand, read, and speak English or Spanish
- •Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation based on at least one of the following:
- •Initiated PrEP within the past 6 months, or
- •Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age < 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use
排除标准
- •Currently enrolled in another PrEP intervention study
- •Unable to complete 12 month study participation
- •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
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
时间窗: DBS measured through 12 months
PrEP adherence will be measured by tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS). Adequate adherence will be defined as having a TFV-DP ≥ 700 femtomoles/punch in DBS for daily PrEP users, which has been associated with high levels of protection in prior PrEP trials.
Satisfaction with medical care
时间窗: Satisfaction measured through 12 months
Satisfaction with medical care will be measured by the Consumer Assessment of Health Care Processes and Services (CAHPS), a critical tool for evaluating patient satisfaction and patient-centeredness of care
Patient engagement
时间窗: Patient engagement measured through 12 months
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).
次要结局
- PrEP continuation based on medication refills(PrEP continuation measured through 12 months)
- Sexual satisfaction(Sexual satisfaction measured through 12 months)
- Adherence self-efficacy(Adherence self-efficacy measured through 12 months)
研究者
Albert Liu
Clinical Research Director
Public Health Foundation Enterprises, Inc.