Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое PrEPmate
  PrEPmate is a multi-component mHealth intervention grounded in the information, motivation, behavioral skills (IMB) theory of behavior change and developed through user-centered design. PrEPmate promotes personalized communication between patients and providers through interactive weekly "check-in" messages asking participants how PrEP is going, allowing navigators to identify patients needing more help in taking PrEP, and customized daily pill-taking reminder messages. Trained PrEP navigators r
• Устройство Dot Diary
  Dot Diary is a mobile phone app that integrates an electronic pill-taking and sex diary and delivers real-time feedback on PrEP protection. Using the self-management model to increase self-efficacy and patient empowerment, participants log daily PrEP pill-taking and sexual behaviors in the app, which then provides real-time feedback on the level of protection achieved from PrEP (high, medium, low), and customized instructions on doses of PrEP needed to achieve or maintain high protection. Partic

Первичные конечные точки

• PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots [Срок оценки: DBS measured through 12 months]
• Satisfaction with medical care [Срок оценки: Satisfaction measured through 12 months]
• Patient engagement [Срок оценки: Patient engagement measured through 12 months]

Вторичные конечные точки (3)

• PrEP continuation based on medication refills [Срок оценки: PrEP continuation measured through 12 months]
• Sexual satisfaction [Срок оценки: Sexual satisfaction measured through 12 months]
• Adherence self-efficacy [Срок оценки: Adherence self-efficacy measured through 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 4 центра

• Bridge HIV, San Francisco Department of Public Health — San Francisco
• San Francisco AIDS Foundation — San Francisco
• Whitman-Walker Health — Washington D.C.
• University of Miami — Miami

Идентификаторы

NCT: NCT04855773 · 20-32976

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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