Clinical trial NCT04855773: Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Official title: Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: Pre-exposure Prophylaxis (PrEP)
HIV Prevention
Mobile health (mHealth)
Medication adherence
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of California, San Francisco
name: University of Miami
name: Whitman-Walker Health
name: San Francisco AIDS Foundation
name: WelTel
name: San Francisco Department of Public Health
First posted: 2021-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
timeFrame: DBS measured through 12 months
measure: Satisfaction with medical care
timeFrame: Satisfaction measured through 12 months
measure: Patient engagement
timeFrame: Patient engagement measured through 12 months
Secondary outcomes:
measure: PrEP continuation based on medication refills
timeFrame: PrEP continuation measured through 12 months
measure: Sexual satisfaction
timeFrame: Sexual satisfaction measured through 12 months
measure: Adherence self-efficacy
timeFrame: Adherence self-efficacy measured through 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
city: San Francisco
country: United States
facility: San Francisco AIDS Foundation
state: California
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References: