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

NCT04855773 | Recruiting

• 1 other identifier: 20-32976
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections; Sexually Transmitted Diseases

Keywords

Pre-exposure Prophylaxis (PrEP); HIV Prevention; Mobile health (mHealth); Medication adherence

Outcome Measures

Primary Outcomes (3)

• PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots

  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.

  DBS measured through 12 months

• Satisfaction with medical care

  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

  Satisfaction measured through 12 months

• Patient engagement

  Patient engagement will be measured by the short-version Patient Activation Measure (PAM).

  Patient engagement measured through 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

PrEPmate

EXPERIMENTAL

Participants randomized to this study arm will receive the PrEPmate mHealth intervention (bi-directional text messaging with PrEP navigators/clinic staff) to support PrEP adherence and continuation.

Other: PrEPmate

Dot Diary mobile application

EXPERIMENTAL

Participants randomized to this study arm will download and use the Dot Diary mobile application on a personal device, to support PrEP adherence and continuation.

Device: Dot Diary

Interventions

PrEPmate OTHER

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 reach out to participants who indicate they need assistance via text or phone call and provide tailored support. Additionally, the platform supports 2-way communication between patients and PrEP navigators, including reminders for upcoming clinic visits. Participants are provided links to key information about PrEP (PrEP Basics), and video testimonials of peers taking PrEP. Messages are available in English and Spanish. PrEPmate is aimed at both patients and PrEP navigators.

PrEPmate

Dot Diary DEVICE

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. Participants can also view a weekly and monthly calendar, including visualizations of the proportion of sex acts covered by PrEP. Finally, the Dot Diary app incorporates gamification components, including an ability to earn sex-positive badges, to increase engagement. Dot Diary is aimed only at patients.

Dot Diary mobile application

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: cisgender man, transgender man (assigned female sex at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of California, San Francisco: collaborator
• University of Miami: collaborator
• Whitman-Walker Health: collaborator
• San Francisco AIDS Foundation: collaborator
• WelTel: collaborator
• San Francisco Department of Public Health: collaborator

Study Sites (4)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

ACTIVE NOT RECRUITING

San Francisco AIDS Foundation

San Francisco, California, 94114, United States

RECRUITING

Whitman-Walker Health

Washington D.C., District of Columbia, 20009, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 22, 2021
• Study Start: July 21, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)