Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

Environment and Health Group

Status: Completed

Conditions: Hiv

Treatments: Other: DOT mobile app

Study type: Interventional

Funder types: Industry

Identifiers

NCT04633200

R44MH112221-02

Details and patient eligibility

About

This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men. The intervention will include: a) personalized PrEP pill reminders b) culturally- and developmentally-sensitive text messages targeting patient education, motivation, and stress c) a gamification avatar and d) a linked online community of peers. Effectively promoting PrEP adherence would reduce new HIV infections in this at-risk population, which is subject to health disparities

Full description

The project is to develop and test the effectiveness of an individually-tailored, developmentally- and culturally-sensitive, mobile health (mhealth) PrEP adherence intervention called DOT. The intervention will target culturally-diverse, young adult men, ages 18-35, who have sex with men (YMSM). The recent rise in HIV infection among young people, particularly minority YMSM, points to the value of PrEP uptake and adherence support for YMSM. In PrEP efficacy trials, younger age was the most consistent correlate with low PrEP adherence. Our DOT mhealth intervention reflects a developmental understanding of young adult decision-making, and is uniquely combined with principles from social cognitive theory, positive psychology and behavioral economics. The proposed project is based on Dr. Weitzman's successful Phase 1 trial of DOT, which led to significant improvements in PrEP adherence, PrEP treatment self-efficacy, and intention to follow PrEP treatment guidelines among the YMSM that used DOT for six weeks. Our proposed Phase 2 DOT mhealth intervention is directly responsive to Phase 1 findings by adding: 1) texts targeting motivation, patient education, and stress burden 2) online community for social support 3) linkage to the federal crisis text line 4) virtual avatar 5) cloud-based platform to view user engagement 7) calendar for clinic appointments and pharmacy refills 8) enhanced personalization of pill reminders and 9) enhanced adherence graphing. In Phase 2, we will test the effectiveness of DOT at improving PrEP adherence in a randomized controlled trial.

Enrollment: 108 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: (self report) Individuals who self-identify as a male, age 18-35, who has sex with men or who self-identify as a bisexual male or a gay male; currently taking PrEP; own a smartphone and desirous of adherence support.

Exclusion Criteria: (self report) Males who do not meet the above criteria and/or currently use I.V. drugs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence.

Treatment:

Other: DOT mobile app

Control

No Intervention group

Description:

Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.