Clinical trial NCT04633200: Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
Official title: Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Lead sponsor: Environment and Health Group, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility 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.

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

Primary outcomes:
measure: Wilson Self-reported Medication Adherence Scale
timeFrame: 90 days
Secondary outcomes:
measure: PrEP Medication Adherence Self Efficacy Scale
timeFrame: 90 days
measure: Intention to Follow PrEP Treatment Guidelines
timeFrame: 90 days
measure: PrEP Medication Knowledge Measure
timeFrame: 90 days
measure: Perceived Stress Scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Environment and Health Group
state: Massachusetts
Study officials:
References: