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Clinical Trials/NCT04633200
NCT04633200
Completed
Not Applicable

Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM

Environment and Health Group, Inc.1 site in 1 country108 target enrollmentFebruary 1, 2021
ConditionsHiv

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hiv
Sponsor
Environment and Health Group, Inc.
Enrollment
108
Locations
1
Primary Endpoint
Wilson Self-reported Medication Adherence Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
July 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patricia Weitzman

Senior Scientist

Environment and Health Group, Inc.

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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Wilson Self-reported Medication Adherence Scale

Time Frame: 90 days

The self-reported medication adherence scale, developed by Wilson et al. (2016), is designed to assess self-reported medication adherence to HIV-related and other types of medications. In this study, it was used to assess self-reported PrEP medication adherence. Minimum score=0, maximum=299.9. Higher score means better adherence.

Secondary Outcomes

  • PrEP Medication Adherence Self Efficacy Scale(90 days)
  • PrEP Medication Knowledge Measure(90 days)
  • Intention to Follow PrEP Treatment Guidelines(90 days)
  • Perceived Stress Scale(90 days)

Study Sites (1)

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