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Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

Sponsor
Environment and Health Group, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04633200
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
16.9
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: DOT mobile app
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Other: DOT mobile app
DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. PrEP adherence [90 days]

    Wilson 3-item PrEP adherence self-report

Secondary Outcome Measures

  1. PrEP adherence self efficacy [90 days]

    Johnson 12-item Adherence Self-Efficacy Scale (ASES)

  2. Intention to follow PrEP treatment guidelines [90 days]

    5 item Intention to follow PrEP treatment guidelines developed by Weitzman & Kogelman

  3. PrEP knowledge [90 day]

    6-item PrEP knowledge Tool, developed by Weitzman and Kogelman, to assess participants' knowledge of PrEP through questions about medication purpose, side effects, concomitant condom use, HIV testing

  4. Stress Burden [90 days]

    10-item Perceived Stress Scale (Cohen et al., 1983)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Environment and Health Group Cambridge Massachusetts United States 02141

Sponsors and Collaborators

  • Environment and Health Group, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patricia Weitzman, Senior Scientist, Environment and Health Group, Inc.
ClinicalTrials.gov Identifier:
NCT04633200
Other Study ID Numbers:
  • R44MH112221-02
First Posted:
Nov 18, 2020
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 22, 2022