Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM

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

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Other: DOT mobile app

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02141
      • Environment and Health Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wilson Self-reported Medication Adherence Scale	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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Medication Adherence Self Efficacy Scale	This scale was adapted by Kogelman and Weitzman from the Johnson HIV Adherence Self-Efficacy Scale. The PrEP medication adherence self efficacy scale was developed to assess one's confidence in one's ability to adhere to their PrEP medication treatment plan. The minimum score = 0, maximum score =80. Higher score indicates greater PrEP medication adherence self efficacy.	90 days
Intention to Follow PrEP Treatment Guidelines	This measure was developed by Kogelman and Weitzman to assess an individual's intention to engage in key behaviors that are recommended while on PrEP treatment, e.g. concomitant use of condoms and testing for HIV every 3 months. The minimum score=0, the maximum score=16. Higher score means greater intention to follow PrEP treatment guidelines.	90 days
PrEP Medication Knowledge Measure	This measure was developed by Kogelman and Weitzman to assess an individual's knowledge of PrEP medication through questions about medication purpose, side effects, etc. Minimum score =0, maximum score = 8. Higher score means greater knowledge about PrEP medication.	90 days
Perceived Stress Scale	The Perceived Stress Scale, developed by Cohen et al. (1983), is designed to measure the degree to which one perceives situations in one's life as stressful. The minimum score=0, maximum score=40. Higher score indicates higher perceived stress.	90 days

Collaborators and Investigators

• Sponsor: Environment and Health Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R44MH112221-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No