Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

NCT04633200 | Completed Results

• 1 other identifier: R44MH112221-02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PrEP Medication Adherence Self Efficacy Scale

  90 days

• Intention to Follow PrEP Treatment Guidelines

  90 days

• PrEP Medication Knowledge Measure

  90 days

• Perceived Stress Scale

  90 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: DOT mobile app

Control

NO INTERVENTION

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

Interventions

DOT mobile app OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Environment and Health Group, Inc.: lead

Study Sites (1)

Environment and Health Group

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Patricia Flynn Weitzman
• Organization: Environment and Health Group

pat.weitzman@gmail.com

617-455-5976

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: February 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 28, 2023
• Results First Posted: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)