Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

Hiv Clinical Trial

Official title:

Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633200
• Other study ID #: R44MH112221-02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2023
• Source: Environment and Health Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
United States	Environment and Health Group	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Environment and Health Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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