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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
108
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.
Environment and Health Group
Cambridge, Massachusetts, United States
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.
Time frame: 90 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 90 days