SBIR-STTR Award

Environment and Health Group, Tufts HIV/AIDS Clinic, and the Boston-area PrEP Community of Practice will collaborate under the leadership of Patricia Weitzman, PhD, to develop and test the feasibility and short-term effectiveness of the first-ever individually-tailored, developmentally- and culturally-sensitive, mobile (mhealth) PrEP adherence tool. It will target culturally-diverse, young adult men ages 20-29 who have sex with men (YMSM). When PrEP is taken daily, it can reduce HIV risk by up to 92%. The CDC estimates PrEP is appropriate for 500,000 MSM in the U.S. Impact models show even modest PrEP adherence could reduce new HIV infections among MSM by 29% over 20 years. The recent rise in HIV infection among young adults age 20-29, particularly minority YMSM, points to the value of PrEP uptake and adherence support for culturally-diverse YMSM. In PrEP trials, younger age was the most consistent correlate with low PrEP adherence. Extensive mobile phone penetration among young adults makes mhealth an ideal, low-cost method for providing PrEP adherence support to YMSM. We bring together a developmental understanding of young adult decision making with principles from social learning theory and positive psychology for supporting PrEP adherence. The proposed project is based on Dr. Weitzman's successful Phase 1 (and current Phase 2) anti-retroviral therapy (ART) mhealth adherence intervention for HIV+ African Americans, which combined tailored pill reminders with age- and culturally-sensitive motivational and educational texts. Experts suggest building PrEP adherence interventions on proven ART adherence interventions as many PrEP adherence facilitators are the same as ART. Moreover, the growing literature on mhealth shows it is a powerful approach to supporting adherence across conditions. In addition to building on our prior ART mhealth tool, we address facilitators/barriers identified in PrEP RCT follow up studies, and CDC PrEP adherence recommendations. Moreover, formative focus groups with diverse YMSM will allow us to identify and target unique adherence barriers and facilitators in this group. The intervention will provide tailored pill reminders with PrEP education texts, as well as developmentally-sensitive motivational texts. We will include sleep hygiene and alcohol use messages, which have direct relevance to young adults. By using a low-cost, accessible mobile phone tool, the intervention eliminates several access barriers to support, which can be a particular problem for low income and minority patients. Our overarching goal is to help stop the rise in HIV among YMSM.

Public Health Relevance Statement:
Project Narrative The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages. The intervention targets culturally-diverse young adult men who have sex with men (YMSM), who are at high risk for both HIV and non-adherence to PrEP medication. Supporting PrEP adherence would help reduce new HIV infections in this group. 1

Project Terms:
Acquired Immunodeficiency Syndrome; Address; Adherence; Affect; African American; Age; AIDS/HIV problem; Alcohol consumption; Anal Sex; Anti-Retroviral Agents; Area; base; black men who have sex with men; Boston; Brain; Car Phone; Centers for Disease Control and Prevention (U.S.); Chronic; Clinic; Community of Practice; Community Practice; comparative efficacy; condoms; cost; Coupled; Decision Making; design; Development; Developmental Process; Diagnosis; Disclosure; Doctor of Philosophy; Dose; Education; Effectiveness; efficacy trial; Ensure; Environment; Esthesia; evidence base; experience; Female; Focus Groups; Follow-Up Studies; Foundations; Funding; Goals; Gold; Grant; Guidelines; Health; Health education; high risk; HIV; HIV Infections; HIV risk; Hygiene; improved; Incidence; Individual; Informal Social Control; Intervention; intervention program; Knowledge; Latino; Leadership; Literature; Low income; male; medication compliance; member; men; men who have sex with men; Meta-Analysis; Methods; mHealth; Minority; Modeling; Motivation; Participant; Patient Education; Patients; Penetration; personalized approach; Pharmaceutical Preparations; Phase; pill; pre-exposure prophylaxis; Prevention; programs; Psychology; Randomized; Randomized Controlled Trials; Recommendation; Research; Research Support; Rest; Risk; Self Efficacy; sex; Sleep; Small Business Innovation Research Grant; social; social cognitive theory; Social Network; Stress; System; Teenagers; Testing; Text; therapy adherence; Time; tool; truvada; United States National Institutes of Health; uptake; Victimization; Wood material; young adult

Environment and Health Group, Tufts Infectious Disease Clinic, and Palmetto AIDS Life Support Services, will collaborate under the leadership of Patricia Weitzman, PhD, to develop and test the effectiveness of the first-ever 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). When the PrEP pill is taken daily, it can reduce HIV risk by 92-99%. The CDC estimates the daily PrEP pill is appropriate for 500,000 MSM in the U.S. Impact models show even modest increases in PrEP adherence could reduce new HIV infections among MSM by 29% over 20 years. 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. Extensive mobile phone penetration among young adults makes mhealth an ideal, low-cost method for providing PrEP adherence support to culturally-diverse YMSM. 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, all toward the goal of supporting PrEP adherence. 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 recommended new features and enhancements, including: 1) new texts targeting stress burden 2) new online community for social support 3) new linkage to the federal crisis text line 4) new gamification via a virtual avatar 5) new automatic time-zone adjustments 6) new cloud-based platform to view user engagement 7) new calendar for clinic appointments and pharmacy refills 8) enhanced personalization of pill reminders and 9) enhanced adherence graphing designed for sharing with healthcare providers. In Phase 2, we will test the effectiveness of DOT at improving PrEP adherence in a randomized controlled trial. Our goal is to help stop the rise in HIV among YMSM. Another potential benefit of DOT is advancement of the evidence base on how mhealth might address patient support issues in HIV prevention and other healthcare concerns toward the larger goal of reducing health disparities.

Public Health Relevance Statement:
Narrative The proposed 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.

Project Terms:
Accounting; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; African American; Age; aged; AIDS prevention; Appointment; base; behavioral economics; Calendar; Car Phone; Centers for Disease Control and Prevention (U.S.); Clinic; cloud based; Cognitive; commercialization; Communicable Diseases; condoms; Control Groups; cost; Decision Making; design; Development; Doctor of Philosophy; Effectiveness; effectiveness evaluation; effectiveness testing; efficacy trial; Ensure; Environment; evidence base; Exposure to; Feedback; Fibrinogen; Follow-Up Studies; Goals; Graph; Guidelines; Health; health disparity; health equity; Health Personnel; Healthcare; high risk; high risk men; HIV; HIV diagnosis; HIV Infections; HIV risk; Human immunodeficiency virus test; improved; Individual; Intake; Intention; Intervention; Knowledge; Latino; Leadership; Life; Link; Marketing; Mediating; medication compliance; men; men who have sex with men; Methods; mHealth; Minority; Modeling; Motivation; online community; Participant; Patient Education; Patient Self-Report; Patients; peer; Penetration; Pharmaceutical Preparations; Pharmacy facility; Phase; phase I trial; pill; Population; Populations at Risk; pre-exposure prophylaxis; prevent; Prevention; primary outcome; Privacy; Psychology; Public Health; Randomized Controlled Trials; Recommendation; Reporting; Research; Resources; Risk; Self Efficacy; Services; sex; social cognitive theory; Social support; Stress; success; Suggestion; Testing; Text; Text Messaging; therapy design; Time; tool; treatment guidelines; truvada; uptake; virtual; young adult