Expanding PrEP in Community of Color (EPICC+) seeks to adapt existing evidence-based provider and patient education and support tools and materials (EBT) for use in young men who have sex with men (YMSM) and to train providers in the use of the EBT to facilitate PrEP shared decision making.
Sponsored by: The Centers for Disease Control and Prevention (CDC)
Principal Investigator: Lisa Hightow-Weidman, MD, MPH | Florida State University
Florida State University
Henna Budhwani, PhD, MPH
Sylvie Naar, PhD
Kate Muessig, PhD
Allysha Maragh-Bass, PhD
Andrés Martinez, PhD
Elizabeth Tolley, PhD
University of North Carolina at Chapel Hill
MacKenzie Cottrell, PharmD, MS
Audrey Pettifor, PhD
Lina Rosengren-Hovee, MD, MPH, MS
Young men who have sex with men (YMSM) bear a heavy burden of HIV in the United States (US), particularly YMSM of color. The use of PrEP for HIV prevention holds enormous promise given its >90% efficacy at preventing HIV acquisition. Unfortunately, PrEP uptake has remained exceedingly low among YMSM, despite high levels of awareness.1-5 Complex reasons for lower uptake of PrEP among young black men who have sex with men include intersectional stigma as well as structural barriers occurring at individual, interpersonal, and societal levels. Even when there is uptake of PrEP among YMSM, long-term adherence to a daily PrEP regimen is low. In order to make progress towards the goal of no new HIV infections, YMSM need access to highly effective prevention interventions that are safe, highly acceptable and easy to use.6 Two additional PrEP options that can be leveraged include “On-demand” or “2-1-1” dosing, for oral PrEP, where a user takes 2 pills 2-24 hours before sex and 2 single doses 24 and 48 hours after sex and the newly released injectable PrEP. Both options have shown to be highly effective and acceptable for users.7-10
Evidence-based provider and patient education and support tools (EBT) are available, however, they are not being routinely used in clinical settings to increase PrEP screening, counseling, initiation, adherence, and persistence by YMSM.11, 12 Further, while EBT and educational materials for both providers and YMSM are available, these resources are not maximizing opportunities to engage in a shared decision-making (SDM) process.13, 14 Expanding PrEP in Communities of Color (EPICC+) proposes to adapt and implement existing EBT to facilitate PrEP SDM, train providers on the use of the EBT and evaluate the impact within a longitudinal cohort of racially and geographically diverse YMSM.
This project seeks to adapt and implement existing evidence-based provider and patient education and support tools (EBT) and materials for use among young men who have sex with men (YMSM) and to train providers in the use of the EBT to facilitate HIV pre-exposure prophylaxis (PrEP) shared decision making.
This study involves two distinct aims:
Aim 1 involves training providers on the use of newly developed EBT and updated PrEP clinical guidance via online modules and virtual training workshops.
Aim 2a is a hybrid effectiveness – implementation pragmatic clinical trial with a cohort of 400 YMSM ages 18-39 followed by Aim 2b, post-trial virtual focus groups with PrEP providers and clinical staff (n=36-48) to gather feedback on overall perceptions of barriers and facilitators to EBT implementation at the clinical sites.
App screenshots coming soon!
- Health Tracker – Medication and sexual activity tracking allows users to visualize patterns in their adherence, self monitor and receive feedback for improvement. Reminders help folx never miss a dose!
- Avatar Customization – Supports ongoing engagement by unlocking new accessories the more users engage with the app.
- Forum – Users can participate in forum discussions and polls to foster community support and peer-to-peer sharing within the app.
- Resources & Activities – Provides educational content across a range of health topics, as well as supports app engagement and behavior change through information and skill-building.
- Ask the Expert – Health care providers answer anonymous user questions and connect users to resources
- Tango e-gift card integration for Incentives – Allows users to redeem their choice of e-gift card as an incentive for completing study milestones like follow up surveys
- Test Kits – Users can complete in-home DBS test kits to gauge PrEP adherence and levels of protection
- Multi-language – access the app in English or Spanish
- Test the effectiveness of a provider training to increase provider knowledge of and comfort with PrEP modalities in clinical practice.
- Test the effectiveness of the EPICC+ intervention package* in increasing PrEP adherence among YMSM.
- Test the effectiveness of the EPICC+ intervention package in increasing PrEP persistence among YMSM.
- Test the effectiveness of the EPICC+ mobile app at increasing PrEP adherence and persistence among YMSM.
*EPICC+ intervention package is defined as the combination of provider training, EBT for providers, and the EPICC+ mobile app.
- Describe real-world PrEP use including factors influencing selection and change of PrEP regimens.
- Understand and describe barriers and facilitators impacting the implementation of new PrEP modalities in clinical practice.
- Evaluate the feasibility and acceptability of the EPICC+ mobile app among YMSM on PrEP.
- Evaluate the feasibility and acceptability of implementing a provider training.
- Hosek S, Rudy B, Landovitz R, et al. An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM ages 18-22 in the United States (ATN 110). International AIDS Society. Melbourne, Australia 2015.
- Anderson PL, Glidden DV, Liu A, et al. Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Science Translational Medicine 2012;4.
- Pulsipher CA, Montoya JA, Plant A, Curtis P, Holloway IW, Leibowitz AA. Addressing PrEP disparities among young gay and bisexual men in California. Los Angeles, CA: UCLA HIV/AIDS Policy Research Center at UCLA/APLA Health; 2016.
- Bauermeister JA, Meanley S, Pingel E, Soler JH, Harper GW. PrEP awareness and perceived barriers among single young men who have sex with men. Current HIV Research 2013;11:520-7.
- Strauss BB, Greene GJ, Phillips G, et al. Exploring patterns of awareness and use of HIV pre-exposure prophylaxis among young men who have sex with men. AIDS and behavior 2017;21:1288-98.
- Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV Epidemic: A Plan for the United States. JAMA 2019;321:844-5.
- Molina JM, Charreau I, Chidiac C, et al. On Demand Post Exposure Prophylaxis with Doxycycline for MSM Enrolled in a PrEP Trial. Conference on Retroviruses and Opportunistic Infections (CROI). Boston, MA2016.
- Antoni G, Tremblay C, Delaugerre C, et al. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV 2019.
- Hoornenborg E, Achterbergh RC, van der Loeff MFS, et al. Men who have sex with men more often chose daily than event-driven use of pre-exposure prophylaxis: baseline analysis of a demonstration study in Amsterdam. J Int AIDS Soc 2018;21:e25105.
- Tolley EE, Zangeneh SZ, Chau G, et al. Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077. AIDS Behav 2020;24:2520-31.
- US Public Health Service. “Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update. Clinical Providers’ Supplement”. Available at: https://www.cdc.gov/hiv/pdf/risk/prep/cdchiv-prep-provider-supplement-2017.pdf. Last accessed: December 15, 2020.
- US Public Health Service. “Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update. A Clinical Practice Guideline”. Available at: https://www.cdc.gov/hiv/pdf/risk/prep/cdchiv-prep-guidelines-2017.pdf Last accessed: December 15, 2020.
- Elopre L, McDavid C, Brown A, Shurbaji S, Mugavero MJ, Turan JM. Perceptions of HIV Pre-Exposure Prophylaxis Among Young, Black Men Who Have Sex with Men. AIDS Patient Care STDS 2018;32:511-8.
- Elwyn G, Frosch D, Rollnick S. Dual equipoise shared decision making: definitions for decision and behaviour support interventions. Implement Sci 2009;4:75.