PMID- 30681964 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200930 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 8 IP - 1 DP - 2019 Jan 25 TI - Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. PG - e10659 LID - 10.2196/10659 [doi] LID - e10659 AB - BACKGROUND: Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM. OBJECTIVE: The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT). METHODS: This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups. RESULTS: Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019. CONCLUSIONS: The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10659. CI - (c)Albert Liu, Kenneth Coleman, Kelly Bojan, Pedro Alonso Serrano, Temitope Oyedele, Amayvis Garcia, Elizabeth Enriquez-Bruce, Patricia Emmanuel, Jeb Jones, Patrick Sullivan, Lisa Hightow-Weidman, Susan Buchbinder, Hyman Scott. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.01.2019. FAU - Liu, Albert AU - Liu A AUID- ORCID: 0000-0003-0320-823X AD - Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States. AD - Department of Medicine, University of California, San Francisco, San Francisco, CA, United States. FAU - Coleman, Kenneth AU - Coleman K AUID- ORCID: 0000-0003-4332-3347 AD - Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States. FAU - Bojan, Kelly AU - Bojan K AUID- ORCID: 0000-0003-2967-7632 AD - John H Stroger Jr Hospital, Chicago, IL, United States. AD - The Ruth M Rothstein CORE Center, Chicago, IL, United States. FAU - Serrano, Pedro Alonso AU - Serrano PA AUID- ORCID: 0000-0001-9504-5647 AD - John H Stroger Jr Hospital, Chicago, IL, United States. AD - The Ruth M Rothstein CORE Center, Chicago, IL, United States. FAU - Oyedele, Temitope AU - Oyedele T AUID- ORCID: 0000-0001-9783-6661 AD - John H Stroger Jr Hospital, Chicago, IL, United States. AD - The Ruth M Rothstein CORE Center, Chicago, IL, United States. FAU - Garcia, Amayvis AU - Garcia A AUID- ORCID: 0000-0002-6849-6263 AD - Department of Pediatrics, University of South Florida, Tampa, Tampa, FL, United States. FAU - Enriquez-Bruce, Elizabeth AU - Enriquez-Bruce E AUID- ORCID: 0000-0002-7821-2746 AD - Department of Pediatrics, University of South Florida, Tampa, Tampa, FL, United States. FAU - Emmanuel, Patricia AU - Emmanuel P AUID- ORCID: 0000-0003-1464-6665 AD - Department of Pediatrics, University of South Florida, Tampa, Tampa, FL, United States. FAU - Jones, Jeb AU - Jones J AUID- ORCID: 0000-0001-9165-1658 AD - Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States. FAU - Sullivan, Patrick AU - Sullivan P AUID- ORCID: 0000-0002-7728-0587 AD - Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States. FAU - Hightow-Weidman, Lisa AU - Hightow-Weidman L AUID- ORCID: 0000-0002-2421-923X AD - Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. FAU - Buchbinder, Susan AU - Buchbinder S AUID- ORCID: 0000-0003-2404-0712 AD - Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States. AD - Department of Medicine, University of California, San Francisco, San Francisco, CA, United States. FAU - Scott, Hyman AU - Scott H AUID- ORCID: 0000-0001-8775-7214 AD - Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States. AD - Department of Medicine, University of California, San Francisco, San Francisco, CA, United States. LA - eng SI - ClinicalTrials.gov/NCT03177512 GR - P30 MH062246/MH/NIMH NIH HHS/United States GR - T32 MH019105/MH/NIMH NIH HHS/United States GR - U19 HD089881/HD/NICHD NIH HHS/United States PT - Journal Article DEP - 20190125 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC6367663 OTO - NOTNLM OT - HIV testing OT - adolescent OT - men who have sex with men OT - mobile app OT - pre-exposure prophylaxis OT - sexually transmitted diseases OT - sexually transmitted infections OT - youth COIS- Conflicts of Interest: AL has led studies for which Gilead Sciences has donated the study drug. SB has been an investigator on studies for which Gilead Sciences has donated the study drug. EDAT- 2019/01/27 06:00 MHDA- 2019/01/27 06:01 PMCR- 2019/01/25 CRDT- 2019/01/26 06:00 PHST- 2018/03/31 00:00 [received] PHST- 2018/09/13 00:00 [accepted] PHST- 2018/07/08 00:00 [revised] PHST- 2019/01/26 06:00 [entrez] PHST- 2019/01/27 06:00 [pubmed] PHST- 2019/01/27 06:01 [medline] PHST- 2019/01/25 00:00 [pmc-release] AID - v8i1e10659 [pii] AID - 10.2196/10659 [doi] PST - epublish SO - JMIR Res Protoc. 2019 Jan 25;8(1):e10659. doi: 10.2196/10659.