A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial

Katie B Biello, Elliot Marrow, Matthew J Mimiaga, Patrick Sullivan, Lisa Hightow-Weidman, Kenneth H Mayer, Katie B Biello, Elliot Marrow, Matthew J Mimiaga, Patrick Sullivan, Lisa Hightow-Weidman, Kenneth H Mayer

Abstract

Background: HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM.

Objective: The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app.

Methods: This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY.

Results: App refinement is underway. Enrollment for the pilot RCT began in October 2018.

Conclusions: MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.

International registered report identifier (irrid): PRR1-10.2196/10694.

Keywords: HIV; adolescents; mHealth; men who have sex with men; mobile phone; pre-exposure prophylaxis.

Conflict of interest statement

Conflicts of Interest: None declared.

©Katie B Biello, Elliot Marrow, Matthew J Mimiaga, Patrick Sullivan, Lisa Hightow-Weidman, Kenneth H Mayer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.01.2019.

Figures

Figure 1
Figure 1
Theoretical model for the MyChoices app development. PrEP: pre-exposure prophylaxis.
Figure 2
Figure 2
The MyChoices pilot randomized controlled trial schema.
Figure 3
Figure 3
The MyChoices home screen.
Figure 4
Figure 4
The MyChoices test plan.

References

    1. Centers for Disease Control and Prevention. 2016. Nov, [2018-11-04]. HIV Surveillance Report: Diagnoses of HIV Infection in the United States and Dependent Areas, 2015 .
    1. Centers for Disease Control and Prevention. 2015. Jul, [2018-11-04]. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data – United States and 6 dependent areas? 2013 .
    1. Wejnert C, Hess KL, Rose CE, Balaji A, Smith JC, Paz-Bailey G, NHBS Study Group Age-Specific Race and Ethnicity Disparities in HIV Infection and Awareness Among Men Who Have Sex With Men--20 US Cities, 2008-2014. J Infect Dis. 2016 Mar 01;213(5):776–83. doi: 10.1093/infdis/jiv500.jiv500
    1. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JHS, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR, HPTN 052 Study Team Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493–505. doi: 10.1056/NEJMoa1105243.
    1. Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-Analysis of High-Risk Sexual Behavior in Persons Aware and Unaware They are Infected With HIV in the United States. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2005;39(4):446–453. doi: 10.1097/01.qai.0000151079.33935.79.
    1. Severe P, Jean Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, Edwards A, Bang H, Nicotera J, Godfrey C, Gulick RM, Johnson WD, Pape JW, Fitzgerald DW. Early versus Standard Antiretroviral Therapy for HIV-Infected Adults in Haiti. N Engl J Med. 2010 Jul 15;363(3):257–265. doi: 10.1056/nejmoa0910370.
    1. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapía M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernández T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker L, Mayer KH, Kallás EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng J, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV, iPrEx Study Team Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587–99. doi: 10.1056/NEJMoa1011205.
    1. McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016 Jan 02;387(10013):53–60. doi: 10.1016/S0140-6736(15)00056-2. S0140-6736(15)00056-2
    1. Sanchez TH, Sineath RC, Kahle EM, Tregear SJ, Sullivan PS. The Annual American Men's Internet Survey of Behaviors of Men Who Have Sex With Men in the United States: Protocol and Key Indicators Report 2013. JMIR Public Health Surveill. 2015;1(1):e3. doi: 10.2196/publichealth.4314. v1i1e3
    1. Krakower DS, Mimiaga MJ, Rosenberger JG, Novak DS, Mitty JA, White JM, Mayer KH. Limited Awareness and Low Immediate Uptake of Pre-Exposure Prophylaxis among Men Who Have Sex with Men Using an Internet Social Networking Site. PLoS One. 2012;7(3):e33119. doi: 10.1371/journal.pone.0033119. PONE-D-11-19249
    1. Mayer K, Biello K, Novak D, Krakower D, Mimiaga M. PrEP uptake disparities in a diverse on-line sample of US men who have sex with men. Conference on Retroviruses and Opportunistic Infections; February 13-16, 2017; Seattle, Washington. 2017. Feb,
    1. Arnett J. Emerging Adulthood: The Winding Road from the Late Teens Through the Twenties. New York, NY: Oxford University Press; 2014.
    1. Gruber HE, Voneche JJ, editors. The essential Piaget. London: Routledge & Kegan Paul PLC; 1977.
    1. Anderson AM, Higgins MK, Ownby RL, Waldrop-Valverde D. Changes in neurocognition and adherence over six months in HIV-infected individuals with cocaine or heroin dependence. AIDS Care. 2015;27(3):333–7. doi: 10.1080/09540121.2014.985183.
    1. Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165–73. doi: 10.1016/j.amepre.2008.09.040.S0749-3797(08)00892-1
    1. Blas MM, Alva IE, Carcamo CP, Cabello R, Goodreau SM, Kimball AM, Kurth AE. Effect of an online video-based intervention to increase HIV testing in men who have sex with men in Peru. PLoS One. 2010 May 03;5(5):e10448. doi: 10.1371/journal.pone.0010448.
    1. Blas MM, Menacho LA, Alva IE, Cabello R, Orellana ER. Motivating men who have sex with men to get tested for HIV through the internet and mobile phones: a qualitative study. PLoS One. 2013;8(1):e54012. doi: 10.1371/journal.pone.0054012. PONE-D-12-27239
    1. Hirshfield S, Chiasson MA, Joseph H, Scheinmann R, Johnson WD, Remien RH, Shaw FS, Emmons R, Yu G, Margolis AD. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. PLoS One. 2012;7(10):e46252. doi: 10.1371/journal.pone.0046252. PONE-D-11-25517
    1. Ko N, Hsieh C, Wang M, Lee C, Chen C, Chung A, Hsu S. Effects of Internet popular opinion leaders (iPOL) among Internet-using men who have sex with men. J Med Internet Res. 2013 Feb 25;15(2):e40. doi: 10.2196/jmir.2264. v15i2e40
    1. Muessig KE, Pike EC, Legrand S, Hightow-Weidman LB. Mobile phone applications for the care and prevention of HIV and other sexually transmitted diseases: a review. J Med Internet Res. 2013 Jan 04;15(1):e1. doi: 10.2196/jmir.2301. v15i1e1
    1. Sullivan PS, Driggers R, Stekler JD, Siegler A, Goldenberg T, McDougal SJ, Caucutt J, Jones J, Stephenson R. Usability and Acceptability of a Mobile Comprehensive HIV Prevention App for Men Who Have Sex With Men: A Pilot Study. JMIR Mhealth Uhealth. 2017 Mar 09;5(3):e26. doi: 10.2196/mhealth.7199. v5i3e26
    1. Biello K, Coffey-Esquivel J, Hosek S, Belzer M, Sullivan P, Oleson S. Development of a mobile-based application to increase uptake of HIV testing among young US men who have sex with men. 2016 International AIDS Conference; July 18-22, 2016; Durban, South Africa. 2016. Jul,
    1. Bandura A. The anatomy of stages of change. Am J Health Promot. 1997;12(1):8–10. doi: 10.4278/0890-1171-12.1.8.
    1. Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143–64. doi: 10.1177/1090198104263660.
    1. Milena ZD, Dainora G, Alin S. Qualitative Research Methods: A comparison between focus-group and in-depth interview. Annals of the University of Ordea, Economic Science Series. 2008;17(4):1279–1283.
    1. Kruger RA, Casey MA. Focus Groups: A Practical Guide For Applied Research. Thousand Oaks, CA: Sage Publications; 2015.
    1. Carlsen B, Glenton C. What about N? A methodological study of sample-size reporting in focus group studies. BMC Med Res Methodol. 2011 Mar 11;11:26. doi: 10.1186/1471-2288-11-26. 1471-2288-11-26
    1. Brooke J. SUS – A quick and dirty usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland IL, editors. Usability evaluation in industry. London, GB: Taylor & Francis; 1996. pp. 189–194.
    1. Beebe J. Rapid Assessment Process. In: Kempf-Leonard K, editor. Encyclopedia of social measurement. Atlanta, GA: Elsevier; 2005. pp. 285–291.
    1. Creswell J. Qualitative Inquiry and Research Design: Choosing among Five Approaches. Los Angeles, CA: Sage Publications; 2012.
    1. Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19–26.S0895435698001383
    1. Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: Adding an adjective rating scale. Journal of Usability Studies. 2009;4(3):114–123.
    1. Napper LE, Fisher DG, Reynolds GL. Development of the perceived risk of HIV scale. AIDS Behav. 2012 May;16(4):1075–83. doi: 10.1007/s10461-011-0003-2.
    1. Jamil M, Guy RJ, Bavinton BR, Fairley C, Grulich A, Holt M, Smith K, Chen M, McNulty A, Conway D, Keen P, Bradley J, Russell D, Kaldor J, Prestage G, FORTH Investigator Group HIV testing self-efficacy is associated with higher HIV testing frequency and perceived likelihood to self-test among gay and bisexual men. Sex Health. 2017 Apr;14(2):170–178. doi: 10.1071/SH16100.SH16100
    1. Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES) J Behav Med. 2007 Oct;30(5):359–70. doi: 10.1007/s10865-007-9118-3.
    1. Brafford LJ, Beck KH. Development and validation of a condom self-efficacy scale for college students. J Am Coll Health. 1991 Mar;39(5):219–25. doi: 10.1080/07448481.1991.9936238.
    1. Krieger N. Epidemiology and the web of causation: has anyone seen the spider? Soc Sci Med. 1994 Oct;39(7):887–903.
    1. Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001 Jun;40(6):642–53. doi: 10.1097/00004583-200106000-00008. S0890-8567(09)60467-6
    1. WHO ASSIST Working Group The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183–94.
    1. Kroenke K, Strine TW, Spitzer RL, Williams JBW, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163–73. doi: 10.1016/j.jad.2008.06.026.S0165-0327(08)00282-6
    1. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7. doi: 10.1001/archinte.166.10.1092.166/10/1092
    1. Hatzenbuehler ML, Nolen-Hoeksema S, Erickson SJ. Minority stress predictors of HIV risk behavior, substance use, and depressive symptoms: results from a prospective study of bereaved gay men. Health Psychol. 2008 Jul;27(4):455–62. doi: 10.1037/0278-6133.27.4.455.2008-09239-007
    1. Meltzer-Brody S, Churchill E, Davidson JR. Derivation of the SPAN, a brief diagnostic screening test for post-traumatic stress disorder. Psychiatry Research. 1999 Oct;88(1):63–70. doi: 10.1016/s0165-1781(99)00070-0.
    1. Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai J, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R, PROMIS Cooperative Group The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179–94. doi: 10.1016/j.jclinepi.2010.04.011. S0895-4356(10)00173-3
    1. Catania JA, Osmond D, Stall RD, Pollack L, Paul J P, Blower S, Binson D, Canchola JA, Mills TC, Fisher L, Choi KH, Porco T, Turner C, Blair J, Henne J, Bye LL, Coates TJ. The continuing HIV epidemic among men who have sex with men. Am J Public Health. 2001 Jun;91(6):907–14.
    1. Latkin CA, Forman V, Knowlton A, Sherman S. Norms, social networks, and HIV-related risk behaviors among urban disadvantaged drug users. Social Science & Medicine. 2003 Feb;56(3):465–476. doi: 10.1016/s0277-9536(02)00047-3.
    1. Williams DR, Yan Y, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335–51. doi: 10.1177/135910539700200305.2/3/335
    1. Zickuhr K, Smith A. Pew Research Center. 2012. Apr 13, [2018-11-04]. Digital Differences
    1. Smith A. Pew Research Center. 2015. Apr 01, [2018-11-04]. U.S. Smartphone Use in 2015
    1. Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86–94. doi: 10.1007/s10461-007-9261-4.
    1. Snead MC, O'Leary AM, Mandel MG, Kourtis AP, Wiener J, Jamieson DJ, Warner L, Malotte CK, Klausner JD, O'Donnell L, Rietmeijer CA, Margolis AD. Relationship between social cognitive theory constructs and self-reported condom use: assessment of behaviour in a subgroup of the Safe in the City trial. BMJ Open. 2014 Dec 30;4(12):e006093. doi: 10.1136/bmjopen-2014-006093. bmjopen-2014-006093
    1. Detry MA, Lewis RJ. The intention-to-treat principle: how to assess the true effect of choosing a medical treatment. JAMA. 2014 Jul 02;312(1):85–6. doi: 10.1001/jama.2014.7523.1884555

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