Mobile App (UPrEPU) to Monitor Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: Protocol for a User-Centered Approach to Mobile App Design and Development

Carol Strong, Huei-Jiuan Wu, Yuan-Chi Tseng, Chien-Wen Yuan, Yi-Fang Yu, Jay Chiehen Liao, Yi-Wen Chen, Yi-Chen Hung, Chia-Wen Li, Po-Hsien Huang, Nai-Ying Ko, Stephane Wen-Wei Ku, Carol Strong, Huei-Jiuan Wu, Yuan-Chi Tseng, Chien-Wen Yuan, Yi-Fang Yu, Jay Chiehen Liao, Yi-Wen Chen, Yi-Chen Hung, Chia-Wen Li, Po-Hsien Huang, Nai-Ying Ko, Stephane Wen-Wei Ku

Abstract

Background: Daily and on-demand pre-exposure prophylaxis (PrEP) has been well demonstrated to effectively prevent HIV acquisition for men who have sex with men (MSM). More than half of the MSM PrEP users in Taiwan prefer on-demand PrEP; however, on-demand PrEP involves a complicated dosing regimen because it requires precoital and postcoital dosing and sex events are hard to anticipate. Although there are a growing number of mobile apps designed to improve access to HIV prevention services and HIV medication adherence, few mobile apps focus on adherence to PrEP or are designed to accommodate a complicated, on-demand PrEP dosing schedule.

Objective: The aim of this project is to evaluate the usability of a newly developed mobile app (UPrEPU) to assist MSM PrEP users to self-monitor their adherence to either daily or on-demand PrEP using a user-centered scheme.

Methods: This research will be conducted in 2 phases: app development and usability study. In the app development phase, we will first conduct formative research with end users and stakeholders through in-depth interviews; the results will provide PrEP users' and PrEP navigators' personas as material used in the app conceptualization stage. PrEP navigators are individuals in the health care system that help HIV-negative individuals who need assistance in accessing PrEP care. A low-fidelity prototype of the app feature will be formatted by applying a participatory design approach to engage PrEP users, designers, and app developers in the design process of the app. Then, a high-fidelity prototype of the app will be developed for the usability study and refined iteratively by the multidisciplinary team and new internal testers. Internal testers include the research team consisting of experts in public health, infectious disease, and industrial design and a close network of the research team that is taking PrEP. In the usability study phase, we will enroll 70 MSM PrEP users and follow them up for 4 months. Usability, feasibility, and effectiveness of adherence monitoring will be evaluated.

Results: Refinement of the UPrEPU app is currently ongoing. The usability study commenced in May 2020.

Conclusions: The UPrEPU app is one of the first apps designed to help MSM PrEP users to self-manage their PrEP schedule better regardless of dosing modes. With a design-thinking approach and adapting to the cultural context in Taiwan's MSM population, this novel app will have substantial potential to be acceptable and feasible and contribute to the reduction of new HIV infections.

Trial registration: ClinicalTrials.gov NCT04248790; https://ichgcp.net/clinical-trials-registry/NCT04248790.

International registered report identifier (irrid): PRR1-10.2196/20360.

Keywords: event-driven; men who have sex with men; mobile apps; pre-exposure prophylaxis; sexual behavior; user-centered design approach.

Conflict of interest statement

Conflicts of Interest: None declared.

©Carol Strong, Huei-Jiuan Wu, Yuan-Chi Tseng, Chien-Wen Yuan, Yi-Fang Yu, Jay Chiehen Liao, Yi-Wen Chen, Yi-Chen Hung, Chia-Wen Li, Po-Hsien Huang, Nai-Ying Ko, Stephane Wen-Wei Ku. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.12.2020.

References

    1. Lo Y, Chuang J, Huang Y, Liu D, Chou J. GBD 2017 and HIV estimates for Taiwan. The Lancet HIV. 2020 Apr;7(4):e224. doi: 10.1016/S2352-3018(20)30040-0.
    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. The Lancet. 2016 Jan 2;387(10013):53–60. doi: 10.1016/S0140-6736(15)00056-2.
    1. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C, Partners PrEP Study Team Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 02;367(5):399–410. doi: 10.1056/NEJMoa1108524.
    1. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT, TDF2 Study Group Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 02;367(5):423–34. doi: 10.1056/NEJMoa1110711.
    1. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet. 2013 Jun 15;381(9883):2083–2090. doi: 10.1016/S0140-6736(13)61127-7.
    1. Molina J, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Préau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Doré V, Marchand L, Simon M, Etien N, Aboulker J, Meyer L, Delfraissy J, ANRS IPERGAY Study Group On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 03;373(23):2237–46. doi: 10.1056/NEJMoa1506273.
    1. Guidance on Pre-Exposure Oral Prophylaxis (PrEP) for Serodiscordant Couples, Men and Transgender Women Who Have Sex with Men at High Risk of HIV: Recommendations for Use in the Context of Demonstration Projects. World Health Organization. 2012. [2018-10-01].
    1. Policy brief: pre-exposure prophylaxis (PrEP): WHO expands recommendation on oral pre-exposure prophylaxis of HIV infection (PrEP) World Health Organization. 2015. [2020-08-03]. .
    1. Saag MS, Benson CA, Gandhi RT, Hoy JF, Landovitz RJ, Mugavero MJ, Sax PE, Smith DM, Thompson MA, Buchbinder SP, Del Rio C, Eron JJ, Fätkenheuer G, Günthard HF, Molina J, Jacobsen DM, Volberding PA. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2018 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2018 Jul 24;320(4):379–396. doi: 10.1001/jama.2018.8431.
    1. McCormack S, Fidler S, Fisher M, British HIV Association. British Association for Sexual Health and HIV The British HIV Association/British Association for Sexual Health and HIV Position Statement on pre-exposure prophylaxis in the UK. Int J STD AIDS. 2012 Jan;23(1):1–4. doi: 10.1258/ijsa.2011.051211.
    1. European Guidelines for treatment of HIV-positive adults in Europe. European AIDS Clinincal Society (EACS) 2020. [2018-10-01]. .
    1. Hoornenborg E, Achterbergh RC, van der Loeff MFS, Davidovich U, van der Helm JJ, Hogewoning A, van Duijnhoven YT, Sonder GJ, de Vries HJ, Prins M. 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 Intern AIDS Soc. 2018 Mar 30;21(3):e25105. doi: 10.1002/jia2.25105.
    1. Molina JM, Ghosn J, Béniguel L, Rojas-Castro D, Algarte-Genin M, Pialoux G, Delaugerre C, Yazdanpanah Y, Katlama C, Segouin C, Morel S, Pintado C, Loze B, Le Mestre S, Gibowski S, Dore V, Assoumou L, Spire B, Costagliola D, Prevenir ANRS study group Incidence of HIV-infection in the ANRS Prévenir study in Paris region with daily or on-demand PrEP with TDF/FTC. 22nd International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. 2018.
    1. Lee Y, Chang S, Lin K, Chang L, Liu W, Wu C, Sun H, Hung C, Chang S. Awareness and willingness towards pre-exposure prophylaxis against HIV infection among individuals seeking voluntary counselling and testing for HIV in Taiwan: a cross-sectional questionnaire survey. BMJ Open. 2017 Oct 16;7(10):e015142. doi: 10.1136/bmjopen-2016-015142.
    1. Yen-Hao Chu I, Wen-Wei Ku S, Li C, Toh HS, Yang C, Wu K, Wu H, Chen S, Kuo J, Lin H, Ko N. Taiwan guideline on oral pre-exposure prophylaxis for HIV prevention - 2018 update. J Microbiol Immunol Infect. 2020 Feb;53(1):1–10. doi: 10.1016/j.jmii.2019.09.003.
    1. Wu H, Strong C, Ku S. Syphilis acquisition and dosing schedule for pre-exposure prophylaxis (PrEP) users in Taiwan PrEP demonstration project. 22nd International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. 2018.
    1. Wu H, Ku SW, Li C, Ko N, Yu T, Chung A, Strong C. Factors Associated with Preferred Pre-Exposure Prophylaxis Dosing Regimen Among Men Who Have Sex with Men in Real-World Settings: A Mixed-Effect Model Analysis. AIDS Behav. 2020 Jul 08; doi: 10.1007/s10461-020-02964-5.
    1. Huang P, Wu H, Strong C, Jan F, Mao L, Ko N, Li C, Cheng C, Ku SW. Unspeakable PrEP: a qualitative study of sexual communication, problematic integration, and uncertainty management among men who have sex with men in Taiwan. Journal of Applied Communication Research. 2019 Nov 24;47(6):611–627. doi: 10.1080/00909882.2019.1693608.
    1. Grosskopf NA, LeVasseur MT, Glaser DB. Use of the Internet and mobile-based "apps" for sex-seeking among men who have sex with men in New York City. Am J Mens Health. 2014 Nov;8(6):510–20. doi: 10.1177/1557988314527311.
    1. Phillips G, Magnus M, Kuo I, Rawls A, Peterson J, Jia Y, Opoku J, Greenberg AE. Use of geosocial networking (GSN) mobile phone applications to find men for sex by men who have sex with men (MSM) in Washington, DC. AIDS Behav. 2014 Sep;18(9):1630–7. doi: 10.1007/s10461-014-0760-9.
    1. Goedel WC, Duncan DT. Geosocial-Networking App Usage Patterns of Gay, Bisexual, and Other Men Who Have Sex With Men: Survey Among Users of Grindr, A Mobile Dating App. JMIR Public Health Surveill. 2015;1(1):e4. doi: 10.2196/publichealth.4353.
    1. Ko N, Tseng P, Huang Y, Chen Y, Hsu S. Seeking sex partners through the internet and mobile phone applications among men who have sex with men in Taiwan. AIDS Care. 2016 Jul;28(7):927–31. doi: 10.1080/09540121.2015.1131969.
    1. Jenkins Hall W, Sun CJ, Tanner AE, Mann L, Stowers J, Rhodes SD. HIV-Prevention Opportunities With GPS-Based Social and Sexual Networking Applications for Men Who Have Sex With Men. AIDS Educ Prev. 2017 Feb;29(1):38–48. doi: 10.1521/aeap.2017.29.1.38.
    1. Muessig KE, LeGrand S, Horvath KJ, Bauermeister JA, Hightow-Weidman LB. Recent mobile health interventions to support medication adherence among HIV-positive MSM. Curr Opin HIV AIDS. 2017 Sep;12(5):432–441. doi: 10.1097/COH.0000000000000401.
    1. Dillingham R, Ingersoll K, Flickinger TE, Waldman AL, Grabowski M, Laurence C, Wispelwey E, Reynolds G, Conaway M, Cohn WF. PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. AIDS Patient Care STDS. 2018 Jun;32(6):241–250. doi: 10.1089/apc.2017.0303.
    1. Trang K, Sullivan PS, Hinton DE, Worthman CM, Le MG, Jovanovic T. Feasibility, acceptability, and design of a mobile health application for high-risk men who have sex with men in Hanoi, Vietnam. The Lancet Global Health. 2020 Apr;8:S14. doi: 10.1016/s2214-109x(20)30155-8.
    1. LeGrand S, Knudtson K, Benkeser D, Muessig K, Mcgee A, Sullivan PS, Hightow-Weidman L. Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Dec 18;7(12):e10448. doi: 10.2196/10448.
    1. Sharpe JD, Kamara MT. A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sex Health. 2018 Nov;15(6):587–594. doi: 10.1071/SH18120.
    1. Goldenberg T, McDougal SJ, Sullivan PS, Stekler JD, Stephenson R. Preferences for a Mobile HIV Prevention App for Men Who Have Sex With Men. JMIR Mhealth Uhealth. 2014 Oct 29;2(4):e47. doi: 10.2196/mhealth.3745.
    1. Aquino Jr PT, Filgueiras LVL. User modeling with personas. Latin American conference on Human-computer interaction; October 23-26, 2005; Cuernavaca, Mexico. 2005.
    1. Floyd IR, Cameron Jones M, Twidale MB. Resolving Incommensurable Debates: A Preliminary Identification of Persona Kinds, Attributes, and Characteristics. Artifact. 2008 Apr;2(1):12–26. doi: 10.1080/17493460802276836.
    1. Matthews T, Judge T, Whittaker S. How do designers and user experience professionals actually perceive and use personas?. SIGCHI conference on human factors in computing systems; May 2012; Austin Texas. 2012.
    1. Carroll JM. Encountering Others: Reciprocal Openings in Participatory Design and User-Centered Design. Human–Computer Interaction. 2009 Nov 11;11(3):285–290. doi: 10.1207/s15327051hci1103_5.
    1. Bjerkan J, Hedlund M, Hellesø R. Patients' contribution to the development of a web-based plan for integrated care - a participatory design study. Inform Health Soc Care. 2015 Mar;40(2):167–84. doi: 10.3109/17538157.2014.907803.
    1. Clemensen J, Rothmann MJ, Smith AC, Caffery LJ, Danbjorg DB. Participatory design methods in telemedicine research. J Telemed Telecare. 2017 Oct 01;23(9):780–785. doi: 10.1177/1357633X16686747.
    1. Kuhns LM, Hotton AL, Garofalo R, Muldoon AL, Jaffe K, Bouris A, Voisin D, Schneider J. An Index of Multiple Psychosocial, Syndemic Conditions Is Associated with Antiretroviral Medication Adherence Among HIV-Positive Youth. AIDS Patient Care STDS. 2016 Apr;30(4):185–92. doi: 10.1089/apc.2015.0328.
    1. Brooke J. SUS-A quick and dirty usability scale. 1996. [2020-11-26]. .
    1. Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability Scale. International Journal of Human-Computer Interaction. 2008 Jul 30;24(6):574–594. doi: 10.1080/10447310802205776.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006 Jan;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Emanuel EJ, Persad G, Upshur R, Thome B, Parker M, Glickman A, Zhang C, Boyle C, Smith M, Phillips JP. Fair Allocation of Scarce Medical Resources in the Time of Covid-19. N Engl J Med. 2020 May 21;382(21):2049–2055. doi: 10.1056/NEJMsb2005114.
    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.
    1. Mitchell JT, LeGrand S, Hightow-Weidman LB, McKellar MS, Kashuba AD, Cottrell M, McLaurin T, Satapathy G, McClernon FJ. Smartphone-Based Contingency Management Intervention to Improve Pre-Exposure Prophylaxis Adherence: Pilot Trial. JMIR Mhealth Uhealth. 2018 Sep 10;6(9):e10456. doi: 10.2196/10456.
    1. Biello KB, Marrow E, Mimiaga MJ, Sullivan P, Hightow-Weidman L, Mayer KH. 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. JMIR Res Protoc. 2019 Jan 07;8(1):e10694. doi: 10.2196/10694.
    1. Whiteley L, Mena L, Craker LK, Healy MG, Brown LK. Creating a Theoretically Grounded Gaming App to Increase Adherence to Pre-Exposure Prophylaxis: Lessons From the Development of the Viral Combat Mobile Phone Game. JMIR Serious Games. 2019 Mar 27;7(1):e11861. doi: 10.2196/11861.
    1. Kane RL, Johnson PE, Town RJ, Butler M. A structured review of the effect of economic incentives on consumers' preventive behavior. Am J Prev Med. 2004 Nov;27(4):327–52. doi: 10.1016/j.amepre.2004.07.002.
    1. Fehr E, Falk A. Psychological foundations of incentives. European Economic Review. 2002 May;46(4-5):687–724. doi: 10.1016/s0014-2921(01)00208-2.
    1. Gneezy U, Meier S, Rey-Biel P. When and Why Incentives (Don't) Work to Modify Behavior. Journal of Economic Perspectives. 2011 Nov 01;25(4):191–210. doi: 10.1257/jep.25.4.191.

Source: PubMed

3
Tilaa