Clinical trial NCT05243030: Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men
Official title: Adapting Effective mHealth Interventions to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Thai Young Men Who Have Sex With Men (MSM).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-exposure Prophylaxis (PrEP)
HIV Prevention
Mobile health (mHealth)
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Wayne State University
name: Institute of HIV Research and Innovation Foundation, Thailand
First posted: 2022-02-16
Enrollment: 119
Sex: MALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm RCT with 2:1 randomization to MES-PrEP+MTM or standard PrEP Counseling
Primary purpose: PREVENTION

Brief summary: The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).

Detailed description: Motivational Enhancement System for Adherence (MESA) is a computer-based motivation invention, based on the Information-Motivation-Behavioral Skills (IMB) model and Motivational Interviewing (MI) principles, used to promote adherence among HIV-positive youth initiating antiretroviral treatment. In this study, the team will adapt and develop MESA to focus on PrEP uptake and adherence, which will be called Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). Motivational Interactive Text Messaging (MTM) will be integrated with MES-PrEP to provide ongoing support to maintain the individual's motivation for behavior change. Both interventions will be developed and refined based upon the inputs from YMSM through focus group discussion and youth advisory board.

The Investigators propose to pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention combining MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. Eligible YMSM will be randomized to receive either the intervention plus the standard PrEP counseling or standard PrEP counseling, and followed for 6 months with assessments at baseline, month 1, 3 and 6.

Eligibility criteria: Inclusion Criteria:

* Age 16-25 years old
* Men who report sex with men in the past 12 months
* Confirmed HIV-negative status
* Self-reported evidence of being at-risk for HIV acquisition, including one of the following in the past 6 months:

  1. having a sex with an HIV-positive partner
  2. having anal sex
  3. without using a condom
  4. being diagnosed with an STI or
  5. having any illicit drug use (e.g., Amphetamine type stimulants)
* Able to understand, read and speak Thai
* Either having not started PrEP (Group 1: PrEP naive) or currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).

Exclusion Criteria:

* In a mutually monogamous relationship of more than 6 months with a partner who recently tested HIV-negative
* Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
* currently enrolled in another HIV intervention study

Primary outcomes:
measure: Intervention Acceptability: System Usability Score
timeFrame: Month 3
measure: Intervention Acceptability: System Usability Score
timeFrame: Month 6
measure: Intervention Acceptability: Client Satisfaction Questionnaire
timeFrame: Month 3
measure: Intervention Acceptability: Client Satisfaction Questionnaire
timeFrame: Month 6
measure: Intervention Feasibility: Number of responses to text messages
timeFrame: Baseline through Month 6
measure: Intervention Feasibility: Number of intervention sessions completed
timeFrame: Baseline through Month 6
measure: Intervention Feasibility: Participant retention
timeFrame: Baseline through Month 6
measure: PrEP Adherence: Visual analog scale
timeFrame: Baseline through Month 6
measure: PrEP Adherence: Self-reported adherence
timeFrame: Baseline through Month 6
measure: PrEP Adherence: Dried blood spots
timeFrame: Baseline through Month 6
measure: PrEP uptake
timeFrame: Month 1 through Month 6
Secondary outcomes:
measure: PrEP Knowledge
timeFrame: Baseline to Month 6
measure: HIV Knowledge
timeFrame: Baseline to Month 6
measure: Motivation: Rollnick's Readiness Ruler
timeFrame: Baseline to Month 6
measure: Motivation: Decisional Balance for PrEP Use
timeFrame: Baseline to Month 6
measure: Behavioral Skill
timeFrame: Baseline to Month 6
measure: HIV Status
timeFrame: Baseline to Month 6
measure: Sexually Transmitted Infections (STIs) Diagnosis
timeFrame: Baseline to Month 6
measure: Sexual Risk
timeFrame: Baseline to Month 6
Other outcomes:
measure: Mental Health
timeFrame: Baseline to Month 6
measure: PrEP-related Stigma
timeFrame: Baseline to Month 6
measure: Social support
timeFrame: Baseline to Month 6
measure: Perceived HIV risk
timeFrame: Baseline to Month 6
measure: Drug/Alcohol Use: ASSIST
timeFrame: Baseline to Month 6
measure: Drug/Alcohol Use: AUDIT-C
timeFrame: Baseline to Month 6
Locations:
city: Bangkok
country: Thailand
facility: Rainbow Sky Association of Thailand
city: Bangkok
country: Thailand
facility: Institute of HIV Research and Innovation
city: Bangkok
country: Thailand
facility: SWING Foundation
Study officials:
affiliation: University of Massachusetts, Worcester
name: Bo Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colby D, Srithanaviboonchai K, Vanichseni S, Ongwandee S, Phanuphak N, Martin M, Choopanya K, Chariyalertsak S, van Griensven F. HIV pre-exposure prophylaxis and health and community systems in the Global South: Thailand case study. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):19953. doi: 10.7448/IAS.18.4.19953. eCollection 2015.
citation: Phanuphak N, Sungsing T, Jantarapakde J, Pengnonyang S, Trachunthong D, Mingkwanrungruang P, Sirisakyot W, Phiayura P, Seekaew P, Panpet P, Meekrua P, Praweprai N, Suwan F, Sangtong S, Brutrat P, Wongsri T, Na Nakorn PR, Mills S, Avery M, Vannakit R, Phanuphak P. Princess PrEP program: the first key population-led model to deliver pre-exposure prophylaxis to key populations by key populations in Thailand. Sex Health. 2018 Nov;15(6):542-555. doi: 10.1071/SH18065.
citation: Naar-King S, Outlaw AY, Sarr M, Parsons JT, Belzer M, Macdonell K, Tanney M, Ondersma SJ; Adolescent Medicine Network for HIV/AIDS Interventions. Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment. J Pediatr Psychol. 2013 Jul;38(6):638-48. doi: 10.1093/jpepsy/jss132. Epub 2013 Jan 28.
citation: Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.
citation: Horvath T, Azman H, Kennedy GE, Rutherford GW. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009756. doi: 10.1002/14651858.CD009756.
citation: Thienkrua W, van Griensven F, Mock PA, Dunne EF, Raengsakulrach B, Wimonsate W, Howteerakul N, Ungsedhapand C, Chiwarakorn A, Holtz TH. Young Men Who Have Sex with Men at High Risk for HIV, Bangkok MSM Cohort Study, Thailand 2006-2014. AIDS Behav. 2018 Jul;22(7):2137-2146. doi: 10.1007/s10461-017-1963-7.
citation: Wheelock A, Eisingerich AB, Ananworanich J, Gomez GB, Hallett TB, Dybul MR, Piot P. Are Thai MSM willing to take PrEP for HIV prevention? An analysis of attitudes, preferences and acceptance. PLoS One. 2013;8(1):e54288. doi: 10.1371/journal.pone.0054288. Epub 2013 Jan 14.
citation: Seekaew P, Nguyen E, Sungsing T, Jantarapakde J, Pengnonyang S, Trachunthong D, Mingkwanrungruang P, Sirisakyot W, Phiayura P, Panpet P, Meekrua P, Praweprai N, Suwan F, Sangtong S, Brutrat P, Wongsri T, Nakorn PRN, Mills S, Avery M, Vannakit R, Phanuphak P, Phanuphak N. Correlates of nonadherence to key population-led HIV pre-exposure prophylaxis services among Thai men who have sex with men and transgender women. BMC Public Health. 2019 Mar 21;19(1):328. doi: 10.1186/s12889-019-6645-0.
citation: Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, Brookmeyer R. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012 Jul 28;380(9839):367-77. doi: 10.1016/S0140-6736(12)60821-6. Epub 2012 Jul 20.
citation: Chan PA, Mena L, Patel R, Oldenburg CE, Beauchamps L, Perez-Brumer AG, Parker S, Mayer KH, Mimiaga MJ, Nunn A. Retention in care outcomes for HIV pre-exposure prophylaxis implementation programmes among men who have sex with men in three US cities. J Int AIDS Soc. 2016 Jun 13;19(1):20903. doi: 10.7448/IAS.19.1.20903. eCollection 2016.
citation: Schnall R, Travers J, Rojas M, Carballo-Dieguez A. eHealth interventions for HIV prevention in high-risk men who have sex with men: a systematic review. J Med Internet Res. 2014 May 26;16(5):e134. doi: 10.2196/jmir.3393.
citation: Parsons JT, Lelutiu-Weinberger C, Botsko M, Golub SA. A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol. 2014 Feb;82(1):9-18. doi: 10.1037/a0035311. Epub 2013 Dec 23.
citation: Naar-King S, Outlaw A, Green-Jones M, Wright K, Parsons JT. Motivational interviewing by peer outreach workers: a pilot randomized clinical trial to retain adolescents and young adults in HIV care. AIDS Care. 2009 Jul;21(7):868-73. doi: 10.1080/09540120802612824.
citation: Liu AY, Vittinghoff E, von Felten P, Rivet Amico K, Anderson PL, Lester R, Andrew E, Estes I, Serrano P, Brothers J, Buchbinder S, Hosek S, Fuchs JD. Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study. Clin Infect Dis. 2019 May 30;68(12):2010-2017. doi: 10.1093/cid/ciy810.
citation: Dubov A, Altice FL, Fraenkel L. An Information-Motivation-Behavioral Skills Model of PrEP Uptake. AIDS Behav. 2018 Nov;22(11):3603-3616. doi: 10.1007/s10461-018-2095-4.
citation: Badawy SM, Barrera L, Sinno MG, Kaviany S, O'Dwyer LC, Kuhns LM. Text Messaging and Mobile Phone Apps as Interventions to Improve Adherence in Adolescents With Chronic Health Conditions: A Systematic Review. JMIR Mhealth Uhealth. 2017 May 15;5(5):e66. doi: 10.2196/mhealth.7798.
citation: Rongkavilit C, Naar-King S, Kaljee LM, Panthong A, Koken JA, Bunupuradah T, Parsons JT. Applying the information-motivation-behavioral skills model in medication adherence among Thai youth living with HIV: a qualitative study. AIDS Patient Care STDS. 2010 Dec;24(12):787-94. doi: 10.1089/apc.2010.0069. Epub 2010 Nov 22.
citation: van Griensven F, Varangrat A, Wimonsate W, Tanpradech S, Kladsawad K, Chemnasiri T, Suksripanich O, Phanuphak P, Mock P, Kanggarnrua K, McNicholl J, Plipat T. Trends in HIV Prevalence, Estimated HIV Incidence, and Risk Behavior Among Men Who Have Sex With Men in Bangkok, Thailand, 2003-2007. J Acquir Immune Defic Syndr. 2010 Feb;53(2):234-9. doi: 10.1097/QAI.0b013e3181c2fc86.
citation: Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012 Apr 5;14(2):e51. doi: 10.2196/jmir.2015.
citation: Yu YJ, Schieber E, Janamnuaysook R, Wang B, Gunasekar A, MacDonell K, Getwongsa P, Kim D, Wongharn P, Phanuphak N. Barriers and facilitators to pre-exposure prophylaxis (PrEP) uptake and adherence among men who have sex with men (MSM) in Thailand: a qualitative study. AIDS Care. 2024 Aug;36(8):1126-1134. doi: 10.1080/09540121.2024.2332443. Epub 2024 Apr 4.