Clinical trial NCT05262426: Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults
Official title: Optimizing an mHealth Intervention to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Vulnerable Adolescents and Emerging Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-exposure Prophylaxis (PrEP)
HIV Prevention
mHealth
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Wayne State University
name: Institute of HIV Research and Innovation Foundation, Thailand
First posted: 2022-03-02
Enrollment: 145
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.

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). YaCool is a mobile application developed to support transgender women self-management of gender and sexual health, including PrEP use.

In Aim 1, the investigators will begin with needs assessment to evaluate intervention efficacy by exploring the barriers and facilitators of PrEP uptake and adherence through in-depth interviews with transgender women and community health workers. The two interventions will be developed and refined based upon the inputs from transgender women through focus group discussion and community advisory board.

In Aim 2, the investigators will conduct a Multiphase Optimization Strategy (MOST) design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool and to determine whether MES-PrEP works better when combined with Enhanced YaCool to improve PrEP use. Eligible transgender women will be randomized to one of the four experimental conditions, and followed for 12 months with assessments at baseline, month 1, 3, 6, 9 and 12.

Eligibility criteria: Aim 1:

Transgender women participants

Inclusion Criteria:

* Age 16-29 years old
* Male sex at birth
* Self-identifies as woman or transgender women or culturally identifies with the female spectrum
* Confirmed HIV-negative status
* Self-reported recent history of condomless sex in the past 6 months
* Able to understand, read and speak Thai
* Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users) or currently on PrEP with good adherence (Group 3: PrEP users with good adherence).

Exclusion Criteria:

* Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
* Have active suicidal ideation or major mental illness (e.g., untreated psychosis or mania) at the time of interview (patients will be referred for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)

Healthcare providers

Inclusion Criteria:

* Have at least 1-year experience working with HIV-negative transgender women, including providing PrEP prescription and counseling

Exclusion Criteria:

* None

Aim 2:

Inclusion Criteria:

* Age 16-29 years old
* Male sex at birth
* Self-identifies as woman or transgender women or culturally identifies with the female spectrum
* Confirmed HIV-negative status
* Self-reported recent history of condomless sex in the past 6 months
* Able to understand, read and speak Thai
* Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).

Exclusion Criteria:

* Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
* Have active suicidal ideation or major mental illness (e.g., untreated psychosis or mania) at the time of interview (patients will be referred for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
* 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 Acceptability: Exit Interview
timeFrame: Month 1
measure: Intervention Feasibility: Number of responses to text messages
timeFrame: Baseline through Month 12
measure: Intervention Feasibility: Number of intervention sessions completed
timeFrame: Baseline through Month 12
measure: Intervention Feasibility: Participant retention
timeFrame: Baseline through Month 6
measure: PrEP Adherence: Visual analog scale
timeFrame: Baseline through Month 12
measure: PrEP Adherence: Self-reported adherence
timeFrame: Baseline through Month 12
measure: PrEP Adherence: Dried blood spots
timeFrame: Baseline through Month 12
measure: PrEP Uptake
timeFrame: Month 1 through Month 12
Secondary outcomes:
measure: PrEP Knowledge
timeFrame: Baseline to Month 12
measure: HIV Knowledge
timeFrame: Baseline to Month 12
measure: Motivation: Rollnick's Readiness Ruler
timeFrame: Baseline to Month 12
measure: Motivation: Decisional Balance for PrEP Use
timeFrame: Baseline to Month 12
measure: Behavior skills
timeFrame: Baseline to Month 12
measure: HIV Status
timeFrame: Baseline to Month 12
measure: Sexually Transmitted Infections (STIs) Diagnosis
timeFrame: Baseline to Month 12
measure: Sexual Risk
timeFrame: Baseline to Month 12
Other outcomes:
measure: Drug/Alcohol Use: ASSIST
timeFrame: Baseline to Month 12
measure: Drug/Alcohol Use: AUDIT-C
timeFrame: Baseline to Month 12
measure: Mental Health
timeFrame: Baseline to Month 12
measure: Perceived HIV risk
timeFrame: Baseline to Month 12
measure: Social support
timeFrame: Baseline to Month 12
measure: PrEP stigma
timeFrame: Baseline to Month 12
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
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214-22. doi: 10.1016/S1473-3099(12)70315-8. Epub 2012 Dec 21.
citation: Logie CH, Newman PA, Weaver J, Roungkraphon S, Tepjan S. HIV-Related Stigma and HIV Prevention Uptake Among Young Men Who Have Sex with Men and Transgender Women in Thailand. AIDS Patient Care STDS. 2016 Feb;30(2):92-100. doi: 10.1089/apc.2015.0197. Epub 2016 Jan 20.
citation: Ramautarsing RA, Meksena R, Sungsing T, Chinbunchorn T, Sangprasert T, Fungfoosri O, Meekrua D, Sumalu S, Pasansai T, Bunainso W, Wongsri T, Mainoy N, Colby D, Avery M, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Evaluation of a pre-exposure prophylaxis programme for men who have sex with men and transgender women in Thailand: learning through the HIV prevention cascade lens. J Int AIDS Soc. 2020 Jun;23 Suppl 3(Suppl 3):e25540. doi: 10.1002/jia2.25540.
citation: Rael CT, Martinez M, Giguere R, Bockting W, MacCrate C, Mellman W, Valente P, Greene GJ, Sherman S, Footer KHA, D'Aquila RT, Carballo-Dieguez A. Barriers and Facilitators to Oral PrEP Use Among Transgender Women in New York City. AIDS Behav. 2018 Nov;22(11):3627-3636. doi: 10.1007/s10461-018-2102-9.
citation: Wood S, Gross R, Shea JA, Bauermeister JA, Franklin J, Petsis D, Swyryn M, Lalley-Chareczko L, Koenig HC, Dowshen N. Barriers and Facilitators of PrEP Adherence for Young Men and Transgender Women of Color. AIDS Behav. 2019 Oct;23(10):2719-2729. doi: 10.1007/s10461-019-02502-y.
citation: Fuchs JD, Stojanovski K, Vittinghoff E, McMahan VM, Hosek SG, Amico KR, Kouyate A, Gilmore HJ, Buchbinder SP, Lester RT, Grant RM, Liu AY. A Mobile Health Strategy to Support Adherence to Antiretroviral Preexposure Prophylaxis. AIDS Patient Care STDS. 2018 Mar;32(3):104-111. doi: 10.1089/apc.2017.0255.
citation: Songtaweesin WN, Kawichai S, Phanuphak N, Cressey TR, Wongharn P, Saisaengjan C, Chinbunchorn T, Janyam S, Linjongrat D, Puthanakit T; CE-PID - TRC Adolescent Study Team. Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial. J Int AIDS Soc. 2020 Sep;23 Suppl 5(Suppl 5):e25564. doi: 10.1002/jia2.25564.
citation: Naar-King S, Parsons JT, Johnson AM. Motivational interviewing targeting risk reduction for people with HIV: a systematic review. Curr HIV/AIDS Rep. 2012 Dec;9(4):335-43. doi: 10.1007/s11904-012-0132-x.
citation: Bonar EE, Wolfe JR, Drab R, Stephenson R, Sullivan PS, Chavanduka T, Hailu B, Guest JL, Bauermeister J. Training Young Adult Peers in a Mobile Motivational Interviewing-Based Mentoring Approach to Upstream HIV Prevention. Am J Community Psychol. 2021 Mar;67(1-2):237-248. doi: 10.1002/ajcp.12471. Epub 2020 Nov 2.
citation: Dale SK. Using Motivational Interviewing to Increase PrEP Uptake Among Black Women at Risk for HIV: an Open Pilot Trial of MI-PrEP. J Racial Ethn Health Disparities. 2020 Oct;7(5):913-927. doi: 10.1007/s40615-020-00715-9. Epub 2020 Feb 20.
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: 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: Phanuphak N, Anand T, Jantarapakde J, Nitpolprasert C, Himmad K, Sungsing T, Trachunthong D, Phomthong S, Phoseeta P, Tongmuang S, Mingkwanrungruang P, Meekrua D, Sukthongsa S, Hongwiangchan S, Upanun N, Barisri J, Pankam T, Phanuphak P. What would you choose: Online or Offline or Mixed services? Feasibility of online HIV counselling and testing among Thai men who have sex with men and transgender women and factors associated with service uptake. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25118. doi: 10.1002/jia2.25118.
citation: Janamnuaysook R, Guo Y, Yu YJ, Phanuphak N, Kawichai S, MacDonell K, Jupimai T, Rongkavilit C, Wang B. Lived experiences with pre-exposure prophylaxis uptake and adherence among transgender women in Thailand: a qualitative study. Sex Health. 2024 Jan;21:SH23102. doi: 10.1071/SH23102.
citation: MacDonell KK, Wang B, Phanuphak N, Janamnuaysook R, Srimanus P, Rongkavilit C, Naar S. Optimizing an mHealth Intervention to Improve Uptake and Adherence to HIV Pre-exposure Prophylaxis in Young Transgender Women: Protocol for a Multi-Phase Trial. JMIR Res Protoc. 2022 May 19;11(5):e37659. doi: 10.2196/37659.