Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men

Pre-Exposure Prophylaxis Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243030
• Other study ID #: H00023523
• Secondary ID: 1R34MH124081-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: Deogwoon Kim, PhD
• Phone: 8576009425
• Email: Deogwoon.Kim13[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Exposure Prophylaxis

Intervention

Behavioral:
• Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)
MES-PrEP is a two-session computer-delivered intervention based on IMB model. The intervention is tailored based on the person's ratings of perceived importance and confidence of initiating PrEP and sustaining adherence to PrEP. Participants are routed to different intervention content based on their assessment of their importance and confidence. Youth are provided with feedback on scores on the knowledge assessment followed by information about protective effect that can result from improved PrEP adherence. Finally, participants are asked to set a goal: obtain PrEP prescription, optimal adherence, practice steps, or thinking about it more, and they form plans for overcoming barriers. In the second session, branches are based on whether the youth felt they met the goal, partially met the goal, or did not meet the goal. Sessions of MES-PrEP will occur at baseline and month 1.
• Motivational Interactive Text Messaging (MTM)
Participants will receive automated motivational text messages to promote PrEP initiation and adherence. These contents will be customized based on their readiness to change in regards to PrEP. The message content is individualized based on participant response to baseline survey. Those participants who indicate that they are "ready" to set the goal to take PrEP will receive text messages reminding them to take PrEP. Those who indicate that they are less than ready to take their PrEP can choose from a range of alternatives, such as taking on-demand PrEP or just think about taking PrEP. For those who are not ready to take PrEP, the content will be individualized based on the participant's choice, i.e., a daily message encouraging them to work toward their chosen goal. Participants who are currently not on PrEP will receive daily text messages regarding PrEP effectiveness, HIV risk and where to access PrEP.
• Standard PrEP Counseling
All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3 and 6. Standard PrEP counseling includes sexual and behavioral risk assessment for HIV/STIs and risk reduction. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP/post-exposure prophylaxis (PEP) and facilitators and barriers of accessing PrEP. For those on PrEP, the sessions will focus on adherence. Standard counseling sessions will be nonjudgmental, non-discriminatory and client-centered.

Locations

Country	Name	City	State
Thailand	Institute of HIV Research and Innovation	Bangkok
Thailand	Rainbow Sky Association of Thailand	Bangkok
Thailand	SWING Foundation	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Institute of HIV Research and Innovation Foundation, Thailand, National Institute of Mental Health (NIMH), Wayne State University

Country where clinical trial is conducted

Thailand, 

References & Publications (20)

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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. — View 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. — View Citation

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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. — View Citation

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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. — View 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. — View 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. — View 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. — View 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 quali — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mental Health	Mental Health will be assessed using the 12-item Thai General Health Questionnaire. The 4-point Likert scale measures psychological distress such as depression, anxiety, social impartment and somatic complaints. All items are rated on a 4-point Likert scale. The total possible score is 48, with higher scores indicating higher severity of psychological distress.	Baseline to Month 6
Other	PrEP-related Stigma	PrEP-related stigma will be assessed using the 10-item PrEP stigma and positive attitudes scale. The 5-point Likert scale measures opinions about PrEP.	Baseline to Month 6
Other	Social support	Social support will be assessed using the 13-item Social Provision Scale (SPS). The 5-point Likert scale measures the availability of social support, including emotional support, information support, instrumental support, companionship and social isolation. The total possible score is 65, with higher scores indicating greater availability of social support.	Baseline to Month 6
Other	Perceived HIV risk	Perceived HIV risk will be measured using the 8-item Perceived Risk of HIV Scale. Higher scores indicating higher perceived risk for HIV.	Baseline to Month 6
Other	Drug/Alcohol Use: ASSIST	Drug/Alcohol Use will be assessed using Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization (WHO). ASSIST is a questionnaire that is used for identification of substance use related health risks and substance use disorders. Each item ranges from 0-12, with 0 reflecting low risk score. The total possible score is 24, with higher number indicating higher risk of health and other problems based from the current pattern of substance use.	Baseline to Month 6
Other	Drug/Alcohol Use: AUDIT-C	Alcohol Use Disorders Identification Test (AUDIT-C) or a brief alcohol screening instrument will also be used to identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). Each item ranges from 0 to 4, with 0 reflecting no alcohol use. The total possible score is 12, with higher number indicating higher drink above recommended limits and are at increased risks for harm.	Baseline to Month 6
Primary	Intervention Acceptability: System Usability Score	System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of > 50 indicates that the technology-based interventions are acceptable.	Month 3
Primary	Intervention Acceptability: System Usability Score	System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of > 50 indicates that the technology-based interventions are acceptable.	Month 6
Primary	Intervention Acceptability: Client Satisfaction Questionnaire	Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability.	Month 3
Primary	Intervention Acceptability: Client Satisfaction Questionnaire	Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability.	Month 6
Primary	Intervention Feasibility: Number of responses to text messages	Intervention feasibility will be measured by total number of responses to text messages. Point estimates of >50% of participants responded to at least one text message is considered as the minimum criteria for feasibility.	Baseline through Month 6
Primary	Intervention Feasibility: Number of intervention sessions completed	Intervention feasibility will be measured by number of intervention sessions completed. Point estimates of >50% of participants completed at least one intervention session is considered as the minimum criteria for feasibility.	Baseline through Month 6
Primary	Intervention Feasibility: Participant retention	Intervention Feasibility will be measured by participants retention rate at Month 6.	Baseline through Month 6
Primary	PrEP Adherence: Visual analog scale	PrEP adherence will be measured from Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey which contains a visual analog scale (VAS). VAS ranges from 0 to 100, with higher percentage indicating greater adherence to PrEP.	Baseline through Month 6
Primary	PrEP Adherence: Self-reported adherence	PrEP adherence will be measured from self-reported adherence to PrEP in the past 4 weeks.	Baseline through Month 6
Primary	PrEP Adherence: Dried blood spots	PrEP adherence will be measured by the level of tenofovir in dried blood spots (DBS). DBS report on 80% Truvada adherence after at least three weeks of regular adherence.	Baseline through Month 6
Primary	PrEP uptake	PrEP uptake will be measured by the number of PrEP prescription, using a self-report measure (participants reporting if they left the clinic with PrEP) and confirming with clinic records.	Month 1 through Month 6
Secondary	PrEP Knowledge	Knowledge of PrEP will be measured using the 13-item PrEP knowledge scale. The total possible score is 13, with higher scores indicating a greater degree of PrEP knowledge.	Baseline to Month 6
Secondary	HIV Knowledge	Knowledge of HIV transmission risk will be assessed using am 18-item HIV Knowledge Questionnaire. The total possible composite score range from 0 to 18, with higher scores indicating a greater degree of HIV knowledge.	Baseline to Month 6
Secondary	Motivation: Rollnick's Readiness Ruler	Behavioral intentions will be measured using 5-item Rollnick's Readiness Ruler, which correspond to PrEP uptake and adherence. Each item ranges from 0 to 10, with higher numbers indicate greater readiness for change.	Baseline to Month 6
Secondary	Motivation: Decisional Balance for PrEP Use	Attitude towards PrEP will be measured using 36-item Decisional Balance for PrEP Use. The 5-point Likert scale assesses the pros and cons of PrEP use and is helpful in understanding cognitive and motivational aspects of decision making.	Baseline to Month 6
Secondary	Behavioral Skill	Behavior skills will be assessed using the 8-item adapted version of Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. The 5-point Likert scale assesses the confidence in using a condom, taking PrEP as recommended and getting PrEP refills. The total possible score is 40, with higher scores indicating a greater confidence for each item.	Baseline to Month 6
Secondary	HIV Status	HIV status based on 4th generation HIV-1/2 antigen/antibody combo testing.	Baseline to Month 6
Secondary	Sexually Transmitted Infections (STIs) Diagnosis	STI diagnosis based on treponemal test with rapid plasma reagin (RPR) confirmation for syphilis. Pooled urine, oropharyngeal and rectal swabs for gonorrhea and chlamydia nucleic acid amplification test (NAAT) testing.	Baseline to Month 6
Secondary	Sexual Risk	Sexual risk will be assessed through Timeline Followback via CASI, which collects sexual behavior in the past 30 days, including questions about condom use and number of sexual partners.	Baseline to Month 6