Addressing the Continuum of Care Among High-risk Thai Men

NCT05161689 | Completed Results DMC

• 1 other identifier: R01MH119015
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 2

Brief Summary

Young Thai men who have sex with men (YMSM) are at high risk for HIV. However, the Thailand National HIV Strategy does not adequately cover HIV prevention for YMSM using specific methods relevant to them, and instead uses a one-size-fits all approach. Partnering with the Thailand Ministry of Public Health (MOPH), the proposed study seeks to finalize, implement and evaluate a multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire Continuum of Prevention and Care. The investigators propose to test the efficacy of this approach by conducting research in two Northeastern Thai cities, one randomized to the intervention condition, which will receive HUG-M+ and the other to the control condition, where standard of care will be provided. If HUG-M+ is found to be efficacious, it might be scaled up, with the support of the MOPH, to other regions in Thailand, elsewhere in Asia and the US.

Conditions

HIV/AIDS; STD

Outcome Measures

Primary Outcomes (10)

• Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline

  Number of Participants who answered "yes" to the question if they have tested in the past 6 months

  Assessed at baseline

• Prevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months

  Number of Participants who answered "yes" to the question if they have tested in the past 6 months

  Assessed at 6 months

• Prevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months

  Number of Participants who answered "yes" to the question if they have tested in the past 6 months

  Assessed at 12 months

• Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months

  Number of Participants who answered "yes" to the question if they have tested in the past 6 months

  Assessed at 18 months

• Prevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months

  Number of Participants who answered "yes" to the question if they have tested in the past 6 months

  Assessed at 24 months

• Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline

  Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.

  Assessed at baseline

• Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months

  Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.

  Assessed at 6 months

• Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months

  Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.

  Assessed at 12 months

• Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months

  Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.

  Assessed at 18 months

• Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months

  Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.

  Assessed at 24 months

Study Arms (2)

Mpowerment-based intervention

EXPERIMENTAL

YMSM in this arm may be exposed to a multicomponent, multi-level, community mobilization, combination intervention to address the entire HIV Continuum of Prevention and Care.

Behavioral: HUG-M+

Standard of care

NO INTERVENTION

YMSM in this arm will not be exposed to the intervention.

Interventions

HUG-M+ BEHAVIORAL

A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.

Mpowerment-based intervention

Eligibility Criteria

• Age: 15 Years - 29 Years
• Gender Eligibility Details: Since this study is focusing on an HIV key population, namely men who have sex men, participants need to be biological males and identify as males.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 15-29 years at cohort baseline
• Self-reported male gender
• Self-reported having had anal sex with another man in the past 12 months
• Speak, read and write Thai
• Thai citizenship
• Resident of the assessment city for the next 2 years (live, work or go to school)

You may not qualify if:

• Do not consent to urine testing or anal swab
• Not willing to give contact information for follow-up assessments

Sponsors & Collaborators

• Mahidol University: lead
• University of California, San Francisco: collaborator
• University of Malaya: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

M-Health Office Maha Sarakham

Maha Sarakham, 44000, Thailand

Location

M-Health Office Ubon

Ubon Ratchathani, 34000, Thailand

Location

Related Publications (5)

• Samoh N, Peerawaranun P, Jonas KJ, Lim SH, Wickersham JA, Guadamuz TE. Willingness to Use HIV Self-Testing With Online Supervision Among App-Using Young Men Who Have Sex With Men in Bangkok. Sex Transm Dis. 2021 Mar 1;48(3):e41-e44. doi: 10.1097/OLQ.0000000000001271.

  PMID: 32842048 BACKGROUND

• Guadamuz TE, Goldsamt LA, Boonmongkon P. Consent Challenges for Participation of Young Men Who Have Sex With Men (YMSM) in HIV Prevention Research in Thailand. Ethics Behav. 2015 Mar;25(2):180-195. doi: 10.1080/10508422.2014.949721.

  PMID: 25750498 BACKGROUND

• Guadamuz TE, Boonmongkon P. Ice parties among young men who have sex with men in Thailand: Pleasures, secrecy and risks. Int J Drug Policy. 2018 May;55:249-255. doi: 10.1016/j.drugpo.2018.04.005. Epub 2018 Apr 23.

  PMID: 29691128 BACKGROUND

• Guadamuz TE, McCarthy K, Wimonsate W, Thienkrua W, Varangrat A, Chaikummao S, Sangiamkittikul A, Stall RD, van Griensven F. Psychosocial health conditions and HIV prevalence and incidence in a cohort of men who have sex with men in Bangkok, Thailand: evidence of a syndemic effect. AIDS Behav. 2014 Nov;18(11):2089-96. doi: 10.1007/s10461-014-0826-8.

  PMID: 24989128 BACKGROUND

• Kongjareon Y, Samoh N, Lim SH, Peerawaranun P, Jonas KJ, Guadamuz TE. Group sex, suicidality and online partners: implications for HIV and suicide prevention: a short report. AIDS Care. 2020 Aug;32(8):954-958. doi: 10.1080/09540121.2020.1734174. Epub 2020 Mar 12.

  PMID: 32160793 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Chair of the Institutional Review Board
• Organization: Mahidol University Faculty of Social Sciences and Humanities

mussirb310@gmail.com

+662-441-9180

Study Officials

• Thomas E Guadamuz, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The community-based, multilevel and theory-based intervention diffuses social support and empowers the YMSM community in order to establish social norms supportive of risk reduction and biannual HIV testing.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 17, 2021
• Study Start: November 27, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 25, 2024
• Last Updated: December 26, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)