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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05161689
Other study ID # R01MH119015
Secondary ID R01MH119015
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 27, 2021
Est. completion date May 31, 2025

Study information

Verified date May 2024
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Thailand M-Health Office Maha Sarakham Maha Sarakham
Thailand M-Health Office Ubon Ubon Ratchathani

Sponsors (4)

Lead Sponsor Collaborator
Mahidol University National Institute of Mental Health (NIMH), University of California, San Francisco, University of Malaya

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who have tested for HIV the past 6 months Participants will answer a yes/no question if they have tested in the past 6 months 6 months
Primary Number of participants who have engaged in condomless anal intercourse in the past 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. 6 months
Secondary Number of participants who report using PrEP daily or on demand Participants will answer a series of questions related to PrEP use and patterns of use (either daily or on demand) 6 months
Secondary Undetectable viral load Self-reported undetectable viral load 6 months
Secondary HIV prevalence HIV prevalence at baseline baseline
Secondary HIV incidence/seroconversion HIV incidence/seroconversion 6 months
Secondary STI incidence Chlamydia and gonorrhoea by urine and anal swab 6 months
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