HIV/AIDSNCT05161689
Addressing the Continuum of Care Among High-risk Thai Men
A study testing HUG-M+ in people with HIV/AIDS and STD, run by Mahidol University at 2 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 to 29 years, men onlyHealthy volunteers can take part
- What is being tested?
- HUG-M+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- 2 sitesThailand
- Study dates
- 27 Nov 2021to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Do not consent to urine testing or anal swab
- Not willing to give contact information for follow-up assessments
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
M-Health Office Maha Sarakham
Maha Sarakham, 44000
M-Health Office Ubon
Ubon Ratchathani, 34000
About this study
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.
Read the detailed description
The HIV epidemic in Thailand is escalating among young men who have sex with men (YMSM). Particularly, HIV prevalence among YMSM is estimated to be 10-15% in Northeastern Thailand. Obviously high risk sexual behavior is occurring, and the uptake of HIV testing remains low even though free testing services are offered by public clinics. Despite provision of free antiretroviral treatment (ART) by the government, less than 25% of HIV-positive YMSM (HIV+YMSM) are retained in care, suggesting very few have achieved viral suppression. The suboptimal access to HIV testing and treatment services among YMSM pose tremendous challenge in much needed prevention efforts to improve linkage to care and achieve individual and community viral suppression to prevent onward HIV transmission. Community mobilization and an empowerment approach that targets barriers at individual, social/community, and health systems levels are needed to improve access to prevention and treatment services, including sexual risk reduction, HIV testing, and linkage and engagement in the care continuum (CC). Based on a cultural adaptation of the evidence-based Mpowerment intervention, we developed and piloted HUG-M, a multilevel, theory-based intervention that diffuses social support and empowers the YMSM community in order to establish social norms supportive of risk reduction and biannual HIV testing. HUG-M was acceptable to YMSM in a prior pilot study, feasible to implement, and has the potential to increase HIV testing and decrease sexual risk behavior. The proposed study will test a community mobilization, multi-level intervention in two well-matched cities in Northeastern Thailand. The project's aims are: (1) to finalize and manualize HUG-M+, a community mobilization, multicomponent, multi-level, combination intervention that focuses on the entire Continuum of Prevention and Care, (2) to implement HUG-M+ for 2 years in collaboration with the Thailand Ministry of Public Health (MOPH) clinics that provide HIV testing and treatment, and (3) to evaluate the pilot efficacy of HUG-M+ in decreasing sexual risk behavior; increasing HIV testing to at least biannually; and increasing prompt, sustained engagement in care among men living with HIV by (a) longitudinal cohorts of YMSM in two cities in Northeastern Thailand; oversampling HIV+YMSM, which will provide data on the CC including sexual risk behavior; anal bacterial STIs; HIV testing frequency; and engagement in care among HIV+YMSM; and (b) longitudinal public health data, already collected by the MOPH, which include CD4 and viral load data for HIV patients.
- Being tested
- HUG-M+
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUG-M+Behavioural
A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HUG-M+ |
| Standard of care | No intervention | YMSM in this arm will not be exposed to the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start27 Nov 2021
- Primary completion10 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of Malaya, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Thomas E Guadamuz, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161689
- Sponsor's protocol ID
- R01MH119015
- Other IDs
- R01MH119015
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2021
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32842048Guadamuz 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.
PubMed 25750498Guadamuz 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.
PubMed 29691128Guadamuz 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.
PubMed 24989128Kongjareon 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.
PubMed 32160793
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Continuum of Care Among High-risk Thai Men
- ClinicalTrials.gov ID
- NCT05161689
- Acronym / sponsor ID
- R01MH119015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of Malaya, National Institute of Mental Health (NIMH)
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HIV epidemic in Thailand is escalating among young men who have sex with men (YMSM). Particularly, HIV prevalence among YMSM is estimated to be 10-15% in Northeastern Thailand. Obviously high risk sexual behavior is occurring, and the uptake of HIV testing remains low even though free testing services are offered by public clinics. Despite provision of free antiretroviral treatment (ART) by the government, less than 25% of HIV-positive YMSM (HIV+YMSM) are retained in care, suggesting very few have achieved viral suppression. The suboptimal access to HIV testing and treatment services among YMSM pose tremendous challenge in much needed prevention efforts to improve linkage to care and achieve individual and community viral suppression to prevent onward HIV transmission. Community mobilization and an empowerment approach that targets barriers at individual, social/community, and health systems levels are needed to improve access to prevention and treatment services, including sexual risk reduction, HIV testing, and linkage and engagement in the care continuum (CC). Based on a cultural adaptation of the evidence-based Mpowerment intervention, we developed and piloted HUG-M, a multilevel, theory-based intervention that diffuses social support and empowers the YMSM community in order to establish social norms supportive of risk reduction and biannual HIV testing. HUG-M was acceptable to YMSM in a prior pilot study, feasible to implement, and has the potential to increase HIV testing and decrease sexual risk behavior. The proposed study will test a community mobilization, multi-level intervention in two well-matched cities in Northeastern Thailand. The project's aims are: (1) to finalize and manualize HUG-M+, a community mobilization, multicomponent, multi-level, combination intervention that focuses on the entire Continuum of Prevention and Care, (2) to implement HUG-M+ for 2 years in collaboration with the Thailand Ministry of Public Health (MOPH) clinics that provide HIV testing and treatment, and (3) to evaluate the pilot efficacy of HUG-M+ in decreasing sexual risk behavior; increasing HIV testing to at least biannually; and increasing prompt, sustained engagement in care among men living with HIV by (a) longitudinal cohorts of YMSM in two cities in Northeastern Thailand; oversampling HIV+YMSM, which will provide data on the CC including sexual risk behavior; anal bacterial STIs; HIV testing frequency; and engagement in care among HIV+YMSM; and (b) longitudinal public health data, already collected by the MOPH, which include CD4 and viral load data for HIV patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mpowerment-based intervention | Experimental | Behavioral: HUG-M+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. |
| Standard of care | No intervention | –YMSM in this arm will not be exposed to the intervention. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Do not consent to urine testing or anal swab
- Not willing to give contact information for follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUG-M+A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care. | Behavioural | Mpowerment-based intervention |
Primary outcome
Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline
Time frame: Assessed at baseline
Number of Participants who answered "yes" to the question if they have tested in the past 6 months
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months
Time frame: Assessed at 6 months
Number of Participants who answered "yes" to the question if they have tested in the past 6 months
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months
Time frame: Assessed at 12 months
Number of Participants who answered "yes" to the question if they have tested in the past 6 months
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months
Time frame: Assessed at 18 months
Number of Participants who answered "yes" to the question if they have tested in the past 6 months
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months
Time frame: Assessed at 24 months
Number of Participants who answered "yes" to the question if they have tested in the past 6 months
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline
Time frame: Assessed 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.
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months
Time frame: Assessed 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.
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months
Time frame: Assessed 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.
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months
Time frame: Assessed 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.
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months
Time frame: Assessed 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32842048Samoh 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.
- Background: PubMed 25750498Guadamuz 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.
- Background: PubMed 29691128Guadamuz 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.
- Background: PubMed 24989128Guadamuz 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.
- Background: PubMed 32160793Kongjareon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E Guadamuz, PhD principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HUG-M+ in people with HIV/AIDS and STD, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline (time frame: Assessed at baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161689, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.