Addressing the Continuum of Care Among High-risk Thai Men

December 8, 2025 updated by: Mahidol University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
636

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
      • Maha Sarakham, Thailand, 44000
        • M-Health Office Maha Sarakham
      • Ubon Ratchathani, Thailand, 34000
        • M-Health Office Ubon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mpowerment-based intervention
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+
A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
No Intervention: Standard of care
YMSM in this arm will not be exposed to the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Assessed at baseline
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.
Assessed at 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.
Assessed at 12 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.
Assessed at 18 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.
Assessed at 24 months
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
Assessed at baseline
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
Assessed at 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
Assessed at 12 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
Assessed at 18 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
Assessed at 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants who report using PrEP daily or on demand
Time Frame: 6 months
Participants will answer a series of questions related to PrEP use and patterns of use (either daily or on demand)
6 months
Undetectable viral load
Time Frame: 6 months
Self-reported undetectable viral load
6 months
HIV prevalence
Time Frame: baseline
HIV prevalence at baseline
baseline
HIV incidence/seroconversion
Time Frame: 6 months
HIV incidence/seroconversion
6 months
STI incidence
Time Frame: 6 months
Chlamydia and gonorrhoea by urine and anal swab
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University of Malaya
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas E Guadamuz, PhD, Mahidol university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH119015 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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