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Completed

NCT Number: NCT05161689

Addressing the Continuum of Care Among High-risk Thai Men

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections STD Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

M-Health Office Maha Sarakham, Maha Sarakham, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HUG-M+

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of California, San Francisco
  • University of Malaya

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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