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Addressing the Continuum of Care Among High-risk Thai Men

Addressing the Continuum of Care Among High-risk Thai Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05161689
Enrollment
636
Registered
2021-12-17
Start date
2021-11-27
Completion date
2024-12-25
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, STD

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.

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.

Interventions

BEHAVIORALHUG-M+

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

Sponsors

University of California, San Francisco
CollaboratorOTHER
University of Malaya
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
15 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of HIV Testing in the Past 6 Months Among YMSM at BaselineAssessed at baselineNumber 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 MonthsAssessed at 6 monthsNumber 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 MonthsAssessed at 12 monthsNumber 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 MonthsAssessed at 18 monthsNumber 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 MonthsAssessed at 24 monthsNumber 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 BaselineAssessed at baselineParticipants 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 MonthsAssessed at 6 monthsParticipants 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 MonthsAssessed at 12 monthsParticipants 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 MonthsAssessed at 18 monthsParticipants 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 MonthsAssessed at 24 monthsParticipants 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.

Countries

Thailand

Participant flow

Participants by arm

ArmCount
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. HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
318
Standard of Care
YMSM in this arm will not be exposed to the intervention.
318
Total636

Baseline characteristics

CharacteristicMpowerment-based InterventionStandard of CareTotal
Age, Categorical
<=18 years
56 Participants80 Participants136 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
262 Participants238 Participants500 Participants
Age, Continuous21.1 years
STANDARD_DEVIATION 3.1
20.1 years
STANDARD_DEVIATION 2.6
20.6 years
STANDARD_DEVIATION 2.9
Condom use consistency during anal sex with men over the past 6 months
About half the time
14 Participants8 Participants22 Participants
Condom use consistency during anal sex with men over the past 6 months
Did not have anal sex with men in the past 6 months
186 Participants196 Participants382 Participants
Condom use consistency during anal sex with men over the past 6 months
Every time
76 Participants59 Participants135 Participants
Condom use consistency during anal sex with men over the past 6 months
Less than half the time
9 Participants7 Participants16 Participants
Condom use consistency during anal sex with men over the past 6 months
More than half the time
30 Participants39 Participants69 Participants
Condom use consistency during anal sex with men over the past 6 months
Never
3 Participants9 Participants12 Participants
HIV status data from Ministry of Public Health national database
HIV-negative
126 Participants169 Participants295 Participants
HIV status data from Ministry of Public Health national database
HIV-positive
76 Participants26 Participants102 Participants
HIV status data from Ministry of Public Health national database
Not Found in System
116 Participants123 Participants239 Participants
Number of Participants at Risk of Suicide (SBQ-R)65 Participants79 Participants144 Participants
Number of Participants with Depression (CES-D-10)110 Participants114 Participants224 Participants
Participant has agreed to meet someone contacted online (via app or website) for sex183 Participants191 Participants374 Participants
Participant has given or received items or opportunities in exchange for sex
No
265 Participants269 Participants534 Participants
Participant has given or received items or opportunities in exchange for sex
Yes, I have both given and received money, things, or opportunities
10 Participants6 Participants16 Participants
Participant has given or received items or opportunities in exchange for sex
Yes, I was the one giving money, things, or opportunities
7 Participants2 Participants9 Participants
Participant has given or received items or opportunities in exchange for sex
Yes, I was the one receiving money, things, or opportunities
36 Participants41 Participants77 Participants
Participant has had anal sex with a man while under the influence of drugs or alcohol77 Participants94 Participants171 Participants
Participation in group sex activities (ever)46 Participants61 Participants107 Participants
Race/Ethnicity, Customized
Thai
318 Participants318 Participants636 Participants
Region of Enrollment
Thailand
318 participants318 participants636 participants
Self-Reported Last HIV Testing Date
≤ 6 months ago
92 Participants48 Participants140 Participants
Self-Reported Last HIV Testing Date
7-12 months ago
33 Participants29 Participants62 Participants
Self-Reported Last HIV Testing Date
More than 12 months ago
52 Participants63 Participants115 Participants
Self-Reported Last HIV Testing Date
Never tested
141 Participants178 Participants319 Participants
Sex/Gender, Customized
Self-Identified Sexual/Gender Identity
Bisexual Males
30 Participants15 Participants45 Participants
Sex/Gender, Customized
Self-Identified Sexual/Gender Identity
Males who have sex with Men
285 Participants292 Participants577 Participants
Sex/Gender, Customized
Self-Identified Sexual/Gender Identity
Transwomen who are Biologically Male
3 Participants11 Participants14 Participants
STI Prevalence (Chlamydia and Gonorrhea)58 Participants53 Participants111 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3180 / 318
other
Total, other adverse events
0 / 3180 / 318
serious
Total, serious adverse events
0 / 3180 / 318

Outcome results

Primary

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.

Time frame: Assessed at 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months24 Participants
Standard of CarePrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months40 Participants
Primary

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.

Time frame: Assessed at 18 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months29 Participants
Standard of CarePrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months39 Participants
Primary

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.

Time frame: Assessed at 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months25 Participants
Standard of CarePrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months37 Participants
Primary

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.

Time frame: Assessed at 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months37 Participants
Standard of CarePrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months42 Participants
Primary

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.

Time frame: Assessed at baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline56 Participants
Standard of CarePrevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline63 Participants
Primary

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

Time frame: Assessed at 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months104 Participants
Standard of CarePrevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months98 Participants
Primary

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

Time frame: Assessed at 18 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months96 Participants
Standard of CarePrevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months96 Participants
Primary

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

Time frame: Assessed at 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months61 Participants
Standard of CarePrevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months77 Participants
Primary

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

Time frame: Assessed at 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months114 Participants
Standard of CarePrevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months80 Participants
Primary

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

Time frame: Assessed at baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mpowerment-based InterventionPrevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline92 Participants
Standard of CarePrevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline48 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026