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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH119015 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of Malaya | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of care | No Intervention | YMSM in this arm will not be exposed to the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HUG-M+ | Behavioral | A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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. | Assessed at baseline |
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Inclusion Criteria:
Exclusion Criteria:
Since this study is focusing on an HIV key population, namely men who have sex men, participants need to be biological males and identify as males.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E Guadamuz, PhD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M-Health Office Maha Sarakham | Maha Sarakham | 44000 | Thailand | |||
| M-Health Office Ubon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32842048 | Background | 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. | |
| 25750498 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mpowerment-based Intervention | Young men who have sex with men (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. |
| FG001 | Standard of Care | YMSM in this arm will not be exposed to the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Assessed at baseline |
|
Adverse event data were collected over a period of 24-months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chair of the Institutional Review Board | Mahidol University Faculty of Social Sciences and Humanities | +662-441-9180 | mussirb310@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 1, 2020 | Aug 19, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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| 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. |
| 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. | 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. | 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. | Assessed at 24 months |
| Ubon Ratchathani |
| 34000 |
| Thailand |
| 29691128 | Background | 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. |
| 24989128 | Background | 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. |
| 32160793 | Background | 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. |
| BG001 |
| Standard of Care |
YMSM in this arm will not be exposed to the intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-Reported Last HIV Testing Date | Count of Participants | Participants |
|
| HIV status data from Ministry of Public Health national database | Count of Participants | Participants |
|
| Condom use consistency during anal sex with men over the past 6 months | Count of Participants | Participants |
|
| STI Prevalence (Chlamydia and Gonorrhea) | Count of Participants | Participants |
|
| Participation in group sex activities (ever) | Count of Participants | Participants |
|
| Participant has given or received items or opportunities in exchange for sex | Count of Participants | Participants |
|
| Participant has agreed to meet someone contacted online (via app or website) for sex | Count of Participants | Participants |
|
| Participant has had anal sex with a man while under the influence of drugs or alcohol | Count of Participants | Participants |
|
| Number of Participants with Depression (CES-D-10) | Depression was assessed using the 10-item Center for Epidemiologic Studies Depression Scale (CES-D-10), a validated screening tool for depressive symptoms. Each item is rated on a 4-point Likert scale ranging from 0 ("Rarely or none of the time") to 3 ("All of the time"). The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms. A total score of ≥10 was used as the cut-off to classify participants as having depression. The reported outcome reflects the number and percentage of participants meeting this cut-off. | Count of Participants | Participants |
|
| Number of Participants at Risk of Suicide (SBQ-R) | Suicidal risk was assessed using the Suicide Behaviors Questionnaire-Revised (SBQ-R), a validated screening tool for suicidal thoughts and behaviors. The SBQ-R includes 4 items assessing (1) lifetime suicidal ideation and/or attempts, (2) frequency of suicidal ideation in the past 12 months, (3) threats of suicide attempts, and (4) self-reported likelihood of future suicidal behavior. Total scores range from 3 to 18, with higher scores indicating greater risk. Participants with a total score of ≥7 were classified as being at risk of suicide. The reported outcome reflects the number and percent | Count of Participants | 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 | Posted | Count of Participants | Participants | Assessed at 6 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | Assessed at 12 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | Assessed at 18 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | Assessed at 24 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed at baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed at 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed at 12 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed at 18 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed at 24 months |
|
|
|
| 0 |
| 318 |
| 0 |
| 318 |
| 0 |
| 318 |
| EG001 | Standard of Care | YMSM in this arm will not be exposed to the intervention. | 0 | 318 | 0 | 318 | 0 | 318 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |