HIV/AIDS, STD
Conditions
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
A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 636 |
Baseline characteristics
| Characteristic | Mpowerment-based Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 56 Participants | 80 Participants | 136 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 262 Participants | 238 Participants | 500 Participants |
| Age, Continuous | 21.1 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 Participants | 8 Participants | 22 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 Participants | 196 Participants | 382 Participants |
| Condom use consistency during anal sex with men over the past 6 months Every time | 76 Participants | 59 Participants | 135 Participants |
| Condom use consistency during anal sex with men over the past 6 months Less than half the time | 9 Participants | 7 Participants | 16 Participants |
| Condom use consistency during anal sex with men over the past 6 months More than half the time | 30 Participants | 39 Participants | 69 Participants |
| Condom use consistency during anal sex with men over the past 6 months Never | 3 Participants | 9 Participants | 12 Participants |
| HIV status data from Ministry of Public Health national database HIV-negative | 126 Participants | 169 Participants | 295 Participants |
| HIV status data from Ministry of Public Health national database HIV-positive | 76 Participants | 26 Participants | 102 Participants |
| HIV status data from Ministry of Public Health national database Not Found in System | 116 Participants | 123 Participants | 239 Participants |
| Number of Participants at Risk of Suicide (SBQ-R) | 65 Participants | 79 Participants | 144 Participants |
| Number of Participants with Depression (CES-D-10) | 110 Participants | 114 Participants | 224 Participants |
| Participant has agreed to meet someone contacted online (via app or website) for sex | 183 Participants | 191 Participants | 374 Participants |
| Participant has given or received items or opportunities in exchange for sex No | 265 Participants | 269 Participants | 534 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 Participants | 6 Participants | 16 Participants |
| Participant has given or received items or opportunities in exchange for sex Yes, I was the one giving money, things, or opportunities | 7 Participants | 2 Participants | 9 Participants |
| Participant has given or received items or opportunities in exchange for sex Yes, I was the one receiving money, things, or opportunities | 36 Participants | 41 Participants | 77 Participants |
| Participant has had anal sex with a man while under the influence of drugs or alcohol | 77 Participants | 94 Participants | 171 Participants |
| Participation in group sex activities (ever) | 46 Participants | 61 Participants | 107 Participants |
| Race/Ethnicity, Customized Thai | 318 Participants | 318 Participants | 636 Participants |
| Region of Enrollment Thailand | 318 participants | 318 participants | 636 participants |
| Self-Reported Last HIV Testing Date ≤ 6 months ago | 92 Participants | 48 Participants | 140 Participants |
| Self-Reported Last HIV Testing Date 7-12 months ago | 33 Participants | 29 Participants | 62 Participants |
| Self-Reported Last HIV Testing Date More than 12 months ago | 52 Participants | 63 Participants | 115 Participants |
| Self-Reported Last HIV Testing Date Never tested | 141 Participants | 178 Participants | 319 Participants |
| Sex/Gender, Customized Self-Identified Sexual/Gender Identity Bisexual Males | 30 Participants | 15 Participants | 45 Participants |
| Sex/Gender, Customized Self-Identified Sexual/Gender Identity Males who have sex with Men | 285 Participants | 292 Participants | 577 Participants |
| Sex/Gender, Customized Self-Identified Sexual/Gender Identity Transwomen who are Biologically Male | 3 Participants | 11 Participants | 14 Participants |
| STI Prevalence (Chlamydia and Gonorrhea) | 58 Participants | 53 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 318 | 0 / 318 |
| other Total, other adverse events | 0 / 318 | 0 / 318 |
| serious Total, serious adverse events | 0 / 318 | 0 / 318 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months | 24 Participants |
| Standard of Care | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months | 40 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months | 29 Participants |
| Standard of Care | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months | 39 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months | 25 Participants |
| Standard of Care | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months | 37 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months | 37 Participants |
| Standard of Care | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months | 42 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline | 56 Participants |
| Standard of Care | Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline | 63 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months | 104 Participants |
| Standard of Care | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months | 98 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months | 96 Participants |
| Standard of Care | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months | 96 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months | 61 Participants |
| Standard of Care | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months | 77 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months | 114 Participants |
| Standard of Care | Prevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months | 80 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mpowerment-based Intervention | Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline | 92 Participants |
| Standard of Care | Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline | 48 Participants |