Addressing the Continuum of Care Among High-risk Thai Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Addressing the Continuum of Care Among High-risk Thai Men

Conditions
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STD, HIV/AIDS

Intervention / Treatment
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* Behavioral: HUG-M+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mpowerment-based intervention<br>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+<br>* A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.<br>|
| No Intervention: Standard of care<br>YMSM in this arm will not be exposed to the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who have tested for HIV the past 6 months | Participants will answer a yes/no question if they have tested in the past 6 months | 6 months | 
| Number of participants who have engaged in condomless anal intercourse in the past 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who report using PrEP daily or on demand | 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 | Self-reported undetectable viral load | 6 months | 
| HIV prevalence | HIV prevalence at baseline | baseline | 
| HIV incidence/seroconversion | HIV incidence/seroconversion | 6 months | 
| STI incidence | Chlamydia and gonorrhoea by urine and anal swab | 6 months |