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临床试验/NCT05161689
NCT05161689已完成不适用

Addressing the Continuum of Care Among High-risk Thai Men

Mahidol University4 个研究点 分布在 1 个国家目标入组 636 人开始时间: 2021年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
636
试验地点
4
主要终点
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 29 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • Do not consent to urine testing or anal swab
  • Not willing to give contact information for follow-up assessments

结局指标

主要结局

Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months

时间窗: 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 Baseline

时间窗: 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

时间窗: 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

时间窗: 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 24 Months

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline

时间窗: Assessed at baseline

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 6 Months

时间窗: 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 HIV Testing in the Past 6 Months Among YMSM at 6 Months

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 12 Months

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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