Thai MSM/TG Test and Treat Study

Study Overview
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Brief Summary
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Objectives To determine the uptake of universal HIV testing among Thai men who have sex with men (MSM) and transgender women (TG) To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among Thai MSM/TG who test positive for HIV Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18 years old, Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test) Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in Lampang and 5-12% in Ubonratchathani.

Detailed Description
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All participants will receive HIV testing at baseline. The frequency of study visits to determine HIV status in HIV-negative participants will be every 6 months for a total follow up time of 24 months. Once HIV-positive status is confirmed, participants will be offered ART immediately regardless of CD4 count. Those who accept ART will be seen more frequently following ART initiation, at 2 weeks, 4 weeks, 2 months, 3 months and every 3 months thereafter until completion of 24 months of follow-up. Those who deny immediate ART will have clinic visits every 6 months to monitor HIV disease. HIV-negative participants will be asked to come for HIV re-testing every 6 months or sooner if they feel exposed to risk

Official Title
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Prospective Study of Study to Evaluate the Feasibility of Universal HIV Testing and Antiretroviral Treatment Regardless of CD4 Count Using the Test and Treat Strategy Among Men Who Have Sex With Men and Transgender Women in Thailand

Conditions
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HIV Testing Rate, Acceptance of Immediate ART

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Thai nationals Age >18 years Men or transgender women who have sex with men Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test) Have signed the consent form Exclusion Criteria: 1. Known HIV-positive serostatus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoints | Proportion of MSM who present for testing who have not previously had an HIV test Proportion of HIV-negative participants who have HIV re-testing over the study period Proportion of HIV-positive participants who accept ART regardless of CD4 count | December 1, 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2000 MSM and TG sites in Bangkok,Lampang,Ubonratchathani