Thai MSM/TG Test and Treat Study

Completed

• Conditions: Acceptance of Immediate ART; HIV Testing Rate

• Registration Number: NCT01869595
• Lead Sponsor: Thai Red Cross AIDS Research Centre

Brief Summary

Objectives

1. To determine the uptake of universal HIV testing among Thai men who have sex with men (MSM) and transgender women (TG)

2. 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

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

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-06-01
• Study First Submitted QC: 2013-06-01
• Study First Posted: 2013-06-05
• Primary Completion: 2019-12
• Study Completion: 2020-11
• Status Verified: 2021-07
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

1. Thai nationals
2. Age >18 years
3. Men or transgender women who have sex with men
4. 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
5. Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)
6. Have signed the consent form

Exclusion Criteria

1. Known HIV-positive serostatus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints	December 1, 2015	* 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

Trial Locations

Locations (1)

The Thai Red Cross AIDS Research Centre; 🇹🇭 Pathum Wan, Bangkok, Thailand