Thai MSM/TG Test and Treat Study

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Testing Rate; Acceptance of Immediate ART

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • The Thai Red Cross AIDS Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

men who have sex with men and transgender women in Thailand

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: National Research Council of Thailand; Ministry of Health, Thailand; National Health Security Office, Thailand; The Government Pharmaceutical Organization

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: June 1, 2013
• First Submitted That Met QC Criteria: June 1, 2013
• First Posted (ESTIMATE): June 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: 2000 MSM and TG sites in Bangkok,Lampang,Ubonratchathani
• Other Study ID Numbers: MSM/TG Test and Treat Study