Thai MSM/TG Test and Treat Study

Acceptance of Immediate ART Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869595
• Other study ID #: MSM/TG Test and Treat Study
• Status: Completed
• Start date: November 2012
• Est. completion date: November 2020

Study information

• Verified date: July 2021
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acceptance of Immediate ART
• HIV Testing Rate

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Ministry of Health, Thailand, National Health Security Office, Thailand, National Research Council of Thailand, The Government Pharmaceutical Organization

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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