Thai MSM/TG Test and Treat Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Thai Red Cross AIDS Research Centre
Sponsor:
Collaborators:
National Research Council of Thailand
Ministry of Health, Thailand
The Government Pharmaceutical Organization
National Health Security Office, Thailand
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT01869595
First received: June 1, 2013
Last updated: October 16, 2014
Last verified: October 2014

June 1, 2013
October 16, 2014
November 2012
November 2017   (final data collection date for primary outcome measure)
Primary endpoints [ Time Frame: December 1, 2015 ] [ Designated as safety issue: Yes ]
  • 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
Same as current
Complete list of historical versions of study NCT01869595 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

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

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Not Provided
Probability Sample

men who have sex with men and transgender women in Thailand

  • HIV Testing Rate
  • Acceptance of Immediate ART
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
November 2020
November 2017   (final data collection date for primary outcome measure)

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

Male
18 Years to 90 Years
Yes
Contact: Nittaya Phanuphak, MD 881 8253544 nittaya.p@trcarc.org
Contact: Siriporn Nonenoy, RN 881 8184143 siriporn.n@searchthailand.org
Thailand
 
NCT01869595
MSM/TG Test and Treat Study
Yes
Thai Red Cross AIDS Research Centre
Thai Red Cross AIDS Research Centre
  • National Research Council of Thailand
  • Ministry of Health, Thailand
  • The Government Pharmaceutical Organization
  • National Health Security Office, Thailand
Not Provided
Thai Red Cross AIDS Research Centre
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP