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
  Purpose

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.


Condition
HIV Testing Rate
Acceptance of Immediate ART

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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

Resource links provided by NLM:


Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

men who have sex with men and transgender women in Thailand

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869595

Contacts
Contact: Nittaya Phanuphak, MD 881 8253544 nittaya.p@trcarc.org
Contact: Siriporn Nonenoy, RN 881 8184143 siriporn.n@searchthailand.org

Locations
Thailand
The Thai Red Cross AIDS Research Centre Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Nittaya Phanuphak, MD    881 825 3544    nittaya.p@trcarc.org   
Contact: Siriporn Nonenoy, NR    881 8184143    siriporn.n@searchthailand.org   
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
National Research Council of Thailand
Ministry of Health, Thailand
The Government Pharmaceutical Organization
National Health Security Office, Thailand
  More Information

No publications provided

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01869595     History of Changes
Other Study ID Numbers: MSM/TG Test and Treat Study
Study First Received: June 1, 2013
Last Updated: October 16, 2014
Health Authority: Thailand: Ministry of Public Health
Thailand: Ethical Committee

Keywords provided by Thai Red Cross AIDS Research Centre:
2000 MSM and TG sites in Bangkok,Lampang,Ubonratchathani

ClinicalTrials.gov processed this record on October 29, 2014