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Thai MSM/TG Test and Treat Study

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ClinicalTrials.gov Identifier: NCT01869595
Recruitment Status : Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : April 19, 2018
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

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.


Condition or disease
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 [Patient Registry]
Estimated Enrollment : 600 participants
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
Study Start Date : November 2012
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Primary endpoints [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869595


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

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
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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