Clinical trial NCT01869595: Thai MSM/TG Test and Treat Study
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Testing Rate
Acceptance of Immediate ART
Keywords: 2000 MSM and TG sites in Bangkok,Lampang,Ubonratchathani
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
name: Ministry of Health, Thailand
name: The Government Pharmaceutical Organization
name: National Health Security Office, Thailand
First posted: 2013-06-05
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: men who have sex with men and transgender women in Thailand

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.

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 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

Primary outcomes:
measure: Primary endpoints
timeFrame: December 1, 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
state: Bangkok
Study officials:
References: