Evaluation of a Facility-based Test, Treat, and Prevent HIV Program Among Men Who Have Sex With Men and Transgender Women in Thailand

Completed

• Conditions: PrEP Test and Treat

• Registration Number: NCT02369887
• Lead Sponsor: Thai Red Cross AIDS Research Centre

Brief Summary

This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4 counts, retention in care, and ART adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence and incidence. This study will use similar objectives, indicators, and procedures as those used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations Implementation Science (KPIS) funding through United States Agency for International Development (USAID), in community-based centers, allowing comparison of uptake and follow-up of MSM and TG using the Test and Treat strategy in a variety of settings.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-15
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Primary Completion: 2020-08-15
• Status Verified: 2021-10
• Last Update Submitted: 2023-02-15
• Study Completion: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

• Thai national
• Age >18 year
• Male or transgender women who reports anal intercourse with a man without using a condom at least one time in the past 6 months
• Not known to be HIV-infected
• Able to read and write Thai

Additional inclusion criteria for PrEP:

• A negative HIV test result
• No signs or symptoms of acute HIV infection (fever, sore throat, fatigue, rash, swollen glands, nausea, diarrhea, white spots in the mouth) during the previous month
• Creatinine clearance >60 ml/min
• No contraindication to PrEP medication

Exclusion Criteria

• Participating in community-based Test and Treat study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-Exposure Prophylaxis of HIV	36 months	Participants must be Thai MSM or TG, aged 18 years or older, who report unprotected anal sex with a man during the previous 6 months, can read and write Thai, and are not known to be HIV-infected. To receive PrEP, participants must have a negative HIV test result, no signs or symptoms of acute HIV infection during the previous month, a creatinine clearance result \> 60 ml/min, and no contraindication to PrEP medication.

Trial Locations

Locations (1)

Department of Disease Control (DDC), Ministry of Public Health (MOPH); 🇹🇭 Nonthaburi, Thailand