Completed

NCT Number: NCT02369887

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

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.

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Key information

Conditions

PrEP Test and Treat

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Disease Control (DDC), Ministry of Public Health (MOPH)

Nonthaburi, 11000, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Pre-Exposure Prophylaxis of HIV

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

Ministry of Health, Thailand

Registry information

Official study title

Bureau AIDS, TB, and STI, Thailand Ministry of Public Health

Acronym: PrEP

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2023
First posted: Feb 24, 2015
Registry last updated: Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.