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

NCT02369887 | Completed DMC

• 1 other identifier: Test and Treat PrEP
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Test and Treat

Keywords

MSM/TG who agree to start PrEP

Outcome Measures

Primary Outcomes (1)

• Pre-Exposure Prophylaxis of HIV

  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.

  36 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Thai nationals not known to be HIV-infected aged ≥18 years old who are men or transgender women who report unprotected anal sex with a man in the past 6 months and are eligible for the study.

You may qualify if:

• 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
• 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

You may not qualify if:

• Participating in community-based Test and Treat study

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

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

Nonthaburi, 11000, Thailand

Location

Related Publications (1)

• Suraratdecha C, Stuart RM, Manopaiboon C, Green D, Lertpiriyasuwat C, Wilson DP, Pavaputanon P, Visavakum P, Monkongdee P, Khawcharoenporn T, Tharee P, Kittinunvorakoon C, Martin M. Cost and cost-effectiveness analysis of pre-exposure prophylaxis among men who have sex with men in two hospitals in Thailand. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25129. doi: 10.1002/jia2.25129.

  PMID: 30033559 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 24, 2015
• Study Start: September 15, 2014
• Primary Completion: August 15, 2020
• Study Completion: February 16, 2023
• Last Updated: February 17, 2023

Record last verified: 2021-10

Locations

TH (1)