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CompletedNCT02369887PrEPUpdated Feb 17, 2023

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

An observational study in PrEP Test and Treat, sponsored by Thai Red Cross AIDS Research Centre. Completed at 1 site in Thailand. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by Thai Red Cross AIDS Research Centre · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years to 60 Years
Sex
Male
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Study 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.

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Conditions studied

  • PrEP Test and Treat

Keywords

  • MSM/TG who agree to start PrEP
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In context

Lead sponsor

Thai Red Cross AIDS Research Centre is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Participating in community-based Test and Treat study
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,000 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
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What researchers measure

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.

    Time frame: 36 months

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Study locations

1 site
  • Department of Disease Control (DDC), Ministry of Public Health (MOPH)
    Nonthaburi, 11000, Thailand
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References and documents

Publications

  • 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. PubMed 30033559 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02369887
Lead sponsor
Thai Red Cross AIDS Research Centre
Collaborators
Ministry of Health, Thailand
Responsible party
Sponsor
First posted
Feb 24, 2015
Start date
Sep 15, 2014
Primary completion
Aug 15, 2020
Completion
Feb 16, 2023
Last update
Feb 17, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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