Clinical trial NCT02369887: Evaluation of a Facility-based Test, Treat, and Prevent HIV Program Among Men Who Have Sex With Men and Transgender Women in Thailand
Official title: Bureau AIDS, TB, and STI, Thailand Ministry of Public Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PrEP Test and Treat
Keywords: MSM/TG who agree to start PrEP
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2015-02-24
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pre-Exposure Prophylaxis of HIV
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Department of Disease Control (DDC), Ministry of Public Health (MOPH)
Study officials:
References:
citation: 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.