PrEP Test and Treat Clinical Trial
— PrEPOfficial title:
Bureau AIDS, TB, and STI, Thailand Ministry of Public Health
| Verified date | October 2021 |
| Source | Thai Red Cross AIDS Research Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 2000 |
| Est. completion date | February 16, 2023 |
| Est. primary completion date | August 15, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Department of Disease Control (DDC), Ministry of Public Health (MOPH) | Nonthaburi |
| Lead Sponsor | Collaborator |
|---|---|
| Thai Red Cross AIDS Research Centre | Ministry of Health, Thailand |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |