Same-Day Antiretroviral Therapy Initiation
- Conditions
- HIV Infections
- Registration Number
- NCT04032028
- Lead Sponsor
- Thai Red Cross AIDS Research Centre
- Brief Summary
Data from a total of 2,500 walk-in or referred individuals who have been confirmed (diagnosed) HIV positive and accessing care and treatment services at the hospitals targeted by this study will be examined. The starting period for this project is estimated to be the last quarter (Q4) of fiscal year 2018.
- Detailed Description
This 24-month observation study will be conducted in 13 hospitals of 5 provinces in Thailand: Chiang Rai, Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. The research team of TRCARC will collect and analyze secondary and de-identified data from the hospitals' databases. In each site, clients who agree to receive Same-Day ART service will go through standard of care procedures at each hospital, which include: post-test counseling and psychosocial support, baseline lab test, clinical screening, and physical examination. The drug regimen prescribed for clients will mirror the first line ART regimen in Thailand's national guideline, which is tenofovir (TDF), emtricitabine (FTC), and efavirenz (EFV). Retention of the clients will reflect that of the hospital's protocol, and CD4 and viral load will be tested according to the national guideline.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2500
- Thai nationals
- HIV-positive status
- Acceptance of Same-Day ART
- not Acceptance of Same-Day ART
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type of Clients 5 years Type of Clients (newly diagnosed or re-engaged)
Number of clients categorized by demographic characteristics 5 years Demographic Characteristics: age (years), gender (sex at birth and gender identity), risk behavior(s), and reason(s) for HIV testing
Number of clients with each ART drug regimen differ from first line ART regimen 5 years Drug regimen, if different from first line drug (TDF, FTC, EFV)
Number of clients with each clinical exclusion criteria 5 years Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs
Viral load count 5 years Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)
Duration between date of HIV diagnosis and date of ART initiation 5 years Duration between date of HIV diagnosis and date of ART initiation
Duration between date of ART initiation to date of being successfully transferred and date of ART continuation 5 years Duration of linkage to care, if applicable (date of being successfully transferred and date of ART continuation)
Retention 5 years Retention (retention in care, discontinued ART, loss to follow-up, death) at month 1, month 3, month 6, and month 12 after ART initiation
Acceptance 5 years Acceptance of Same-Day ART
Number of clients with each clinical characteristic 5 years Clinical Characteristics based on Thailand's national guidelines (anti-HIV, creatinine, alanine transaminase, syphilis serology, hepatitis B antigen, hepatitis C antibodies, urinalysis, chest X-ray, CD4 count, CDC stage, comorbidity)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Nakornping Hospital
🇹ðŸ‡Mae Rim, Chiang Mai, Thailand
Sanpatong Hospital
🇹ðŸ‡Chiang Mai, Thailand
Hangdon Hospital
🇹ðŸ‡Hang dong, Chiang Mai, Thailand
Sunpasitthiprasong Hospital
🇹ðŸ‡Udon Thani, Ubon Ratchathani, Thailand
Thai Red Cross AIDS Research Centre
🇹ðŸ‡Pathum Wan, Bangkok, Thailand
Wat Yannasangwararam Hospital
🇹ðŸ‡Bang Lamung, Chonburi, Thailand
Queen Savang Vadhana Memorial Hospital
🇹ðŸ‡Chon Buri, Chonburi, Thailand
Chiang Mai Hospital
🇹ðŸ‡Chiang Mai, Thailand
Hat Yai Hospital
🇹ðŸ‡Hat Yai, Song Khla, Thailand
Chiang rai prachanukor Hospital
🇹ðŸ‡Chiang Rai, Thailand
Sarapee Hospital
🇹ðŸ‡Saraphi, Chiang Mai, Thailand