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Active, Not Recruiting

NCT Number: NCT04032028

Same-Day Antiretroviral Therapy Initiation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Thai Red Cross AIDS Research Centre, Pathum Wan, Bangkok, Thailand

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thai nationals
  • HIV-positive status
  • Acceptance of Same-Day ART

Exclusion criteria

  • not Acceptance of Same-Day ART

Treatment and study plan

Primary outcomes

  1. Acceptance

    Time frame: 5 years

    Acceptance of Same-Day ART

  2. Type of Clients

    Time frame: 5 years

    Type of Clients (newly diagnosed or re-engaged)

  3. Number of clients categorized by demographic characteristics

    Time frame: 5 years

    Demographic Characteristics: age (years), gender (sex at birth and gender identity), risk behavior(s), and reason(s) for HIV testing

  4. Number of clients with each clinical characteristic

    Time frame: 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)

  5. Number of clients with each ART drug regimen differ from first line ART regimen

    Time frame: 5 years

    Drug regimen, if different from first line drug (TDF, FTC, EFV)

  6. Duration between date of HIV diagnosis and date of ART initiation

    Time frame: 5 years

    Duration between date of HIV diagnosis and date of ART initiation

  7. Number of clients with each clinical exclusion criteria

    Time frame: 5 years

    Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs

  8. Duration between date of ART initiation to date of being successfully transferred and date of ART continuation

    Time frame: 5 years

    Duration of linkage to care, if applicable (date of being successfully transferred and date of ART continuation)

  9. Retention

    Time frame: 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

  10. Viral load count

    Time frame: 5 years

    Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Registry information

Official study title

The Thai Red Cross AIDS Research Centre

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Jul 25, 2019
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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