Same-Day Antiretroviral Therapy Initiation

The Thai Red Cross AIDS Research Centre

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Nittaya Phanuphak, MD, PhD; Phone Number: 881 8253544; Email: nittaya.p@prevention-trcarc.org
• Study Contact Backup: Name: Reshmie Ramautarsing, MD,; Phone Number: +662 2530996; Email: reshmie@prevention-trcarc.org

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50120
    • Sanpatong Hospital
  • Chiang Mai, Thailand, 50300
    • Chiang Mai Hospital
  • Chiang Rai, Thailand, 57000
    • Chiang rai prachanukor Hospital
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Thai Red Cross Aids Research Centre
  • Chiang Mai
    • Hang dong, Chiang Mai, Thailand, 50300
      • Hangdon Hospital
    • Mae Rim, Chiang Mai, Thailand, 50180
      • Nakornping Hospital
    • Saraphi, Chiang Mai, Thailand, 50140
      • Sarapee Hospital
  • Chonburi
    • Bang Lamung, Chonburi, Thailand, 00084
      • Wat Yannasangwararam Hospital
    • Chon Buri, Chonburi, Thailand, 20110
      • Queen Savang Vadhana Memorial Hospital
  • Song Khla
    • Hat Yai, Song Khla, Thailand, 90110
      • Hat Yai Hospital
  • Ubon Ratchathani
    • Udon Thani, Ubon Ratchathani, Thailand, 34000
      • Sunpasitthiprasong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All persons who have tested HIV positive will be examined.

Description

Inclusion Criteria:

1. Thai nationals
2. HIV-positive status
3. Acceptance of Same-Day ART

Exclusion Criteria:

1. not Acceptance of Same-Day ART

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance	Acceptance of Same-Day ART	5 years
Type of Clients	Type of Clients (newly diagnosed or re-engaged)	5 years
Number of clients categorized by demographic characteristics	Demographic Characteristics: age (years), gender (sex at birth and gender identity), risk behavior(s), and reason(s) for HIV testing	5 years
Number of clients with each clinical characteristic	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 years
Number of clients with each ART drug regimen differ from first line ART regimen	Drug regimen, if different from first line drug (TDF, FTC, EFV)	5 years
Duration between date of HIV diagnosis and date of ART initiation	Duration between date of HIV diagnosis and date of ART initiation	5 years
Number of clients with each clinical exclusion criteria	Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs	5 years
Duration between date of ART initiation to date of being successfully transferred and date of ART continuation	Duration of linkage to care, if applicable (date of being successfully transferred and date of ART continuation)	5 years
Retention	Retention (retention in care, discontinued ART, loss to follow-up, death) at month 1, month 3, month 6, and month 12 after ART initiation	5 years
Viral load count	Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)	5 years

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre

Publications and helpful links

General Publications

• Seekaew P, Phanuphak N, Teeratakulpisarn N, Amatavete S, Lujintanon S, Teeratakulpisarn S, Pankam T, Nampaisan O, Jomja P, Prabjunteuk C, Plodgratoke P, Ramautarsing R, Phanuphak P. Same-day antiretroviral therapy initiation hub model at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand: an observational cohort study. J Int AIDS Soc. 2021 Dec;24(12):e25869. doi: 10.1002/jia2.25869.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 1, 2022
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: Same-Day ART Initiation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No