Same-Day Antiretroviral Therapy Initiation

HIV Infections Clinical Trial

Official title:

The Thai Red Cross AIDS Research Centre

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04032028
• Other study ID #: Same-Day ART Initiation
• Status: Active, not recruiting
• Start date: April 1, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2023
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Thai nationals

2. HIV-positive status

3. Acceptance of Same-Day ART

Exclusion Criteria:

1. not Acceptance of Same-Day ART

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Thailand	Wat Yannasangwararam Hospital	Bang Lamung	Chonburi
Thailand	Chiang Mai Hospital	Chiang Mai
Thailand	Sanpatong Hospital	Chiang Mai
Thailand	Chiang rai prachanukor Hospital	Chiang Rai
Thailand	Queen Savang Vadhana Memorial Hospital	Chon Buri	Chonburi
Thailand	Hangdon Hospital	Hang dong	Chiang Mai
Thailand	Hat Yai Hospital	Hat Yai	Song Khla
Thailand	Nakornping Hospital	Mae Rim	Chiang Mai
Thailand	Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok
Thailand	Sarapee Hospital	Saraphi	Chiang Mai
Thailand	Sunpasitthiprasong Hospital	Udon Thani	Ubon Ratchathani

Sponsors (1)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance	Acceptance of Same-Day ART	5 years
Primary	Type of Clients	Type of Clients (newly diagnosed or re-engaged)	5 years
Primary	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
Primary	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
Primary	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
Primary	Duration between date of HIV diagnosis and date of ART initiation	Duration between date of HIV diagnosis and date of ART initiation	5 years
Primary	Number of clients with each clinical exclusion criteria	Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs	5 years
Primary	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
Primary	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
Primary	Viral load count	Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)	5 years