Same-Day Antiretroviral Therapy Initiation

N/AActive Not RecruitingNCT04032028

Thai Red Cross AIDS Research Centre2,500 enrolled

Overview

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.

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

2,500

Conditions

HIV Infections

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Thai nationals 2. HIV-positive status 3. Acceptance of Same-Day ART Exclusion Criteria: 1\. not Acceptance of Same-Day ART

Locations (11)

Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, Thailand

Wat Yannasangwararam Hospital

Bang Lamung, Changwat Chon Buri, Thailand

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, Thailand

Outcomes

Primary Outcomes

Acceptance

Acceptance of Same-Day ART

Time frame: 5 years

Type of Clients

Type of Clients (newly diagnosed or re-engaged)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 5 years

Duration between date of HIV diagnosis and date of ART initiation

Time frame: 5 years

Number of clients with each clinical exclusion criteria

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

Time frame: 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)

Data from ClinicalTrials.gov

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