Clinical trial NCT04032028: Same-Day Antiretroviral Therapy Initiation
Official title: The Thai Red Cross AIDS Research Centre
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All persons who have tested HIV positive will be examined.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. not Acceptance of Same-Day ART

Primary outcomes:
measure: Acceptance
timeFrame: 5 years
measure: Type of Clients
timeFrame: 5 years
measure: Number of clients categorized by demographic characteristics
timeFrame: 5 years
measure: Number of clients with each clinical characteristic
timeFrame: 5 years
measure: Number of clients with each ART drug regimen differ from first line ART regimen
timeFrame: 5 years
measure: Duration between date of HIV diagnosis and date of ART initiation
timeFrame: 5 years
measure: Number of clients with each clinical exclusion criteria
timeFrame: 5 years
measure: Duration between date of ART initiation to date of being successfully transferred and date of ART continuation
timeFrame: 5 years
measure: Retention
timeFrame: 5 years
measure: Viral load count
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Thai Red Cross AIDS Research Centre
state: Bangkok
city: Hang dong
country: Thailand
facility: Hangdon Hospital
state: Chiang Mai
city: Mae Rim
country: Thailand
facility: Nakornping Hospital
state: Chiang Mai
city: Saraphi
country: Thailand
facility: Sarapee Hospital
state: Chiang Mai
city: Bang Lamung
country: Thailand
facility: Wat Yannasangwararam Hospital
state: Chonburi
city: Chon Buri
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
state: Chonburi
city: Hat Yai
country: Thailand
facility: Hat Yai Hospital
state: Song Khla
city: Udon Thani
country: Thailand
facility: Sunpasitthiprasong Hospital
state: Ubon Ratchathani
city: Chiang Mai
country: Thailand
facility: Sanpatong Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai Hospital
city: Chiang Rai
country: Thailand
facility: Chiang rai prachanukor Hospital
Study officials:
References:
citation: 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.