HIV InfectionsNCT04032028
Same-Day Antiretroviral Therapy Initiation
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 11 sites in Thailand.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- How many people
- 2,500 participants
- Where
- 11 sitesThailand
- Study dates
- 1 Apr 2018to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All persons who have tested HIV positive will be examined.
Who may be able to join
- Thai nationals
- HIV-positive status
- Acceptance of Same-Day ART
Who cannot join
- 1. not Acceptance of Same-Day ART
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Thailand11 sites
Wat Yannasangwararam Hospital
Bang Lamung, Changwat Chon Buri, 00084
Sanpatong Hospital
Chiang Mai, 50120
Chiang Mai Hospital
Chiang Mai, 50300
Chiang rai prachanukor Hospital
Chiang Rai, 57000
Queen Savang Vadhana Memorial Hospital
Chon Buri, Changwat Chon Buri, 20110
Hangdon Hospital
Hang Dong, Chiang Mai, 50300
Hat Yai Hospital
Hat Yai, Song Khla, 90110
Nakornping Hospital
Mae Rim, Chiang Mai, 50180
Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
Sarapee Hospital
Saraphi, Chiang Mai, 50140
Sunpasitthiprasong Hospital
Udon Thani, Changwat Ubon Ratchathani, 34000
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance
Acceptance of Same-Day ART
Measured: 5 years
Type of Clients
Type of Clients (newly diagnosed or re-engaged)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 5 years
Duration between date of HIV diagnosis and date of ART initiation
Duration between date of HIV diagnosis and date of ART initiation
Measured: 5 years
Number of clients with each clinical exclusion criteria
Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs
Measured: 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)
Measured: 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
Measured: 5 years
Viral load count
Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Apr 2018
- Primary completion1 Jul 2022
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032028
- Sponsor's protocol ID
- Same-Day ART Initiation
- Status last verified
- Nov 2024
- First submitted
- 2 Jul 2019
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34967504
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thai Red Cross AIDS Research Centre
- ClinicalTrials.gov ID
- NCT04032028
- Acronym / sponsor ID
- Same-Day ART Initiation
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All persons who have tested HIV positive will be examined.
Key inclusion criteria (3 listed)
- Thai nationals
- HIV-positive status
- Acceptance of Same-Day ART
Key exclusion criteria (1 listed)
- 1. not Acceptance of Same-Day ART
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptance
Time frame: 5 years
Acceptance of Same-Day ART
Type of Clients
Time frame: 5 years
Type of Clients (newly diagnosed or re-engaged)
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
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)
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)
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
Number of clients with each clinical exclusion criteria
Time frame: 5 years
Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs
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)
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
Viral load count
Time frame: 5 years
Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 34967504Seekaew 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 11 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance (time frame: 5 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.