NCT04032028

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

July 2, 2019

Last Update Submit

November 22, 2024

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (10)

  • 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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All persons who have tested HIV positive will be examined.

You may qualify if:

  • Thai nationals
  • HIV-positive status
  • Acceptance of Same-Day ART

You may not qualify if:

  • \. not Acceptance of Same-Day ART

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Wat Yannasangwararam Hospital

Bang Lamung, Changwat Chon Buri, 00084, Thailand

Location

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

Sunpasitthiprasong Hospital

Udon Thani, Changwat Ubon Ratchathani, 34000, Thailand

Location

Hangdon Hospital

Hang Dong, Chiang Mai, 50300, Thailand

Location

Nakornping Hospital

Mae Rim, Chiang Mai, 50180, Thailand

Location

Sarapee Hospital

Saraphi, Chiang Mai, 50140, Thailand

Location

Hat Yai Hospital

Hat Yai, Song Khla, 90110, Thailand

Location

Sanpatong Hospital

Chiang Mai, 50120, Thailand

Location

Chiang Mai Hospital

Chiang Mai, 50300, Thailand

Location

Chiang rai prachanukor Hospital

Chiang Rai, 57000, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 34967504DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 25, 2019

Study Start

April 1, 2018

Primary Completion

July 1, 2022

Study Completion

December 1, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

TH(11)