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Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care

NCT01900080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 814

Last updated 2016-10-11

No results posted yet for this study

Summary

The purpose of this study is to determine if same-day HIV testing and antiretroviral therapy (ART) initiation improves retention in care (as measured by the proportion of participants who are alive and in-care with an undetectable viral load 12 months after HIV testing), compared with standard of care (three visits prior to ART initiation). Secondary outcomes include survival, ART initiation, retention in care with viral load \< 200 and \< 1000 copies/ml, 6-month viral load, and adherence as measured by self-report and pharmacy refill records. Enrollment for the main study was completed in October 2015.

In June 2015, enrollment was started for a new sub-study. This sub-study, funded by MAC AIDS, includes patients with WHO stage 1 or 2 disease and CD4 count \>500 cells/mm3. The purpose of the sub-study is to compare 6-month retention for patients who receive same-day ART vs. standard pre-ART care. Secondary outcomes include adherence to INH and Bactrim, and cost-effectiveness between the two groups. Enrollment for the sub-study is ongoing.

Conditions

Interventions

OTHER

Same-Day HIV testing and ART initiation

Same-day HIV testing and ART initiation

OTHER

Standard ART Initiation

Standard ART Initiation

OTHER

Sub-Study: Same-Day ART, CD4 Count >500

Same-day CD4 count and ART initiation for patients with CD4 count \>500 cells/mm3 (CD4 count within 7 days of HIV test)

OTHER

Sub-Study: Standard Pre-ART Care, CD4 Count >500

Standard pre-ART care for patients with CD4 count \>500 cells/mm3

Sponsors & Collaborators

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Florida International University

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Serena P Koenig, MD · Brigham and Women's Hospital

  • Jean W Pape, MD · GHESKIO; Weill Medical College of Cornell University

  • Marie Marcelle Deschamps, MD · Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-06-30
Completion
2017-01-31

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900080 on ClinicalTrials.gov