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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
GHESKIO
Weill Medical College of Cornell University
Harvard Medical School
Florida International University
Information provided by (Responsible Party):
Serena Patricia Koenig, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01900080
First received: July 12, 2013
Last updated: November 16, 2013
Last verified: July 2013

July 12, 2013
November 16, 2013
August 2013
August 2015   (final data collection date for primary outcome measure)
Retention in care with undetectable viral load [ Time Frame: 12 months after HIV testing ] [ Designated as safety issue: No ]
Proportion of patients who are alive and in-care with a plasma HIV-1 RNA level <50 copies at 12 months after HIV testing
Same as current
Complete list of historical versions of study NCT01900080 on ClinicalTrials.gov Archive Site
Adherence to antiretroviral therapy (ART), measured by pharmacy refill records [ Time Frame: 6 months after ART initiation ] [ Designated as safety issue: No ]
Comparison of adherence for the first 6 months of ART between the two groups using pharmacy refill records
Same as current
Cost-effectiveness [ Time Frame: 12 months after HIV testing ] [ Designated as safety issue: No ]
To compare the cost and cost-effectiveness of standard and same-day ART, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with a plasma HIV-1 RNA level <50 copies/ml at 12 months after HIV testing
Same as current
 
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care

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 comparisons of 6-month adherence and cost-effectiveness between the two groups.

The proposed study is a randomized trial to establish the effectiveness of same-day ART initiation for patients who present for HIV testing with early HIV clinical disease (World Health Organization [WHO] stage 1 or 2) who qualify for ART by immunologic criteria (CD4 cell count ≤350 cells/mm3) with rapid CD4 cell testing at the GHESKIO Center in Port-au-Prince, Haiti. All patients in the intervention group will receive rapid HIV antibody testing, CD4 cell testing, clinically relevant testing for opportunistic infections, WHO staging, comprehensive counseling and social support, and ART initiation on the day of presentation. The standard group will receive the same services as the same-day ART group (including CD4 cell testing) except that instead of same-day ART, they will receive the standard GHESKIO protocol of three sequential visits for ART readiness counseling and testing for opportunistic infections prior to ART initiation. For the same-day ART group, these activities will take place on the day of ART initiation and during the subsequent two weeks. Three specific aims are proposed. The first aim is to compare the proportion of patients in the standard and same-day ART groups that are alive and in-care with an undetectable HIV viral load at 12 months after HIV testing. The second aim is to compare six-month ART adherence between the two groups using pharmacy refill records. The third aim is to compare the cost and cost-effectiveness of standard and same-day ART, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with an undetectable viral load at 12 months after HIV testing.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Other: Same-Day HIV testing and ART initiation
    Same-day HIV testing and ART initiation
  • Other: Standard ART Initiation
    Standard ART Initiation
  • Experimental: Same-Day ART Group

    Same-Day HIV testing and ART initiation:

    All participants in the same-day ART group will receive rapid HIV antibody testing, CD4 cell testing, clinically relevant testing for OIs, WHO staging, counseling and social support, and ART initiation on the day of presentation for HIV testing.

    Intervention: Other: Same-Day HIV testing and ART initiation
  • Active Comparator: Standard ART Group

    Standard ART Initiation:

    The standard group will receive the same services as the same-day ART group (including same-day HIV and CD4 cell testing) except that instead of same-day ART, they will receive the standard GHESKIO protocol of 3 sequential visits for ART readiness counseling and testing for OIs prior to ART initiation.

    Intervention: Other: Standard ART Initiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
712
Not Provided
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥18 years;
  • Ability and willingness of participant to give written informed consent;
  • CD4 cell count </=350 cells/mm3
  • WHO stage 1 or 2 disease as defined by the following conditions: Asymptomatic; Persistent generalized lymphadenopathy; Moderate unexplained weight loss (under 10% of presumed or measured body weight); Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis); Herpes zoster; Angular cheilitis; Recurrent oral ulcerations; Papular pruritic eruptions; Seborrheic dermatitis; Fungal nail infections

Exclusion Criteria:

  • Any use of ART in the past;
  • Pregnancy or breastfeeding at the screening visit;
  • Psychologically unprepared to start ART, based on ART readiness survey;
  • Plans to transfer care to another clinic during the study period;
  • WHO stage 3 or 4 disease.
Both
18 Years and older
No
Contact: Jean W Pape, MD 011 509 2940 1430 jwpape@gheskio.org
Contact: Serena P Koenig, MD 617-413-4090 skoenig@partners.org
Haiti
 
NCT01900080
AI104344-01A1
Yes
Serena Patricia Koenig, Brigham and Women's Hospital
Brigham and Women's Hospital
  • GHESKIO
  • Weill Medical College of Cornell University
  • Harvard Medical School
  • Florida International University
Principal Investigator: Serena P Koenig, MD Brigham and Women's Hospital
Study Director: Jean W Pape, MD GHESKIO; Weill Medical College of Cornell University
Brigham and Women's Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP