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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 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: June 7, 2015
Last verified: June 2015
  Purpose

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.

In June 2015, enrollment is anticipated for a new sub-study. This sub-study, funded by MAC AIDS, will include 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.


Condition Intervention
HIV
Other: Same-Day HIV testing and ART initiation
Other: Standard ART Initiation
Other: Sub-Study: Same-Day ART, CD4 Count >500
Other: Sub-Study: Standard Pre-ART Care, CD4 Count >500

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 888
Study Start Date: August 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other: Same-Day HIV testing and ART initiation
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.

Other: Standard ART Initiation
Standard ART Initiation
Experimental: Sub-Study - Same-Day ART, CD4>500
Sub-Study - Same-Day CD4 Count and ART Initiation for Patients with CD4 Count >500 cells/mm3: Participants will receive counseling and start ART on the day of study enrollment. They will have follow-up visits with the physician on Days 3, 10, 17, and 24, and with the social worker on Days 3, 10, and 17. They will have also have physician visits at weeks 8 and 12. Participants who are clinically stable, asymptomatic, and adherent at week 12 will then qualify for expedited care at future visits, which includes dispensing of ART directly by nurses in the clinic every four weeks, to reduce waiting time for patients. Participants who are symptomatic or non-adherent will be referred to a physician for evaluation.
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)
Active Comparator: Sub-Study - Pre-ART Care, CD4>500
Participants will receive standard GHESKIO pre-ART care, which includes a monthly visit with a physician for 3 months, and then every other month physician visits.
Other: Sub-Study: Standard Pre-ART Care, CD4 Count >500
Standard pre-ART care for patients with CD4 count >500 cells/mm3

Detailed Description:

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 ≤500 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.

In a sub-study funded by MAC AIDS Foundation (enrollment planned in June 2015), patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3 will be included. They will be randomized to receive ART vs. standard pre-ART care. Participants will be enrolled in the study on the same day they receive CD4 count results, which will be within 7 days of the date of HIV testing. All patients will receive additional tests as clinically indicated. All participants will receive prophylactic treatment with trimethoprim-sulfamethoxazole and isoniazid, and a daily multivitamin, as is standard of care at GHESKIO. Participants who are randomized to the standard pre-ART group will receive standard GHESKIO pre-ART care, which includes a monthly visit with a physician for 3 months, and then every other month physician visits. They will have a CD4 count annually, and start ART when they meet WHO criteria. Participants who are randomized to the same-day ART group will receive counseling and start ART on the day of study enrollment. They will have follow-up visits with the physician on Days 3, 10, 17, and 24, and with the social worker on Days 3, 10, and 17. They will have also have physician visits at weeks 8 and 12. Participants who are clinically stable, asymptomatic, and adherent at week 12 will then qualify for expedited care at future visits, which includes dispensing of ART directly by nurses in the clinic every four weeks, to reduce waiting time for patients. Participants who are symptomatic or non-adherent will be referred to a physician for evaluation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years;
  • Ability and willingness of participant to give written informed consent;
  • CD4 cell count </=500 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900080

Contacts
Contact: Jean W Pape, MD 011 509 2940 1430 jwpape@gheskio.org
Contact: Serena P Koenig, MD 617-413-4090 skoenig@partners.org

Locations
Haiti
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO) Recruiting
Port-au-Prince, Haiti
Contact: Nancy Dorvil, MD    011 509 2940 1430    dorvilnancy@gheskio.org   
Contact: Daphne Bernard, MD    011 509 2940 1430    dbernard@gheskio.org   
Principal Investigator: Jean W Pape, MD         
Principal Investigator: Patrice Severe, PI         
Sub-Investigator: Nancy Dorvil, MD         
Principal Investigator: Marie Marcelle Deschamps, MD         
Sub-Investigator: Cynthia Riviere, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
GHESKIO
Weill Medical College of Cornell University
Harvard Medical School
Florida International University
Investigators
Principal Investigator: Serena P Koenig, MD Brigham and Women's Hospital
Study Director: Jean W Pape, MD GHESKIO; Weill Medical College of Cornell University
Study Director: Marie Marcelle Deschamps, MD GHESKIO
  More Information

No publications provided

Responsible Party: Serena Patricia Koenig, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01900080     History of Changes
Other Study ID Numbers: AI104344-01A1
Study First Received: July 12, 2013
Last Updated: June 7, 2015
Health Authority: Haiti: Institutional Review Board
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
HIV
AIDS
Antiretroviral therapy
Retention in care
Adherence
Cost-effectiveness

ClinicalTrials.gov processed this record on June 30, 2015