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

• ClinicalTrials.gov Identifier: NCT01900080
• Recruitment Status: Unknown
• First Posted: July 16, 2013
• Last Update Posted: October 11, 2016
• Sponsor: Brigham and Women's Hospital
• Collaborators: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic; Weill Medical College of Cornell University; Harvard Medical School (HMS and HSDM); Florida International University
• Information provided by (Responsible Party): Serena Patricia Koenig, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: July 12, 2013
• First Posted Date: July 16, 2013
• Last Update Posted Date: October 11, 2016
• Study Start Date: August 2013
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 12, 2013)

Retention in care with undetectable viral load [ Time Frame: 12 months after HIV testing ]

Proportion of patients who are alive and in-care with a plasma HIV-1 RNA level <50 copies at 12 months after HIV testing

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 2, 2016)

Adherence to antiretroviral therapy (ART), measured by pharmacy refill records and self-report [ Time Frame: 6 months after ART initiation ]

Comparison of adherence for the first 6 months of ART between the two groups using pharmacy refill records and 3-day self-report

Original Secondary Outcome Measures (submitted: July 12, 2013)

Adherence to antiretroviral therapy (ART), measured by pharmacy refill records [ Time Frame: 6 months after ART initiation ]

Comparison of adherence for the first 6 months of ART between the two groups using pharmacy refill records

Current Other Pre-specified Outcome Measures (submitted: July 2, 2016)

• Cost-effectiveness [ Time Frame: 12 months after HIV testing ]
  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
• Retention with undetectable viral load at <200 copies/ml and <1000 copies/ml cut-off points [ Time Frame: 6 and 12 months after HIV testing ]
  Proportion of participants who are alive and in care with a plasma HIV-1 RNA level <200 copies/ml and <1000 copies/ml
• ART initiation [ Time Frame: 12 months ]
  Proportion of participants who initiate ART during the study period
• Time to Death or LTFU [ Time Frame: 12 months ]
  Median time to death or LTFU

Original Other Pre-specified Outcome Measures (submitted: July 12, 2013)

Cost-effectiveness [ Time Frame: 12 months after HIV testing ]

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

Descriptive Information

• Brief Title: Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
• Official Title: Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care

Brief 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.

Detailed Description

This 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 received 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 received the same services as the same-day ART group (including CD4 cell testing) except that instead of same-day ART, they received 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 took 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 started June 2015), patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3 were included. They are being randomized to receive ART vs. standard pre-ART care. Participants are being enrolled in the study on the same day they receive CD4 count results, which is 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV

Intervention

• 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

Study Arms

• 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
• 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.
  Intervention: Other: Sub-Study: Same-Day ART, CD4 Count >500
• 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.
  Intervention: Other: Sub-Study: Standard Pre-ART Care, CD4 Count >500

• Publications *: Koenig SP, Dorvil N, Dévieux JG, Hedt-Gauthier BL, Riviere C, Faustin M, Lavoile K, Perodin C, Apollon A, Duverger L, McNairy ML, Hennessey KA, Souroutzidis A, Cremieux PY, Severe P, Pape JW. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med. 2017 Jul 25;14(7):e1002357. doi: 10.1371/journal.pmed.1002357. eCollection 2017 Jul.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 10, 2016): 814
• Original Estimated Enrollment (submitted: July 12, 2013): 712
• Estimated Study Completion Date: January 2017
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Note: For the sub-study that includes patients with WHO stage 1 or 2 disease and CD4 count >500, the inclusion and exclusion criteria are the same; only CD4 count is different.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Haiti

Administrative Information

• NCT Number: NCT01900080
• Other Study ID Numbers: AI104344-01A1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Study data will be posted after publication.

• Current Responsible Party: Serena Patricia Koenig, Brigham and Women's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Brigham and Women's Hospital
• Original Study Sponsor: Same as current

Collaborators

• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
• Weill Medical College of Cornell University
• Harvard Medical School (HMS and HSDM)
• 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; Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

• PRS Account: Brigham and Women's Hospital
• Verification Date: October 2016