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

NCT01900080 | Unknown DMC

• 1 other identifier: AI104344-01A1
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; AIDS; Antiretroviral therapy; Retention in care; Adherence; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Retention in care with undetectable viral load

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

  12 months after HIV testing

Secondary Outcomes (1)

• Adherence to antiretroviral therapy (ART), measured by pharmacy refill records and self-report

  6 months after ART initiation

Other Outcomes (4)

• Cost-effectiveness

  12 months after HIV testing

• Retention with undetectable viral load at <200 copies/ml and <1000 copies/ml cut-off points

  6 and 12 months after HIV testing

• ART initiation

  12 months

Study Arms (4)

Same-Day ART Group

EXPERIMENTAL

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

Standard ART Group

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Sub-Study - Pre-ART Care, CD4>500

ACTIVE COMPARATOR

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

Interventions

Same-Day HIV testing and ART initiation OTHER

Same-day HIV testing and ART initiation

Same-Day ART Group

Standard ART Initiation OTHER

Standard ART Initiation

Standard ART Group

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

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

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

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

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

Sub-Study - Pre-ART Care, CD4>500

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• Weill Medical College of Cornell University: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Florida International University: collaborator

Study Sites (1)

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO)

Port-au-Prince, Haiti

Location

Related Publications (1)

• Koenig SP, Dorvil N, Devieux 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.

  PMID: 28742880 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Serena P Koenig, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 16, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

HA (1)