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Rapid HIV Treatment Initiation, Access and Engagement in Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512964
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : November 29, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The investigators propose to evaluate Rapid HIV Treatment Initiation in Baltimore in newly and previously diagnosed HIV-positive patients not in care through identification of barriers, facilitators and acceptability of Rapid HIV Treatment Initiation among newly and previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East Baltimore campus and at the Baltimore City Health Department sexually transmitted disease clinics. Using this data, a protocol for Rapid HIV Treatment Initiation among newly and previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East Baltimore campus and the Baltimore City Health Department sexually transmitted disease clinics will be developed and pilot tested. This pilot data will be used to design a multi-site study evaluating the effectiveness of Rapid HIV Treatment Initiation versus facilitated linkage to care. A model for Rapid HIV Treatment Initiation in Baltimore could be generalized to cities where the HIV epidemic has a similar demographic and risk profile such as Washington DC, Atlanta, and New York City.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Drug: dolutegravir and descovy Phase 2

Detailed Description:
Prompt initiation of antiretroviral therapy to achieve and sustain viral suppression decreases the morbidity and mortality of HIV and greatly reduces the risk of transmission yet gaps in the care cascade persist. At current testing and treatment rates, an estimated 524,000 new infections and 375,000 deaths will occur between 2015 and 2025 in the US. Rates of HIV are unacceptably high among African Americans and men who have sex with men and a majority of new transmissions originate from patients previously diagnosed but not in care. To curb rates of infection and improve HIV-related outcomes, cities such as Baltimore, where the HIV epidemic predominately affects African Americans and men who have sex with men, must implement more effective ways to identify and treat all individuals with HIV. Compressing the treatment timeline by starting antiretroviral therapy at the time of diagnosis is known as rapid HIV treatment initiation. Early studies of Rapid HIV Treatment Initiation in newly diagnosed patients in South Africa and San Francisco showed significant improvement in care linkage, antiretroviral therapy initiation and time to viral suppression. Investigators propose to evaluate Rapid HIV Treatment Initiation in Baltimore in newly and previously diagnosed HIV-positive patients not in care through identification of barriers, facilitators and acceptability of Rapid HIV Treatment Initiation and pilot testing a protocol for Rapid HIV Treatment Initiation among newly and previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East Baltimore campus and at the Baltimore City Health Department sexually transmitted disease clinics. This pilot data will be used to design a multi-site study evaluating the effectiveness of Rapid HIV Treatment Initiation versus facilitated linkage to care. A model for Rapid HIV Treatment Initiation in Baltimore could be generalized to cities where the HIV epidemic has a similar demographic and risk profile such as Washington DC, Atlanta, and New York City.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Rapid HIV Treatment Initiation, Access and Engagement in Care (RHAE)
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : May 13, 2020
Estimated Study Completion Date : May 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Rapid HIV Treatment Initiation
Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months.
Drug: dolutegravir and descovy
Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.




Primary Outcome Measures :
  1. Number of patients who receive rapid HIV treatment initiation [ Time Frame: 12 months ]
    Number of people who do start Anti-retroviral Therapy (ART) the same day it is offered


Secondary Outcome Measures :
  1. Rapid HIV Treatment Initiation Acceptability [ Time Frame: 12 months ]
    Number of people who respond yes to starting ART same day vs. those who respond no in the survey

  2. Number of patients offered rapid HIV treatment initiation [ Time Frame: 12 months ]
    Number of people offered to start ART same day

  3. Number of patients accepted rapid HIV treatment initiation [ Time Frame: 12 months ]
    number of people who do start ART the same day it is offered



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 to 65 years of age
  • English speaking
  • Patients identified in the Hopkins Emergency Department, Hopkins John G. Bartlett Specialty Practice clinic or Baltimore City Health Department sexually transmitted disease clinics who are newly diagnosed with HIV (test positive by 3rd or 4th generation HIV test or detectable HIV viral load with no previously documented positive HIV test by medical record and/or self-report) and patients with previous HIV diagnosis but by self-report are not in care and not on antiretroviral therapy (> six months without HIV care or antiretroviral therapy)

Exclusion Criteria:

  • Women who are currently pregnant or planning on becoming pregnant
  • Adults lacking the capacity to consent
  • Patients referred to HIV care outside of Johns Hopkins and/or Baltimore City Health Department Sexually Transmitted Diseases (STD) clinics
  • Patients with estimated creatinine clearance <30 mL/min at last documented laboratory testing in the available medical record at site of referral, self-report of chronic kidney disease without documented creatinine within the last three months
  • Patients who have pre-study documented HIV resistance mutations to dolutegravir or tenofovir alafenamide in the available medical record at site of referral or who self-report history of HIV resistance mutations. and susceptibility to dolutegravir and tenofovir alafenamide cannot be confirmed
  • Patients with a contraindication to dolutegravir, tenofovir alafenamide and/or emtricitabine
  • Patients on or in anticipation of starting a rifamycin medication (rifampin, rifabutin, or rifapentine) and/or carbamazepine
  • Patients judged by clinic or study staff to be physically or emotionally unable to provide consent or participate in all study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512964


Contacts
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Contact: Joyce Jones, MD 917-696-9941 jjone154@jhmi.edu
Contact: Christina Bunch, MS 410-614-2203 cbunch1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nicholas LaBricciosa    410-614-0284    nlabric1@jhmi.edu   
Principal Investigator: Joyce Jones, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Joyce Jones, MD JohnsHopkins U

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03512964    
Other Study ID Numbers: IRB00110075
P30AI094189 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents