Rapid HIV Treatment Initiation, Access and Engagement in Care
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

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.
    

Intervention name(s): Dolutegravir 50 MG; Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY]
Intervention type(s): Drug; Drug
Intervention description(s): 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. 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.; 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 emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy) 1 tablet by mouth daily. 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.
Other intervention name(s): Tivicay; Descovy
Intervention MeSH terms: Tenofovir; Emtricitabine; Dolutegravir; Emtricitabine tenofovir alafenamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment