Rapid HIV Treatment Initiation, Access and Engagement in Care

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.

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