NCT03512964

Rapid HIV Treatment Initiation, Access and Engagement in Care

A Pilot Study of Rapid HIV Treatment Initiation, Access and Engagement in Care (RHAE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Dolutegravir 50 MG	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.
DRUG	Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [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 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.

Timeline

• Start date: 2016-11-29
• Primary completion: 2020-09-13
• Completion: 2020-09-13
• First posted: 2018-05-01
• Last updated: 2022-10-27
• Results posted: 2022-10-27

Locations

1 site across 1 country: United States