Human Immunodeficiency Virus
Conditions
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.
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.
Interventions
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.
DRUGEmtricitabine/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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive Rapid HIV Treatment Initiation | 12 months | Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day | 12 months | Number of patients who respond yes to starting ART same day versus those who respond no in the survey. |
| Number of Patients Offered Rapid HIV Treatment Initiation | 12 months | — |
| Number of Patients Who Accepted Rapid HIV Treatment Initiation | 12 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Rapid HIV Treatment Initiation |
|---|---|
| Age, Continuous | 40 years |
| Race/Ethnicity, Customized Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 30 Participants |
| Race/Ethnicity, Customized Don't know | 0 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Other Asian | 0 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Refused | 0 Participants |
| Race/Ethnicity, Customized Some other race | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 32 |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 1 / 32 |
Outcome results
Primary
Number of Patients Who Receive Rapid HIV Treatment Initiation
Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid HIV Treatment Initiation | Number of Patients Who Receive Rapid HIV Treatment Initiation | 32 Participants |
Secondary
Number of Patients Offered Rapid HIV Treatment Initiation
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid HIV Treatment Initiation | Number of Patients Offered Rapid HIV Treatment Initiation | 32 Participants |
Secondary
Number of Patients Who Accepted Rapid HIV Treatment Initiation
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid HIV Treatment Initiation | Number of Patients Who Accepted Rapid HIV Treatment Initiation | 32 Participants |
Secondary
Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day
Number of patients who respond yes to starting ART same day versus those who respond no in the survey.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid HIV Treatment Initiation | Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day | 32 Participants |