An interventional study of Dolutegravir 50 MG and Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY] in Human Immunodeficiency Virus, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 32 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
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 50 MG · 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 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.
Also known as: Tivicay
Drug page: Emtricitabine tenofovir alafenamide
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.
Also known as: Descovy
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
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
Number of Patients Offered Rapid HIV Treatment Initiation
Time frame: 12 months
Number of Patients Who Accepted Rapid HIV Treatment Initiation
Time frame: 12 months
| Milestone | Rapid HIV Treatment Initiation |
|---|---|
| Started | 32 |
| Completed | 32 |
| Not completed | 0 |
Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered.
| Participants | Rapid HIV Treatment Initiation |
|---|---|
| Number of Patients Who Receive Rapid HIV Treatment Initiation | 32 |
Number of patients who respond yes to starting ART same day versus those who respond no in the survey.
| 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 | Rapid HIV Treatment Initiation |
|---|---|
| Number of Patients Offered Rapid HIV Treatment Initiation | 32 |
| Participants | Rapid HIV Treatment Initiation |
|---|---|
| Number of Patients Who Accepted Rapid HIV Treatment Initiation | 32 |
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rapid HIV Treatment Initiation | 1/32 (3.1%) | 1/32 (3.1%) | 1/32 (3.1%) |
| Event | Rapid HIV Treatment Initiation |
|---|---|
| DeathCardiac disorders | 1/32 |
| Event | Rapid HIV Treatment Initiation |
|---|---|
| Unnecessary ART initiationProduct Issues | 1/32 |
| Age, Continuous(years) | Rapid HIV Treatment Initiation |
|---|---|
| Mean | 40 (19 to 63) |
| Sex: Female, Male(Participants) | Rapid HIV Treatment Initiation |
|---|---|
| Female | 9 |
| Male | 23 |
| Race/Ethnicity, Customized(Participants) | Rapid HIV Treatment Initiation |
|---|---|
| White | 1 |
| Black/African American | 30 |
| Native American | 1 |
| Alaskan Native | 0 |
| Pacific Islander | 0 |
| Other Asian | 0 |
| Some other race | 0 |
| Refused | 0 |
| Don't know | 0 |
| Region of Enrollment(Participants) | Rapid HIV Treatment Initiation |
|---|---|
| United States | 32 |
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Ran from Nov 2016 to primary completion in Sep 2020, 45 months.
Results were first posted in Oct 2022, 2 years 1 month after primary completion. A results delay was requested in Sep 2021.
Of 497 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's 45 months is above that.
Counting every sponsor, half of 500 studies reached it within 31 months; a quarter within 18 and three quarters within 47.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dolutegravir · Emtricitabine tenofovir alafenamide
Acquired Immunodeficiency Syndrome →