N/A
N=32
Rapid HIV Treatment Initiation, Access and Engagement in Care
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT03512964 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Oct 2022
Primary outcome: Primary: Number of Patients Who Receive Rapid HIV Treatment Initiation — 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dolutegravir 50 MG (Drug); Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Receive Rapid HIV Treatment Initiation |
32 | — |
| SECONDARY Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day |
32 | — |
| SECONDARY Number of Patients Offered Rapid HIV Treatment Initiation |
32 | — |
| SECONDARY Number of Patients Who Accepted Rapid HIV Treatment Initiation |
32 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03512964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.