Rapid HIV Treatment Initiation, Access and Engagement in Care

NCT03512964 | Completed Results

• 2 other identifiers: IRB00110075P30AI094189
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• 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 Offered Rapid HIV Treatment Initiation

  12 months

• Number of Patients Who Accepted Rapid HIV Treatment Initiation

  12 months

Study Arms (1)

Rapid HIV Treatment Initiation

OTHER

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]

Interventions

Dolutegravir 50 MG DRUG

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

Rapid HIV Treatment Initiation

Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY] DRUG

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

Rapid HIV Treatment Initiation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravir; Emtricitabine; tenofovir alafenamide; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Joyce Jones, MD
• Organization: Johns Hopkins University School of Medicine, Division of Infectious Diseases

jjone154@jhmi.edu

443-287-8530

Study Officials

• Joyce Jones, MD

  JohnsHopkins U

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: November 29, 2016
• Primary Completion: September 13, 2020
• Study Completion: September 13, 2020
• Last Updated: October 27, 2022
• Results First Posted: October 27, 2022

Record last verified: 2022-09

Locations

US (1)