Pre-Exposure Prophylaxis in the Emergency Department

Status Completed

Clinical Trial Summary

Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be realized. Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been identified, including: 1) patient and provider lack of knowledge, 2) lack of access to medical care among high-risk individuals, 3) provider discomfort and inexperience with screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to expand access to and engagement in PrEP among high risk individuals though an innovative delivery approach in the Emergency Department (ED) while addressing these four barriers.

Clinical Trial Description

Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and acceptability. 1. Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool. 2. During a 3-month period, use continuous quality improvement methods to decrease the time for completion of PrEP eligibility screening to an interval that is acceptable to ED patients and providers. Aim 2: Pre-Exposure Prophylaxis Provision in the ED (PrEPPED) Trial: Identify 40 PrEP eligible patients over a 12-month period who are interested in initiating PrEP in the ED. These patients will be offered immediate PrEP (iPrEP) initiation in the ED with facilitated linkage to comprehensive out-patient care. 1. Evaluate the impact of a PrEP "starter pack" on patients agreeing to iPrEP. The primary outcome is engagement in care at 30-days post PrEP initiation visit. Secondary outcomes include retention in care, STI diagnosis, risk behavior and PrEP adherence. 2. Collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive trial of ED-initiated PrEP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04429971
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Completed
Phase	N/A
Start date	March 18, 2020
Completion date	July 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03215901` - Life Plans Intervention Study	N/A
Completed	`NCT03289676` - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV	Phase 1
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting	`NCT04064567` - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK	N/A
Completed	`NCT04013295` - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya	N/A
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT03984136` - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM	N/A
Completed	`NCT02928900` - Patient Actor Training to Improve HIV Services for Adolescents in Kenya	N/A
Recruiting	`NCT03268109` - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed	`NCT02797262` - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System	N/A
Completed	`NCT02376582` - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS	Phase 1
Completed	`NCT01957865` - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda	N/A
Terminated	`NCT01443923` - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV	Phase 4
Completed	`NCT01616940` - Minority AIDS Initiative Retention and Re-Engagement Project	N/A
Completed	`NCT01910714` - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth	N/A
Completed	`NCT01084421` - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos	N/A
Completed	`NCT01596322` - International HIV Antiretroviral Adherence, Resistance and Survival	N/A
Completed	`NCT03643705` - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention	N/A
Completed	`NCT03923231` - Pharmacokinetics of Atazanavir in Special Populations

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pre-Exposure Prophylaxis in the Emergency Department — PrEPPED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms