Decision Support Tool to Integrate PrEP Into Emergency Departments

ConditionHIV

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorGeorge Washington University

About this trial

This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English-speaking

Self-report being HIV negative (GWU sites) or are found to be HIV rapid test negative (JHH ED)

Medically stable ED/UC patients (defined as a triage category level 3, 4, 5 using Emergency Severity Index for ED patients only)

Disqualifiers

Currently taking PEP, PrEP, or present with signs/symptoms of acute HIV infection

Pregnant

Currently taking a nephrotoxic medication

Diagnosed with medical conditions that are contraindicated with use of TDF/FTC or TAF/FTC

Trial design

Design model

Sequential

Treatments tested in this trial

Decision support tool
Behavioral
Participants enrolled during Phase 2 will engage in all the activities from Phase 1 and will receive the DST intervention. The DST will be designed and programmed to generate results if tablet-based (or to be easily manually scored if paper-based) to display the participant's PrEP knowledge and intention score, self-efficacy score, level of self-perceived risk, as well as generate a list of unmet needs. Upon completion of the DST, the Champion will review these results and discuss them with the participant. Referrals for needed resources will be proactively provided in the ED. After the DST delivery, participants will receive a PrEP prescription and follow-up appointment with a community PrEP provider.
PrEP Delivery
Behavioral
Participants enrolled during Phase 1 will receive a 14-day prescription of TDF/FTC or FTC/TAF before leaving the ED and an appointment with a community PrEP provider. The Champion will provide brief HIV prevention and PrEP medication counseling including proper dosing, missed doses, review of medication side effects and efficacy, and risk reduction counseling including condom use. Participants will receive a PrEP information brochure. The Champion will also make the initial appointment with the PrEP community provider for within 7 days of the ED visit. Community PrEP providers will be identified using local resources, CDC PrEP locators, and insurance; appointments will be scheduled according to patient preference. All participants will receive a text message reminder two days prior, and a reminder call one day prior.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: ED-PrEPActive comparator 1 intervention

Group B: ED-PrEP + DSTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Number of participants who self-report taking PrEP in the past 4 months and have any TFV-DP detected in DBS

PrEP persistence defined as self-report of taking PrEP in the past 4 months and having any TFV-DP detected in DBS

Time frame

4 months

Secondary outcomes

Number of participants who fill a PrEP prescription from the ED

PrEP initiation defined as the number of participants who fill a PrEP prescription from the ED confirmed via EMR

Time frame

1 week

Number of participants who attend a PrEP clinic visit

Initial PrEP linkage defined as the number of participants who attend a clinic visit confirmed via self-report or clinic record

Time frame

1 week

Number of participants who self-report PrEP adherence

PrEP adherence defined as the number of participants who report taking PrEP over the last 4-7 days in a 1-week period

Time frame

4 months

Number of participants with biological PrEP adherence (effective short-term use)

Presence of TFV on urine assay at 1 month

Time frame

1 month

Other outcomes

Proportion of eligible patients approached

Time frame

from baseline screening in the ED to being approached to be in the study in a 14 month period of time

Proportion of eligible patients tested for HIV

Time frame

from baseline ED screening to study eligibility in a 14 month period of time

Proportion of eligible patients prescribed PrEP

Time frame

from screening eligible to discharge from the ED in a 14 month period of time

Proportion who completed the DST intervention

Intervention group

Time frame

Through study completion at 4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Washington University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Johns Hopkins University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: