Clinical trial NCT05528562: Pre-exposure Prophylaxis (PrEP) Rapid Access
Official title: PrEP Rapid Access: An Open Pilot Study- Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Pre-exposure Prophylaxis (PrEP)
Opioid Use Disorder
Keywords: People who inject drugs (PWID)
Rapid PrEP Access
Substance use
Mobile health van
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Victory Programs
First posted: 2022-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program.

Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. The study will be carried out at the Victory Program.

Aim 2: To determine the feasibility and acceptability of 'Rapid PrEP Access' at the Victory Program.

Detailed description: For phase 1 of the study, participants will be recruited for a one-time baseline interview and HIV self-testing. A questionnaire will also be administered to assess their interest in the HIV prevention pill (PrEP= pre-exposure prophylaxis), but PrEP will not be offered. Study duration for each participant is one day; participants will not be followed over time.

After the prescreener and consent forms are completed, the Research Assistant (RA) will offer the participant an opportunity to administer an HIV self-test. The participant will be provided the test for unboxing and retrieving the user instructions.

All testing will be performed and interpreted by participants. The RA can provide assistance with reading the instruction on how to obtain a proper sample. Alternatively, the RA will direct them to information in the package insert which includes support offered by the OraQuick® Support Center.

After completing the HIVST, the RA will complete the baseline questionnaire with each participant while waiting for the participants' HIVST results. After the baseline questionnaire is complete, the RA will conduct satisfaction surveys to assess acceptability of the intervention and interest of PrEP initiation using REDCap.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Opioid use that was not prescribed by a health professional in the past 6 months

Exclusion Criteria:

* Pregnant women
* Persons with previous HIV diagnosis
* Individuals currently taking PrEP
* Individuals who express desire to harm themselves or others

Primary outcomes:
measure: Number of participants enrolled
timeFrame: 12 months
measure: Acceptability of PrEP rapid Access
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants who perform HIV self-test
timeFrame: Through study completion, an average of 1 year
measure: Number of participants interested in initiating PrEP
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Victory Program
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Infectious Diseases
name: Sabrina Assoumou, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: