Pre-exposure Prophylaxis (PrEP) Rapid Access

Opioid Use Disorder Clinical Trial

Official title:

PrEP Rapid Access: An Open Pilot Study- Phase 1

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05528562
• Other study ID #: H-43090
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• PrEP Rapid Access
'Rapid PrEP Access' is a low-threshold intervention designed to provide on-site access to HIV self-testing at the Victory Program for persons who use opioids.
• HIV self-testing
After enrollment the research assistant (RA) will provide the participant with a HIV self-test and provide instructions on how to obtain a proper sample for the test. It uses an oral fluid test and yields results within 20 minutes.
• Dried blood spot testing
HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load.

Locations

Country	Name	City	State
United States	Victory Program	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Victory Programs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants enrolled	Feasibility will be assessed by the number of participants enrolled	12 months
Primary	Acceptability of PrEP rapid Access	Participants will rate PrEP Rapid Access' acceptability using an investigator-developed scale ranging from 1 to 5 where 1= not acceptable and 5 is very acceptable.	Through study completion, an average of 1 year
Secondary	Number of participants who perform HIV self-test	This information will be obtained from information recorded on the day of recruitment for the study.	Through study completion, an average of 1 year
Secondary	Number of participants interested in initiating PrEP	This information will be obtained from information recorded on the day of recruitment from the survey data.	Through study completion, an average of 1 year