Pre-exposure Prophylaxis (PrEP) Rapid Access

Not Applicable

Completed

• Conditions: Opioid Use Disorder; Drug Use; Pre-exposure Prophylaxis (PrEP)

• Registration Number: NCT05528562
• Lead Sponsor: Boston Medical Center

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.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Study Start: 2023-04-12
• Primary Completion: 2023-06-28
• Study Completion: 2023-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants enrolled	12 months	Feasibility will be assessed by the number of participants enrolled
Acceptability of PrEP rapid Access	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants interested in initiating PrEP	Through study completion, an average of 1 year	This information will be obtained from information recorded on the day of recruitment from the survey data.
Number of participants who perform HIV self-test	Through study completion, an average of 1 year	This information will be obtained from information recorded on the day of recruitment for the study.

Trial Locations

Locations (1)

Victory Program; 🇺🇸 Boston, Massachusetts, United States