MedPath

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.

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
NameTimeMethod
Number of participants enrolled12 months

Feasibility will be assessed by the number of participants enrolled

Acceptability of PrEP rapid AccessThrough 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
NameTimeMethod
Number of participants interested in initiating PrEPThrough 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-testThrough 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

Victory Program
🇺🇸Boston, Massachusetts, United States

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