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Pre-exposure Prophylaxis (PrEP) Rapid Access

Primary Purpose

Drug Use, Pre-exposure Prophylaxis (PrEP), Opioid Use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrEP Rapid Access
HIV self-testing
Dried blood spot testing
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Drug Use focused on measuring People who inject drugs (PWID), Rapid PrEP Access, Substance use, Mobile health van

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking
  • Injected at least one non-prescribed drug in the past 90 days
  • Willingness to sign a medical records release form for access to PrEP-related follow-up studies performed in other clinical settings.

Exclusion Criteria:

  • Pregnant women
  • Individuals living with HIV
  • Individuals currently engaged with PrEP (having at least 2 medical visits for PrEP in 6 months)
  • Individuals who not plan to live in the Boston area over the next 6 months
  • Individuals who express desire to harm themselves or others

Sites / Locations

  • Victory Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PrEP Rapid Access

Arm Description

Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van.

Outcomes

Primary Outcome Measures

Number of participants enrolled
Feasibility will be assessed by the number of participants enrolled
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.

Secondary Outcome Measures

Number of participants who perform HIV self-test
This information will be obtained from information recorded on the day of recruitment for the study.
Number of participants interested in initiating PrEP
This information will be obtained from information recorded on the day of recruitment from the survey data.

Full Information

First Posted
September 1, 2022
Last Updated
July 5, 2023
Sponsor
Boston Medical Center
Collaborators
Victory Programs
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1. Study Identification

Unique Protocol Identification Number
NCT05528562
Brief Title
Pre-exposure Prophylaxis (PrEP) Rapid Access
Official Title
PrEP Rapid Access: An Open Pilot Study- Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Victory Programs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Pre-exposure Prophylaxis (PrEP), Opioid Use Disorder
Keywords
People who inject drugs (PWID), Rapid PrEP Access, Substance use, Mobile health van

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PrEP Rapid Access
Arm Type
Experimental
Arm Description
Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van.
Intervention Type
Other
Intervention Name(s)
PrEP Rapid Access
Intervention Description
'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.
Intervention Type
Other
Intervention Name(s)
HIV self-testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dried blood spot testing
Intervention Description
HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load.
Primary Outcome Measure Information:
Title
Number of participants enrolled
Description
Feasibility will be assessed by the number of participants enrolled
Time Frame
12 months
Title
Acceptability of PrEP rapid Access
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Number of participants who perform HIV self-test
Description
This information will be obtained from information recorded on the day of recruitment for the study.
Time Frame
Through study completion, an average of 1 year
Title
Number of participants interested in initiating PrEP
Description
This information will be obtained from information recorded on the day of recruitment from the survey data.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina Assoumou, MD MPH
Organizational Affiliation
Boston Medical Center, Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victory Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pre-exposure Prophylaxis (PrEP) Rapid Access

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