Pre-exposure Prophylaxis (PrEP) Rapid Access
PrEP Rapid Access: An Open Pilot Study- Phase 1
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Victory Program
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: PrEP Rapid Access
Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van.
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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.
HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load.
'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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of participants enrolled
Time Frame: 12 months
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Feasibility will be assessed by the number of participants enrolled
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12 months
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Acceptability of PrEP rapid Access
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of participants who perform HIV self-test
Time Frame: Through study completion, an average of 1 year
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This information will be obtained from information recorded on the day of recruitment for the study.
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Through study completion, an average of 1 year
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Number of participants interested in initiating PrEP
Time Frame: Through study completion, an average of 1 year
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This information will be obtained from information recorded on the day of recruitment from the survey data.
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Through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sabrina Assoumou, MD MPH, Boston Medical Center, Infectious Diseases
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-43090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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