Pre-exposure Prophylaxis (PrEP) Rapid Access

Study Overview
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Brief Summary
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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
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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.

Official Title
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PrEP Rapid Access: An Open Pilot Study- Phase 1

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

Intervention / Treatment
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* Other: PrEP Rapid Access
* Other: HIV self-testing
* Other: Dried blood spot testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP Rapid Access<br>Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van. | Other: PrEP Rapid Access<br>* '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.<br>Other: HIV self-testing<br>* 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.<br>Other: Dried blood spot testing<br>* HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants enrolled | Feasibility will be assessed by the number of participants enrolled | 12 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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People who inject drugs (PWID), Rapid PrEP Access, Substance use, Mobile health van