Drug Use, Opioid Use Disorder, Pre-exposure Prophylaxis (PrEP)
Conditions
Keywords
People who inject drugs (PWID), Rapid PrEP Access, Substance use, Mobile health van
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.
Interventions
OTHERPrEP Rapid Access
'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.
OTHERHIV self-testing
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.
Sponsors
Victory Programs
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed