Pre-exposure Prophylaxis (PrEP) Rapid Access

Boston Medical Center (BMC)

Status: Completed

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

Treatments: Other: Dried blood spot testing; Other: PrEP Rapid Access; Other: HIV self-testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05528562

H-43090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PrEP Rapid Access

Experimental group

Description:

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

Treatment:

Other: HIV self-testing

Other: PrEP Rapid Access

Other: Dried blood spot testing