Skip to main content
OpenTrials
Completed

NCT Number: NCT05528562

Pre-exposure Prophylaxis (PrEP) Rapid Access

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Pre-Exposure Prophylaxis (PrEP) Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victory Program

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrEP Rapid Access

Other

'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.

HIV self-testing

Other

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.

Dried blood spot testing

Other

HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load.

Primary outcomes

  1. Number of participants enrolled

    Time frame: 12 months

    Feasibility will be assessed by the number of participants enrolled

  2. Acceptability of PrEP rapid Access

    Time frame: 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 outcomes

  1. Number of participants who perform HIV self-test

    Time frame: Through study completion, an average of 1 year

    This information will be obtained from information recorded on the day of recruitment for the study.

  2. Number of participants interested in initiating PrEP

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Victory Programs

Registry information

Official study title

PrEP Rapid Access: An Open Pilot Study- Phase 1

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.