NCT05528562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

September 1, 2022

Last Update Submit

July 15, 2024

Conditions

Drug UsePre-exposure Prophylaxis (PrEP)Opioid Use Disorder

Keywords

People who inject drugs (PWID)Rapid PrEP AccessSubstance useMobile health van

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Number of participants who perform HIV self-test

    Through study completion, an average of 1 year

  • Number of participants interested in initiating PrEP

    Through study completion, an average of 1 year

Study Arms (1)

PrEP Rapid Access

EXPERIMENTAL

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

Other: PrEP Rapid AccessOther: HIV self-testingOther: Dried blood spot testing

Interventions

PrEP Rapid AccessOTHER

'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.

PrEP Rapid Access
HIV self-testingOTHER

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.

PrEP Rapid Access
Dried blood spot testingOTHER

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

PrEP Rapid Access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Opioid use that was not prescribed by a health professional in the past 6 months

You may not qualify if:

  • Pregnant women
  • Persons with previous HIV diagnosis
  • Individuals currently taking PrEP
  • Individuals who express desire to harm themselves or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victory Program

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Assoumou SA, Bonilla HV, Ruiz-Mercado G, Von Lossnitzer M, Baker R, Crawford ND, Bernstein JA. Community-based HIV Self-testing for Persons Who Use Drugs Can Contribute to Reaching Ending the HIV Epidemic in the US (EHE) Goals. Open Forum Infect Dis. 2024 Jun 17;11(6):ofae189. doi: 10.1093/ofid/ofae189. eCollection 2024 Jun.

    PMID: 38887480DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Dried Blood Spot Testing

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sabrina Assoumou, MD MPH

    Boston Medical Center, Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

April 12, 2023

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)