MAPS PrEP Van Study (MAPS PrEP)

January 16, 2026 updated by: Duke University

Integrating PrEP Into Mobile Addiction Treatment and Primary Care Services

For this study the investigators aim to see if giving participants an oral HIV prevention medication on a medical van, is a good option of care for individuals who inject drugs and/or are sexually active and therefore at a higher risk of contracting HIV.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate a pilot program that provides Pre-Exposure Prophylaxis (PrEP) for people who use drugs (PWUD) and are at risk for contracting HIV. Given the ongoing overdose crisis and the risk of HIV among PWUD, this study aims to assess weather offering oral PrEP on a Medical Mobile Unit (MMU) is a viable strategy for preventing HIV transmission in high-risk populations. The other goal of this study is to assess community perceptions of PrEP and perceived HIV risk among Syringe Service Program (SSP) clients visiting a MMU.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Recruiting
        • Duke Department of Population Health Sciences
        • Contact:
        • Principal Investigator:
          • Jaqueline Hodges, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older, active drug injection user and/or sexually active, referred from the Syringe Service Program

Exclusion Criteria:

  • positive HIV status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrEP
All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV.
Drug: Pre-Exposure Prophylaxis (PrEP)
Oral Pre-Exposure Prophylaxis (PrEP) pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment
Time Frame: Baseline
Number of participants utilizing medical mobile unit during study duration who are eligible for PrEP
Baseline
Negative HIV Status
Time Frame: up to 3 months
Number of participants who remain HIV negative at 3 months (Measured via negative HIV test at 3 months
up to 3 months
PrEP Consultation
Time Frame: up to 6 months
Number of participants who agree to PrEP consultation
up to 6 months
PrEP Initiation
Time Frame: up to 6 months
Number of participants who complete PrEP consultation and start PrEP
up to 6 months
Retention
Time Frame: up to 6 months
Number of participants who come back for 3 month and 6 month visit
up to 6 months
Follow Through
Time Frame: up to 6 months
Number of participants who pick up PrEP medication
up to 6 months
Negative HIV Status at 6 months
Time Frame: up to 6 months
Number of participants who remain HIV negative at 6 months (Measured via negative HIV test at 6 months)
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Mehri McKellar, MD, Duke Health
  • Principal Investigator: Jacqueline Hodges, MD, MPH, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00116108
  • 5P30AI064518-20 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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