MAPS PrEP Van Study

Integrating PrEP Into Mobile Addiction and Primary Care Services (MAPS)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06908252

Acronym

MAPS PrEP

Enrollment

Registered

2025-04-03

Start date

2025-09-17

Completion date

2026-05-13

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

People who inject drugs, Mobile Medical Unit, PrEP, Syringe Service Program, HIV prevention

Brief summary

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.

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.

Interventions

DRUGPre-Exposure Prophylaxis (PrEP)

Oral Pre-Exposure Prophylaxis (PrEP) pills

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMehri McKellar, MD

Duke Health

PRINCIPAL_INVESTIGATORJacqueline Hodges, MD, MPH