MAPS PrEP Van Study

Phase 4

Not yet recruiting

• Conditions: HIV Infection
• Interventions: Drug: Pre-Exposure Prophylaxis (PrEP)

• Registration Number: NCT06908252
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-26
• Study First Posted: 2025-04-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Start: 2025-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PrEP	Pre-Exposure Prophylaxis (PrEP)	All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Duke Department of Population Health Sciences; 🇺🇸 Durham, North Carolina, United States