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Completed

NCT Number: NCT06908252

MAPS PrEP Van Study

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke Department of Population Health Sciences

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Pre-Exposure Prophylaxis (PrEP)

Drug

Oral Pre-Exposure Prophylaxis (PrEP) pills

Primary outcomes

  1. Enrollment

    Time frame: Baseline

    Number of participants utilizing medical mobile unit during study duration who are eligible for PrEP

  2. 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

  3. PrEP Consultation

    Time frame: up to 6 months

    Number of participants who agree to PrEP consultation

  4. PrEP Initiation

    Time frame: up to 6 months

    Number of participants who complete PrEP consultation and start PrEP

  5. Retention

    Time frame: up to 6 months

    Number of participants who come back for 3 month and 6 month visit

  6. Follow Through

    Time frame: up to 6 months

    Number of participants who pick up PrEP medication

  7. 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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: MAPS PrEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Jul 24, 2026

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.

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