HIV InfectionPhase 4MAPS PrEPNCT06908252
MAPS PrEP Van Study
A Phase 4 study testing Pre-Exposure Prophylaxis (PrEP) in people with HIV Infection, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Pre-Exposure Prophylaxis (PrEP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to 13 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, active drug injection user and/or sexually active, referred from the Syringe Service Program
Who cannot join
- positive HIV status
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Department of Population Health Sciences
Durham, North Carolina, 27701
About this study
Official title: Integrating PrEP Into Mobile Addiction and Primary Care Services (MAPS)
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- Pre-Exposure Prophylaxis (PrEP)
- Keywords
- People who inject drugs, Mobile Medical Unit, PrEP, Syringe Service Program, HIV prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Exposure Prophylaxis (PrEP)Drug
Oral Pre-Exposure Prophylaxis (PrEP) pills
| Study group | Role | What they receive |
|---|---|---|
| PrEP | Experimental | All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV. Receives: Drug: Pre-Exposure Prophylaxis (PrEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Number of participants utilizing medical mobile unit during study duration who are eligible for PrEP
Measured: Baseline
Negative HIV Status
Number of participants who remain HIV negative at 3 months (Measured via negative HIV test at 3 months
Measured: up to 3 months
PrEP Consultation
Number of participants who agree to PrEP consultation
Measured: up to 6 months
PrEP Initiation
Number of participants who complete PrEP consultation and start PrEP
Measured: up to 6 months
Retention
Number of participants who come back for 3 month and 6 month visit
Measured: up to 6 months
Follow Through
Number of participants who pick up PrEP medication
Measured: up to 6 months
Negative HIV Status at 6 months
Number of participants who remain HIV negative at 6 months (Measured via negative HIV test at 6 months)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start17 Sep 2025
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehri McKellar, MD, Principal investigator, Duke HealthJacqueline Hodges, MD, MPH, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908252
- Sponsor's protocol ID
- Pro00116108
- Other IDs
- 5P30AI064518-20
- Acronym
- MAPS PrEP
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating PrEP Into Mobile Addiction and Primary Care Services (MAPS)
- ClinicalTrials.gov ID
- NCT06908252
- Acronym / sponsor ID
- MAPS PrEP / Pro00116108
- Conditions
- HIV Infection
- Keywords
- People who inject drugs, Mobile Medical Unit, PrEP, Syringe Service Program, HIV prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP | Experimental | Drug: Pre-Exposure Prophylaxis (PrEP)All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, active drug injection user and/or sexually active, referred from the Syringe Service Program
Key exclusion criteria (1 listed)
- positive HIV status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Exposure Prophylaxis (PrEP)Oral Pre-Exposure Prophylaxis (PrEP) pills | Drug | PrEP |
Primary outcome
Enrollment
Time frame: Baseline
Number of participants utilizing medical mobile unit during study duration who are eligible for PrEP
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
PrEP Consultation
Time frame: up to 6 months
Number of participants who agree to PrEP consultation
PrEP Initiation
Time frame: up to 6 months
Number of participants who complete PrEP consultation and start PrEP
Retention
Time frame: up to 6 months
Number of participants who come back for 3 month and 6 month visit
Follow Through
Time frame: up to 6 months
Number of participants who pick up PrEP medication
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehri McKellar, MD principal investigator
Duke Health
Jacqueline Hodges, MD, MPH principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pre-Exposure Prophylaxis (PrEP) in people with HIV Infection, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.