NCT06908252

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
3mo left

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

March 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

March 20, 2025

Last Update Submit

January 16, 2026

Conditions

HIV Infection

Keywords

People who inject drugsMobile Medical UnitPrEPSyringe Service ProgramHIV prevention

Outcome Measures

Primary Outcomes (7)

  • Enrollment

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

    Baseline

  • Negative HIV Status

    Number of participants who remain HIV negative at 3 months (Measured via negative HIV test at 3 months

    up to 3 months

  • PrEP Consultation

    Number of participants who agree to PrEP consultation

    up to 6 months

  • PrEP Initiation

    Number of participants who complete PrEP consultation and start PrEP

    up to 6 months

  • Retention

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

    up to 6 months

  • Follow Through

    Number of participants who pick up PrEP medication

    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)

    up to 6 months

Study Arms (1)

PrEP

EXPERIMENTAL

All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV.

Drug: Pre-Exposure Prophylaxis (PrEP)

Interventions

Pre-Exposure Prophylaxis (PrEP)DRUG

Oral Pre-Exposure Prophylaxis (PrEP) pills

PrEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • positive HIV status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Department of Population Health Sciences

Durham, North Carolina, 27701, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Pre-Exposure Prophylaxis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Primary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Mehri McKellar, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

  • Jacqueline Hodges, MD, MPH

    Duke Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia R Ashkin-Baker, BA

CONTACT

(919)448-8680amelia.ashkin-baker@duke.edu

Madelene Travis, BA

CONTACT

madelene.travis@duke.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2025

First Posted

April 3, 2025

Study Start

September 17, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)