NCT06766331

Brief Summary

Opioid use disorder (OUD) confers a higher risk of acquiring and transmitting infectious diseases, which may have long-term health consequences in Veterans. Treatment of OUD with medication assisted therapy is highly effective, however this often occurs independently of infectious diseases care. This project will test out a new model that combines infectious diseases and OUD care within one VA clinic appointment. This new care model may improve the health of Veterans and reduce cost and time required for Veterans who often need to attend multiple outpatient appointments.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Apr 2028

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
3.2 years until next milestone

Study Start

First participant enrolled

April 3, 2028

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2029

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

January 2, 2025

Last Update Submit

April 21, 2026

Conditions

HIVHepatitis C VirusGonorrheaChlamydiaSyphilisSexually Transmitted InfectionIntegrated CareMedications for Opioid Use DisorderOpioid Use Disorder

Keywords

Hepatitis CHIVsexually transmitted diseasesOpioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Infectious diseases screening uptake during intervention period

    Proportion of Veterans who completed any screening for HIV, hepatitis C virus (HCV), gonorrhea, chlamydia, or syphilis during the intervention period

    90 days

Secondary Outcomes (14)

  • PrEP uptake during intervention period

    90 days

  • HIV screening uptake during intervention period

    90 days

  • HCV screening uptake during intervention period

    90 days

  • Gonorrhea screening uptake during intervention period

    90 days

  • Chlamydia screening uptake during intervention period

    90 days

  • +9 more secondary outcomes

Other Outcomes (2)

  • Feasibility of the integrated care intervention

    90 days

  • Acceptability of the integrated care intervention

    90 days

Study Arms (2)

Integrated care

EXPERIMENTAL

Study visit 1: Participants will first complete a study interview, then will receive a prescription for laboratory testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), gonorrhea, chlamydia, and syphilis. Those who meet eligibility criteria for PrEP will receive a prescription for PrEP (emtricitabine 200 mg (FTC)/25 mg tenofovir alafenamide-emtricitabine (TAF) or once daily emtricitabine 200 mg (FTC)/300 mg tenofovir disoproxil fumarate-emtricitabine (TDF)), and will be referred to the Infectious Diseases clinic for PrEP follow-up. Participants will then complete a standard SUD clinic appointment. Study visit 2: Participants will follow-up at 90 days in the SUD clinic where they will repeat the study interview, followed by receipt of standard SUD clinical care.

Other: Integrated care

Treatment as usual

NO INTERVENTION

Study visit 1: Participants will first complete a study interview, then will complete a standard SUD clinic appointment. After the SUD appointment, participants will be referred to the Infectious Diseases clinic to receive standard infectious diseases laboratory testing, including HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), gonorrhea, chlamydia, and syphilis. Those who meet eligibility criteria for PrEP will receive a prescription for PrEP (emtricitabine 200 mg (FTC)/25 mg tenofovir alafenamide-emtricitabine (TAF) or once daily emtricitabine 200 mg (FTC)/300 mg tenofovir disoproxil fumarate-emtricitabine (TDF) through the infectious diseases clinic. Study visit 2: Participants will follow-up at 90 days in the SUD clinic where they will repeat the study interview, followed by receipt of their standard SUD clinical care.

Interventions

Integrated careOTHER

Receipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment.

Integrated care

Eligibility Criteria

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

You may qualify if:

  • US Veteran
  • Able to provide written informed consent in English
  • Living in the community (Nassau, Suffolk, Kings, Queens, Bronx, Westchester, Rockland counties, NY)
  • Documented diagnosis of moderate to severe opioid use disorder
  • Seeking care at the Northport VA substance use disorder clinic for opioid use disorder treatment
  • Willing to have HIV, HBV, HCV, or bacterial STI testing to determine negative or positive status
  • Persons who test negative for HIV need to meet CDC PrEP eligibility criteria in the 6 months prior to enrollment

You may not qualify if:

  • Severe medical or psychiatric disability making participation unsafe
  • Unable to provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northport VA Medical Center, Northport, NY

Northport, New York, 11768-2200, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersHepatitis CGonorrheaChlamydia InfectionsSyphilisSexually Transmitted Diseases

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialGenital DiseasesUrogenital DiseasesChlamydiaceae InfectionsTreponemal InfectionsSpirochaetales InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Audun J Lier, MD

    Northport VA Medical Center, Northport, NY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Audun J Lier, MD

CONTACT

(631) 261-4400audun.lier@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive either integrated care (infectious diseases screening and/or PrEP for HIV plus opioid use disorder clinical care within one clinic appointment) or treatment as usual (opioid use disorder clinical care plus infectious diseases clinic referral for testing and/or PrEP for HIV)
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 9, 2025

Study Start (Estimated)

April 3, 2028

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

June 29, 2029

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)