Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans

Integrating Infectious Diseases Screening and Treatment With Medication Assisted Therapy for Veterans With Opioid Use Disorder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Hepatitis C Virus; Opioid Use Disorder; Chlamydia; Gonorrhea; Syphilis; Integrated Care; Sexually Transmitted Infection; Medications for Opioid Use Disorder
• Intervention / Treatment: Other: Integrated care

Detailed Description

Opioid use disorder (OUD) is associated with increased risk for overdose as well as acquisition and transmission of infectious diseases (ID), including HIV, hepatitis C virus (HCV), and bacterial sexually transmitted infections (STI). Previous studies support improved clinical outcomes when integrating treatment for OUD and screening and treatment of HIV and HCV in non-Veteran populations. However, clinical care for Veterans with OUD often requires appointments with multiple different healthcare providers. These care silos place an increased burden on this patient population who often have barriers to appointment attendance. Improved integration OUD and ID clinical care is needed. In a recent study of Veterans with OUD who accessed care at the Northport VA (Long Island, NY) the investigators identified 216 (43%) Veterans who had a history of injecting drug use and of those, 134 (62%) had HCV and 30 (13.9%) had at least one severe injection related infection requiring hospitalization. The investigators also found low rates of screening for bacterial sexually transmitted infections, including syphilis (n=371, 74%), gonorrhea (n=160, 31.9%), chlamydia (n=169, 33.7%) and low uptake of HIV pre-exposure prophylaxis (PrEP) (n=4, 0.8%). In this pilot study, the investigators will assess the feasibility and acceptability of an integrated ID screening and PrEP intervention for Veterans with OUD who are engaged in care through the Northport VA SUD clinic. The investigators will randomize Veterans to receive either integrated care (HIV, HCV, STI screening and/or PrEP plus SUD care) or treatment as usual (SUD care plus ID clinic referral). The investigators will also compare rates of HIV, HCV and bacterial STI screening as well as PrEP uptake between the groups. This research will benefit male and female Veterans with OUD. This project will be carried out at the Northport Veterans Affairs Medical Center (NVAMC). Information obtained from this study will be utilized to inform a larger multi-site VA trial assessing the efficacy of IC versus usual care.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audun J Lier, MD; Phone Number: 4827 (631) 261-4400; Email: audun.lier@va.gov

Study Locations

• United States
  • New York
    • Northport, New York, United States, 11768-2200
      • Northport VA Medical Center, Northport, NY
      • Principal Investigator: Audun J Lier, MD
      • Contact: Audun J Lier, MD; Phone Number: 4827 631-261-4400; Email: audun.lier@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe medical or psychiatric disability making participation unsafe
• Unable to provide written consent
• PrEP exclusion: HIV positive test; HBV positive test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated care; 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; Receipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment.
No Intervention: Treatment as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP uptake during intervention period	Proportion who initiated PrEP for HIV during the intervention period	90 days
HIV screening uptake during intervention period	Proportion who completed screening for HIV during the intervention period	90 days
HCV screening uptake during intervention period	Proportion who completed screening for HCV during the intervention period	90 days
Gonorrhea screening uptake during intervention period	Proportion who completed screening for gonorrhea during the intervention period	90 days
Chlamydia screening uptake during intervention period	Proportion who completed screening for chlamydia during the intervention period	90 days
Syphilis screening uptake during intervention period	Proportion who completed screening for syphilis during the intervention period	90 days
PrEP uptake during follow-up period	Proportion who initiated PrEP for HIV at any point during the follow-up period	270 days
HIV screening uptake during follow-up period	Proportion who completed screening for HIV at any point during the follow-up period	270 days
HCV screening uptake during follow-up period	Proportion who completed screening for HCV at any point during the follow-up period	270 days
Gonorrhea screening uptake during follow-up period	Proportion who completed screening for gonorrhea at any point during the follow-up period	270 days
Chlamydia screening uptake during follow-up period	Proportion who completed screening for chlamydia at any point during the follow-up period	270 days
Syphilis screening uptake during follow-up period	Proportion who completed screening for syphilis at any point during the follow-up period	270 days
PrEP retention during the intervention period	Proportion of Veterans who adhered to the PrEP prescription during the intervention period	90 days
PrEP retention during the follow-up period	Proportion of Veterans who adhered to the PrEP prescription during the follow-up period	270 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the integrated care intervention	Proportion of Veterans who agreed that the integrated care intervention was a feasible care model for the substance use disorder clinic	90 days
Acceptability of the integrated care intervention	Proportion of Veterans who agreed that the integrated care intervention was an acceptable care model for the substance use disorder clinic	90 days

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Audun J Lier, MD, Northport VA Medical Center, Northport, NY

Study record dates

Study Major Dates

• Study Start (Estimated): April 3, 2028
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): June 29, 2029

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Hepatitis C; Opioid-Related Disorders; sexually transmitted diseases
• Additional Relevant MeSH Terms: Blood-Borne Infections; Narcotic-Related Disorders; Urogenital Diseases; Genital Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Flaviviridae Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Hepatitis; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Treponemal Infections; Pathological Conditions, Signs and Symptoms; Opioid-Related Disorders; Sexually Transmitted Diseases; Hepatitis C; Chlamydia Infections; Gonorrhea; Syphilis; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Patient Care Management; Delivery of Health Care, Integrated
• Other Study ID Numbers: INFA-010-24S; 1IK2CX002822-01A1 (U.S. NIH Grant/Contract: VAORD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No