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

NCT ID: NCT06766331

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-04-03
• Study Completion Date: 2029-06-29

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.

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.

Conditions

Opioid Use Disorder; HIV; Hepatitis C Virus; Gonorrhea; Chlamydia; Syphilis; Sexually Transmitted Infection; Integrated Care; Medications for Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Integrated care

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audun J Lier, MD

Role: PRINCIPAL_INVESTIGATOR

Northport VA Medical Center, Northport, NY

Locations

Northport VA Medical Center, Northport, NY

Northport, New York, United States

Countries

United States

Central Contacts

Audun J Lier, MD

Role: CONTACT

audun.lier@va.gov

(631) 261-4400 ext. 4827

Facility Contacts

Fern Silverman

Role: primary

Fern.Silverman@va.gov

(631) 261-4400 ext. 7755

Joanne Toner

Role: backup

Joanne.Toner@va.gov

(631) 261-4400 ext. 2883

Other Identifiers

1IK2CX002822-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

INFA-010-24S

Identifier Type: -

Identifier Source: org_study_id