NCT06766331

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Integrated care	Receipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment.

Timeline

• Start date: 2028-04-03
• Primary completion: 2029-03-30
• Completion: 2029-06-29
• First posted: 2025-01-09
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States