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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06766331
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2028-04-03
• Primary Completion: 2029-03-30
• Study Completion: 2029-06-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infectious diseases screening uptake during intervention period	90 days	Proportion of Veterans who completed any screening for HIV, hepatitis C virus (HCV), gonorrhea, chlamydia, or syphilis during the intervention period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Northport VA Medical Center, Northport, NY; 🇺🇸 Northport, New York, United States