Clinical trial NCT06766331: Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
Official title: Integrating Infectious Diseases Screening and Treatment With Medication Assisted Therapy for Veterans With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
HIV
Hepatitis C Virus
Gonorrhea
Chlamydia
Syphilis
Sexually Transmitted Infection
Integrated Care
Medications for Opioid Use Disorder
Keywords: Hepatitis C
HIV
sexually transmitted diseases
Opioid-Related Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Infectious diseases screening uptake during intervention period
timeFrame: 90 days
Secondary outcomes:
measure: PrEP uptake during intervention period
timeFrame: 90 days
measure: HIV screening uptake during intervention period
timeFrame: 90 days
measure: HCV screening uptake during intervention period
timeFrame: 90 days
measure: Gonorrhea screening uptake during intervention period
timeFrame: 90 days
measure: Chlamydia screening uptake during intervention period
timeFrame: 90 days
measure: Syphilis screening uptake during intervention period
timeFrame: 90 days
measure: PrEP uptake during follow-up period
timeFrame: 270 days
measure: HIV screening uptake during follow-up period
timeFrame: 270 days
measure: HCV screening uptake during follow-up period
timeFrame: 270 days
measure: Gonorrhea screening uptake during follow-up period
timeFrame: 270 days
measure: Chlamydia screening uptake during follow-up period
timeFrame: 270 days
measure: Syphilis screening uptake during follow-up period
timeFrame: 270 days
measure: PrEP retention during the intervention period
timeFrame: 90 days
measure: PrEP retention during the follow-up period
timeFrame: 270 days
Other outcomes:
measure: Feasibility of the integrated care intervention
timeFrame: 90 days
measure: Acceptability of the integrated care intervention
timeFrame: 90 days
Locations:
city: Northport
country: United States
facility: Northport VA Medical Center, Northport, NY
state: New York
Study officials:
affiliation: Northport VA Medical Center, Northport, NY
name: Audun J Lier, MD
role: PRINCIPAL_INVESTIGATOR
References: