Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrated care.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, HIV, Hepatitis C Virus, Gonorrhea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrating Infectious Diseases Screening and Treatment With Medication Assisted Therapy for Veterans With Opioid Use Disorder
Overview
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.
Interventions
- Other Integrated care
Receipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment.
Primary outcome measures
- Infectious diseases screening uptake during intervention period [Time frame: 90 days]
Secondary outcome measures (12)
- PrEP uptake during intervention period [Time frame: 90 days]
- HIV screening uptake during intervention period [Time frame: 90 days]
- HCV screening uptake during intervention period [Time frame: 90 days]
- Gonorrhea screening uptake during intervention period [Time frame: 90 days]
- Chlamydia screening uptake during intervention period [Time frame: 90 days]
- Syphilis screening uptake during intervention period [Time frame: 90 days]
- PrEP uptake during follow-up period [Time frame: 270 days]
- HIV screening uptake during follow-up period [Time frame: 270 days]
- HCV screening uptake during follow-up period [Time frame: 270 days]
- Gonorrhea screening uptake during follow-up period [Time frame: 270 days]
- Chlamydia screening uptake during follow-up period [Time frame: 270 days]
- Syphilis screening uptake during follow-up period [Time frame: 270 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Northport VA Medical Center, Northport, NY — Northport
Identifiers
NCT: NCT06766331 · INFA-010-24S · 1IK2CX002822-01A1