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

Part of paid clinical trials in Northport, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT06766331
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 3, 2028
Status verified
Apr 2026
Primary completion
Mar 30, 2029
Completion
Jun 29, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Infectious diseases screening uptake during intervention period [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northport VA Medical Center, Northport, NYNorthportNew York11768-2200
Audun J Lier, MD
[email protected]
631-261-4400
Audun J Lier, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Northport, NY

By condition
HIV
By specialty
Infectious disease
By research site
Northport VA Medical Center, Northport, NY· Northport, NY

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