Opioid Use DisorderNCT06766331
Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
A study testing Integrated care in people with Opioid Use Disorder and HIV, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, HIV, Hepatitis C Virus
- What is being tested?
- Integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2028to 29 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide written consent
- PrEP exclusion: HIV positive test; HBV positive test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northport VA Medical Center, Northport, NY
Northport, New York, 11768-2200
Audun J Lier, MD, 631-261-4400 ext. 4827, audun.lier@va.gov
Audun J Lier, MD
About this study
Official title: Integrating Infectious Diseases Screening and Treatment With Medication Assisted Therapy for Veterans With Opioid Use Disorder
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.
Read the 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
- Being tested
- Integrated care
- Keywords
- Hepatitis C, HIV, sexually transmitted diseases, Opioid-Related Disorders
- Medical subject headings
- Opioid-Related Disorders, Hepatitis C, Gonorrhea, Chlamydia Infections, Syphilis, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated careOther
Receipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment.
| Study group | Role | What they receive |
|---|---|---|
| Integrated care | Experimental | 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. Receives: Other: Integrated care |
| Treatment as usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious diseases screening uptake during intervention period
Proportion of Veterans who completed any screening for HIV, hepatitis C virus (HCV), gonorrhea, chlamydia, or syphilis during the intervention period
Measured: 90 days
Secondary outcomes (14)
PrEP uptake during intervention period
Proportion who initiated PrEP for HIV during the intervention period
Measured: 90 days
HIV screening uptake during intervention period
Proportion who completed screening for HIV during the intervention period
Measured: 90 days
HCV screening uptake during intervention period
Proportion who completed screening for HCV during the intervention period
Measured: 90 days
Gonorrhea screening uptake during intervention period
Proportion who completed screening for gonorrhea during the intervention period
Measured: 90 days
Chlamydia screening uptake during intervention period
Proportion who completed screening for chlamydia during the intervention period
Measured: 90 days
Syphilis screening uptake during intervention period
Proportion who completed screening for syphilis during the intervention period
Measured: 90 days
PrEP uptake during follow-up period
Proportion who initiated PrEP for HIV at any point during the follow-up period
Measured: 270 days
HIV screening uptake during follow-up period
Proportion who completed screening for HIV at any point during the follow-up period
Measured: 270 days
HCV screening uptake during follow-up period
Proportion who completed screening for HCV at any point during the follow-up period
Measured: 270 days
Gonorrhea screening uptake during follow-up period
Proportion who completed screening for gonorrhea at any point during the follow-up period
Measured: 270 days
Chlamydia screening uptake during follow-up period
Proportion who completed screening for chlamydia at any point during the follow-up period
Measured: 270 days
Syphilis screening uptake during follow-up period
Proportion who completed screening for syphilis at any point during the follow-up period
Measured: 270 days
PrEP retention during the intervention period
Proportion of Veterans who adhered to the PrEP prescription during the intervention period
Measured: 90 days
PrEP retention during the follow-up period
Proportion of Veterans who adhered to the PrEP prescription during the follow-up period
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start3 Apr 2028 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Audun J Lier, MD, Principal investigator, Northport VA Medical Center, Northport, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766331
- Sponsor's protocol ID
- INFA-010-24S
- Other IDs
- 1IK2CX002822-01A1
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Infectious Diseases Screening and Treatment With Medication Assisted Therapy for Veterans With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06766331
- Acronym / sponsor ID
- INFA-010-24S
- Conditions
- Opioid Use Disorder, HIV, Hepatitis C Virus, Gonorrhea, Chlamydia, Syphilis
- Keywords
- Hepatitis C, HIV, sexually transmitted diseases, Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Apr 2028 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Integrated care | Experimental | Other: Integrated careStudy 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. |
| Treatment as usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide written consent
- PrEP exclusion: HIV positive test; HBV positive test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated careReceipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment. | Other | Integrated care |
Primary outcome
Infectious diseases screening uptake during intervention period
Time frame: 90 days
Proportion of Veterans who completed any screening for HIV, hepatitis C virus (HCV), gonorrhea, chlamydia, or syphilis during the intervention period
14 secondary outcomes
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
PrEP retention during the intervention period
Time frame: 90 days
PrEP retention during the follow-up period
Time frame: 270 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audun J Lier, MD principal investigator
Northport VA Medical Center, Northport, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care in people with Opioid Use Disorder and HIV, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audun J Lier, MD ((631) 261-4400 ext. 4827, audun.lier@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious diseases screening uptake during intervention period (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.