Opioid Use Disorder, HIV, Hepatitis C Virus, Gonorrhea, Chlamydia, Syphilis, Sexually Transmitted Infection, Integrated Care, Medications for Opioid Use Disorder
Conditions
Keywords
Hepatitis C, HIV, sexually transmitted diseases, Opioid-Related Disorders
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.
Interventions
OTHERIntegrated care
Receipt of infectious diseases laboratory testing and/or PrEP for HIV within a single substance use disorder clinic appointment.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the integrated care intervention | 90 days | Proportion of Veterans who agreed that the integrated care intervention was a feasible care model for the substance use disorder clinic |
| Acceptability of the integrated care intervention | 90 days | Proportion of Veterans who agreed that the integrated care intervention was an acceptable care model for the substance use disorder clinic |
Countries
United States
Contacts
Primary ContactAudun J Lier, MD
Outcome results
None listed