HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
Conditions
Brief summary
The purpose of this study is to develop and test a serious injection-related injections (SIRI) checklist aimed at increasing evidence-based treatment for rural people who use drugs (PWUD) including innovative, long-acting injectable agents. The central hypothesis is that hospital-based care models can successfully engage rural and Southern (PWUD) in effective addiction treatment and infection prevention. The activities in this study will be foundational to Ending the HIV epidemic in rural states.
Detailed description
Aim 1: We will conduct a prospective study of 60 PWUD hospitalized at UAB. Using a standardized survey, we will elicit HIV risk behaviors, substance use, and HIV-related stigma. We will use the 14-item Behavioral Risk Assessment for Infectious Diseases (BRAID) scale, which queries drug use and sexual behaviors while using drugs. We will also collect clinical and patient reported data related to infections (bacterial, viral), PrEP use, HCV treatment, and medication for opioid use disorder (MOUD). We will query perception of HIV risk, PrEP awareness, and interest. Surveys will be completed electronically in private hospital rooms to reduce social desirability bias. Aim 2: We will conduct surveys with 60 PWUD hospitalized at UAB to evaluate attitudes and preferences toward opioid use disorder (OUD) treatment and HIV prevention, including long-acting injectable formulations. We will explore interest and preferences related to hospital initiation of each medication. Each session will include open-ended questions on barriers, such as stigma, and opportunities for increasing evidence-based care including HIV prevention and addiction treatment. Aim 3: The SIRI Checklist will build on the existing standard of care for SIRI, Addiction Medicine and ID consultation, by adding a standardized reminder to offer MOUD, PrEP, and arrange appropriate community-based care with both Addiction and ID providers. SIRI Checklist will be inspired by the iCARE checklist, developed for endocarditis in PWID, but will be applicable for all PWUD and will incorporate HIV prevention education and linkage to care, including Hepatitis C (HCV) treatment. The checklist will be integrated into the provider's documentation using a smartphrase text for ease of use and standardization. Of the 60 participants we will randomize them to SIRI checklist (15), SIRI checklist plus enhanced Peer Recovery Coach (15), enhanced Peer Recovery Coach (15), or standard of care (15).
Interventions
BEHAVIORALSIRI Checklist
A standardized checklist of clinical items to review by the attending hospitalist with participants.
BEHAVIORALEnhanced Peer Recovery Coach
Participants will receive the addiction medicine standard of care plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.
BEHAVIORALSIRI Checklist + Enhanced Peer Recovery Coach
A standardized checklist of clinical items to review by the attending hospitalist with participants. Participants will receive the addiction medicine standard of care plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* We will include 60 PWUD with serious injection related infections (SIRI) who are HIV negative, ≥ 18 years old, have opioid use disorder (OUD) and receiving care at UAB Hospital
Exclusion criteria
* We will exclude those unable to provide informed consent due to acute illness or intoxication, those who don't have OUD, and those who are HIV positive in order to inform HIV prevention interventions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Assessment | From enrollment to 3 month post-enrollment | We will conduct exit interviews to assess provider perspectives of SIRI Checklist. We will query addiction, infectious diseases, and primary providers using a standard survey. Open-ended questions will solicit feedback on specific aspects of the checklist or delivery that need to be addressed, edited, or removed before a subsequent randomized controlled study. We will conduct a 3 month follow up survey of participants to assess use of PrEP, addiction treatment, and healthcare utilization. |
| Feasibility Assessment | From enrollment to 3 months post-enrollment | Feasibility will be measured via recruitment and retention of participants, completion of each portion of the intervention (baseline surveys and follow up assessments), and ability to contact patients post-discharge for intensive Peer support and/or completion of follow up assessments. We will also evaluate the ability to extract documentation of the SIRI Checklist and Peer documentation provider notes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prescriptions for PrEP (Pre-exposure Prophylaxis) | Enrollment until 3 months post-enrollment. | The study team will abstract documentation in the electronic medical record of prescription for PrEP up to 3 months post-enrollment. Data extraction will be limited to services provided in the UAB health system. |
| Number of Prescription for Medications for Opioid Use Disorder (MOUD) | Enrollment until 3 months post-enrollment. | The study team will abstract documentation in the electronic medical record of any prescription for MOUD up to 3 months post-enrollment. Data extraction will be limited to services provided in the UAB health system. |
| Number of Outpatient Visit(s)Attended Related to HIV and/or Addiction Services Following Hospitalization. | Enrollment until 3 months post-enrollment. | The study team will abstract documentation of any outpatient visit(s) related to HIV and/or addiction services following hospitalization. Data extraction will be limited to services provided in the UAB health system. |
Countries
United States
Participant flow
Recruitment details
Participants will be recruited following hospitalization for SIRI at UAB Hospital. Our research coordinator will meet biweekly with the Addiction Medicine social worker and/or nurse practitioner, to identify eligible PWID who express interest in study participation. The research team member will then discuss the study with those who are eligible, and if the participant expresses interest, the informed consent process will be completed.
Pre-assignment details
Inclusion Criteria: We will include 60 PWID with serious injection related infections (SIRI) who are HIV negative, ≥ 18 years old and receiving care at UAB Hospital for each of the three aims. Exclusion Criteria: We will exclude those unable to provide informed consent due to acute illness or intoxication and those who are living with HIV in order to inform HIV prevention interventions. Eligible participants provided written informed consent prior to randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 8.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 1 / 15 | 1 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
None listed