SIRI Checklist + Peer Coaching for HIV Prevention in Opioid Users
(SHAPE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: HIV positive, No OUD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Enhanced Peer Recovery Coach, SIRI Checklist for HIV prevention in opioid users?
Research shows that integrating care for HIV and opioid use disorder can improve patient outcomes, and peer recovery coach interventions have been effective in helping patients stay on treatment for opioid use disorder. Additionally, practice coaching has been shown to increase HIV testing in substance use treatment programs, which is crucial for prevention.
12345Is the SIRI Checklist + Peer Coaching safe for humans?
The SIRI Checklist and Enhanced Peer Recovery Coach have been used in hospital settings to support people who inject drugs, focusing on improving care and linking them to community services. While specific safety data for this exact combination isn't detailed, peer support programs in similar contexts have been generally well-received and considered helpful, with no major safety concerns reported.
678910How does the SIRI Checklist + Peer Coaching treatment for HIV prevention in opioid users differ from other treatments?
The SIRI Checklist + Peer Coaching treatment is unique because it combines a structured checklist approach with peer support to help opioid users prevent HIV, focusing on behavior change and peer interaction rather than solely on medication or technology-based interventions.
311121314Eligibility Criteria
This trial is for individuals over 18 with opioid use disorder who are HIV negative and have serious injection-related infections. They must be receiving care at UAB Hospital and able to give informed consent, not excluded due to acute illness or intoxication.Inclusion Criteria
I am 18 years old or older.
Receiving care at UAB Hospital
Have opioid use disorder (OUD)
+1 more
Exclusion Criteria
HIV positive
Unable to provide informed consent due to acute illness or intoxication
Do not have OUD
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Hospitalization and Initial Treatment
Participants receive addiction medicine protocol and peer recovery coaching while hospitalized. Surveys are conducted to evaluate attitudes and preferences toward OUD treatment and HIV prevention.
During hospitalization
Weekly in-person visits during hospitalization
Post-Hospital Follow-up
Participants continue to receive peer recovery coaching weekly in person, by phone, and/or via text messaging for up to 1 month after hospital discharge.
1 month
Weekly contact (in-person, phone, or text)
Follow-up
Participants are monitored for outpatient visits related to HIV and/or addiction services, and prescriptions for PrEP and MOUD are tracked.
3 months
Participant Groups
The study is testing a SIRI Checklist alone, an Enhanced Peer Recovery Coach alone, and the combination of both interventions. The goal is to improve addiction treatment and prevent infections in rural drug users by using hospital-based care models.
4Treatment groups
Experimental Treatment
Active Control
Group I: SIRI Checklist + Enhanced Peer Recovery CoachExperimental Treatment1 Intervention
A standardized checklist of clinical items to review by the attending hospitalist with participants.
Participants will receive the addiction medicine protocol 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.
Group II: SIRI ChecklistExperimental Treatment1 Intervention
A standardized checklist of clinical items to review by the attending hospitalist with participants.
Group III: Enhanced Peer Recovery CoachExperimental Treatment1 Intervention
Participants will receive the addiction medicine protocol 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.
Group IV: Standard of CareActive Control1 Intervention
Participants will receive the stand hospital care while in-patient.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. [2023]Integration of HIV- and opioid use disorder (OUD)-related care is associated with improved patient outcomes. Our goal was to develop a novel instrument for measuring quality of integration of HIV and OUD-related care that would be applicable across diverse care settings.
A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs. [2023]Background People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the United States offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. Methods/Design In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on: the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e,g., HIV and HCV testing at six-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. Discussion Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. Trial registration ClinicalTrials.gov: NCT03135886. (02 05 2017).
HIV testing and sexual risk reduction counseling in office-based buprenorphine/naloxone treatment. [2013]We assessed the feasibility and preliminary efficacy of human immunodeficiency virus (HIV) testing with sexual risk reduction counseling for opioid-dependent patients initiating office-based buprenorphine/naloxone treatment.
A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]Patients with opioid use disorder (OUD) are increasingly being hospitalized for acute medical illnesses. Despite initiation of medications for OUD (MOUDs), many discontinue treatment after discharge. To evaluate whether a psychosocial intervention can improve MOUD retention after hospitalization, we conducted a pilot randomized controlled trial of a peer recovery coach intervention.
Mobile Technology to Increase HIV/HCV Testing and Overdose Prevention/Response among People Who Inject Drugs. [2020]The United States faces dramatically increasing rates of opioid overdose deaths, as well as persistent ongoing problems of undiagnosed HIV and HCV infection. These problems commonly occur together in substance using populations that have limited, if any, access to primary care and other routine health services. To collectively address all three issues, we developed the Mobile Intervention Kit (MIK), a tablet computer-based intervention designed to provide overdose prevention and response training and to facilitate HIV/HCV testing in community settings. Intervention content was produced in collaboration with experienced street outreach workers who appear onscreen in a series of educational videos. A preliminary pilot test of the MIK in a Bronx, NY street outreach syringe exchange program found the MIK is feasible and highly acceptable to a population of people who inject drugs. Participants accepted HIV and HCV testing post-intervention, as well as naloxone training to reverse overdose events. Pre-post tests also showed significant increases in knowledge of overdose prevention, HIV testing procedures, and asymptomatic HCV infection. Future iterations of the MIK can be optimized for use in community as well as clinical settings nationwide, and perhaps globally, with a focus on underserved urban populations.
Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. [2023]Opioid use disorder (OUD) is a major public health emergency in the United States. In 2020, 2.7 million individuals had an OUD. Medication for opioid use disorder is the evidence-based, standard of care for treating OUD in outpatient settings, especially buprenorphine because it is effective and has low toxicity. Buprenorphine is increasingly prescribed in primary care, a setting that provides greater anonymity and convenience than substance use disorder treatment centers. Yet two-thirds of people who begin buprenorphine treatment discontinue within the first six months. Treatment dropout elevates the risks of return to use, infections, higher levels of medical care and related costs, justice system involvement, and death. One promising form of retention support is peer service programs. Peers combine their lived experience of substance use and recovery with formal training to help patients engage and persist in OUD treatment. They provide a range of services, including health education, encouragement and empathy, coping skills, recovery modeling, and concrete assistance in overcoming the situational barriers to retention. However, guidance is needed to define the peer role in primary care, the specific tasks peers should perform, the competencies those tasks require, training and professional development needs, and peer performance standards. Guidance also is needed to integrate peers into the care team, allocate and coordinate responsibilities among care team members, manage peer operations and workflow, and facilitate effective team communication. Here we describe a peer support program in the University of Pennsylvania Health System (UPHS or Penn Medicine) network of primary care practices. This paper details the program's core components, values, and activities. We also report the organizational challenges, unresolved questions, and lessons for the field in administering a peer support program to meet the needs of patients served by a large, urban medical system with an extensive suburban and rural catchment area. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov registration: NCT04245423.
A Study Protocol to Increase Engagement in Evidence Based Hospital and Community Based Care Using a Serious Injection Related Infections (SIRI) Checklist and Enhanced Peer for Hospitalized PWID (ShaPe). [2023]With the opioid crisis, surging methamphetamine use, and healthcare disruptions due to SARS-CoV-2, serious injection related infections (SIRIs), like endocarditis, have increased significantly. Hospitalizations for SIRI provide a unique opportunity for persons who inject drugs (PWID) to engage in addiction treatment and infection prevention, yet many providers miss opportunities for evidence-based care due to busy inpatient services and lack of awareness. To improve hospital care, we developed a 5-item SIRI Checklist for providers as a standardized reminder to offer medication for opioid use disorder (MOUD), HIV and HCV screening, harm reduction counseling, and referral to community-based care. We also formalized an Intensive Peer Recovery Coach protocol to support PWID on discharge. We hypothesized that the SIRI Checklist and Intensive Peer Intervention would increase use of hospital-based services (HIV, HCV screening, MOUD) and linkage to community-based care: PrEP prescription, MOUD prescription, and related outpatient visit(s).
Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). [2022]Individuals with opioid use disorder experiencing a non-fatal opioid-overdose (OOD) are at heightened risk for future OODs; there are no interventions to facilitate treatment enrollment for these patients. Our goal was to develop and initially test the 'tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses' (TTIP-PRO), a computer-facilitated, peer-delivered, individually tailored secondary prevention intervention designed to: (i) encourage patients to initiate medication-assisted treatment (MAT) and (ii) increase OOD knowledge. A pre-post-study assessed TTIP-PRO-content acceptability and software performance. Two Peer Interventionists, who were abstinent from illicit opioids, enrolled in MAT and had experience with OOD, were recruited from a MAT clinic. Recruitment letters were sent to patients treated for OOD in a hospital emergency department within the prior 8 months. Eight patients received TTIP-PRO and completed pre-/post-assessment. Peer Interventionists completed training within 4 h and reported high satisfaction with TTIP-PRO. There were no performance issues with the software. All participants rated TTIP-PRO as 'very helpful'. Participants' OOD knowledge increased significantly, with 69.9% correct responses pre-TTIP-PRO and 93.6% post-TTIP-PRO. Interest in receiving MAT, measured on a 10-point scale, increased from 8.1 to 9.5, but this change was not statistically significant. Further development and testing of TTIP-PRO appears warranted.
Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. [2023]Label="Background" NlmCategory="UNASSIGNED">Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment.
A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. [2022]Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
Past-year medical and non-medical opioid use by HIV status in a nationally representative US sample: Implications for HIV and substance use service integration. [2023]In the context of the continued overdose epidemic, recent population estimates of opioid use in highly affected groups, such as people at risk for or people living with HIV (PLWH), are essential for service planning and provision. Although nonmedical opioid use is associated with HIV transmission and with lowered adherence and care engagement, most studies rely on clinic-based samples and focus on medical use of opioids only. We examine associations between opioid-related outcomes by HIV status in a community-based nationally representative sample.
Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care. [2020]This study was part of a national, multisite demonstration project evaluating the impact of integrated buprenorphine/naloxone treatment and HIV care. The goals of this study were to describe the baseline demographic, clinical, and substance use characteristics of the participants and to explore HIV transmission risk behaviors in this group.
Acceptability and Feasibility of a Mobile Phone Application to Support HIV Pre-exposure Prophylaxis Among Women with Opioid Use Disorder. [2023]Despite evidence supporting HIV pre-exposure prophylaxis (PrEP) effectiveness, very few women with opioid use disorder (OUD) take PrEP. Interventions that improve medication assisted treatment (MAT) uptake and adherence may also be beneficial for PrEP. The reSET-O mobile phone app is a component of the evidence-based Therapeutic Education System, which improves retention and abstinence for people with OUD. To better understand use of this mobile health tool as a support for PrEP among women with OUD, pre-implementation contextual inquiry is needed. Therefore, we set out to assess target user characteristics, implementation barriers, feasibility, and acceptability of reSET-O. We recruited women with OUD receiving care from a community-based organization in Philadelphia to complete semi-structured interviews. All participants were prescribed reSET-O. We interviewed 20 participants (average age 37 years; 70% white, 15% Hispanic, 5% Black) from 5/2021 to 2/2022. We used an integrated analysis approach combining modified grounded theory and implementation science constructs. Half reported recent injection drug use, and 6 were taking buprenorphine. Mental health symptoms were common, and half described engaging in transactional sex. The majority expressed strong interest in PrEP. Participants reported the app would be highly acceptable for PrEP and MAT adherence support, but only two redeemed the prescription. The most common barriers included phone and internet access. Our findings highlight potential implementation challenges for the use of such an app to support PrEP use in this population. Poor uptake of the app at follow-up indicates that initial prescription redemption is a major barrier to reSET-O implementation.
Interest in use of mHealth technology in HIV prevention and associated factors among high-risk drug users enrolled in methadone maintenance program. [2018]The adoption of mobile technologies for health (mHealth) in healthcare has grown considerably in recent years, but systematic assessment of interest in the use of mHealth in HIV prevention efforts among people who use drugs (PWUD) is lacking. We therefore examined interest in use of mHealth technology in HIV prevention and associated individual-level factors among high-risk PWUD enrolled in methadone maintenance program. A total of 400 HIV-negative PWUD, who reported drug- and/or sex-related risk behaviors completed a standardized assessment using audio computer assisted self-interview (ACASI). Results revealed significant interest in using mHealth-based approaches for specific purposes, including: to receive medication reminders (72.3%), to receive information about HIV risk reduction (65.8%), and to assess HIV risk behaviors (76.5%). Multivariate analysis showed that interest in receiving medication reminders was associated with currently taking medication and being neurocognitively impaired, whereas interest in receiving HIV-risk reduction information was associated with being non-white, married, and perceiving the person was at high-risk for contracting HIV. Similarly, participants' interested in using mHealth for HIV risk behavior assessment was associated with having recently visited a healthcare provider and exhibiting depressive symptoms. Overall, this study demonstrated that high-risk PWUD are interested in using mHealth-based tools as a key part of an HIV prevention approach within a common type of drug treatment settings. Thus, formative research on preferences for design and functionality of mHealth-based HIV prevention tools are now needed, followed by practical development, implementation, and evaluation of these new intervention strategies.