SIRI Checklist + Peer Coaching for HIV Prevention in Opioid Users

(SHAPE Trial)

Overseen By Mariel Parman, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: HIV positive, No OUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{3 11 12 13 14}

Eligibility 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

Receiving care at UAB Hospital

Have opioid use disorder (OUD)

I am HIV negative and have a serious infection from injecting drugs.

Exclusion Criteria

HIV positive

Unable to provide informed consent due to acute illness or intoxication

Do not have OUD

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

Treatment Details

Interventions

• Enhanced Peer Recovery Coach
• SIRI Checklist

Trial Overview 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.

Participant Groups

Group I: SIRI Checklist + Enhanced Peer Recovery Coach Experimental Treatment 1 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 Checklist Experimental Treatment 1 Intervention

A standardized checklist of clinical items to review by the attending hospitalist with participants.

Group III: Enhanced Peer Recovery Coach Experimental Treatment 1 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 Care Active Control 1 Intervention

Participants will receive the stand hospital care while in-patient.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

A study involving 51 opioid treatment programs is testing two practice coaching interventions to improve on-site HIV and HCV testing, which is crucial for individuals with substance use disorders who are at high risk for HIV.

The research aims to enhance the implementation and sustainability of testing practices, potentially leading to better health outcomes and reduced rates of HIV and HCV infections among this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Frimpong, JA., Parish, C., Feaster, DJ., et al.[2023]

A 14-week study involving 30 opioid-dependent patients showed that integrating HIV testing with sexual risk reduction counseling during buprenorphine/naloxone treatment is feasible, with high participation rates in both counseling approaches.

Both Brief Sexual Risk Management (BSRM) and Enhanced Sexual Risk Management (ESRM) were effective in terms of HIV testing and counseling completion, but BSRM was quicker, suggesting it could be a more efficient option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV testing and sexual risk reduction counseling in office-based buprenorphine/naloxone treatment. Edelman, EJ., Moore, BA., Caffrey, S., et al.[2013]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

The Mobile Intervention Kit (MIK) is a tablet-based program that effectively combines overdose prevention training with HIV and HCV testing, showing high acceptability among people who inject drugs in a Bronx outreach program.

Participants demonstrated significant increases in knowledge about overdose prevention and testing procedures after using the MIK, indicating its potential as a valuable tool for addressing opioid overdose and viral infections in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Technology to Increase HIV/HCV Testing and Overdose Prevention/Response among People Who Inject Drugs. Aronson, ID., Bennett, A., Marsch, LA., et al.[2020]

Buprenorphine is an effective and low-toxicity treatment for opioid use disorder (OUD), but two-thirds of patients discontinue treatment within six months, increasing risks of relapse and other negative outcomes.

Peer support programs, which utilize individuals with lived experience of substance use and recovery, can enhance patient retention in OUD treatment by providing education, encouragement, and assistance in overcoming barriers, but clear guidance is needed for their integration into primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. Harris, RA., Campbell, K., Calderbank, T., et al.[2023]

The study introduces a 5-item SIRI Checklist and an Intensive Peer Recovery Coach protocol aimed at improving hospital care for persons who inject drugs (PWID) with serious injection-related infections (SIRIs), focusing on increasing access to addiction treatment and infection prevention services.

This feasibility study will assess the effectiveness of these interventions in enhancing the use of hospital-based services and linking PWID to community care, with a goal of improving public health outcomes in rural and Southern regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Baldwin, M., Jeziorski, M., Parman, M., et al.[2023]

The tailored telephone intervention delivered by peers (TTIP-PRO) was well-received by participants, with all eight patients finding it 'very helpful' and showing a significant increase in their knowledge about opioid overdoses, from 69.9% to 93.6% correct responses after the intervention.

While interest in starting medication-assisted treatment (MAT) increased from 8.1 to 9.5 on a 10-point scale, this change was not statistically significant, indicating that further development and testing of TTIP-PRO is needed to effectively encourage MAT enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Winhusen, T., Theobald, J., Lewis, D., et al.[2022]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

A 20-minute telephone-delivered peer recovery support service (PRSS) intervention led to a higher enrollment in medication for opioid use disorder (MOUD) among participants, with 32.5% of PRSS participants enrolling compared to 17.5% in the control group.

Participants receiving PRSS were significantly less likely to experience an opioid overdose (OOD) within 12 months, with only 12.5% reporting an OOD compared to 32.5% in the control group, indicating the potential effectiveness of PRSS in enhancing safety for individuals with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Winhusen, T., Wilder, C., Kropp, F., et al.[2022]

In a study of over 213,000 individuals from the National Survey on Drug Use and Health, people living with HIV (PLWH) showed a significantly higher prevalence of nonmedical opioid use (11.1%) compared to HIV-negative individuals (4.2%), indicating a critical public health concern.

PLWH were found to have more than three times the risk of engaging in nonmedical opioid use compared to HIV-negative individuals, highlighting the need for integrated prevention and treatment services that address both HIV and substance use to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. West, BS., Diaz, JE., Philbin, MM., et al.[2023]

In a study of 386 individuals receiving treatment for opioid dependence, 24% of those on buprenorphine/naloxone reported engaging in unprotected sex, highlighting a significant risk for HIV transmission.

Factors such as alcohol use, homelessness, and anxiety were linked to higher rates of risky behaviors, indicating that comprehensive care addressing substance use and social issues is crucial for reducing HIV transmission among opioid-dependent patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care. Chaudhry, AA., Botsko, M., Weiss, L., et al.[2020]

A study involving 20 women with opioid use disorder (OUD) revealed a strong interest in HIV pre-exposure prophylaxis (PrEP), indicating a potential demand for this preventive treatment among this population.

Despite the high acceptability of the reSET-O mobile app for supporting PrEP and medication-assisted treatment (MAT), only two participants redeemed their prescription, highlighting significant barriers such as access to phones and the internet that hinder implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Mobile Phone Application to Support HIV Pre-exposure Prophylaxis Among Women with Opioid Use Disorder. Richterman, A., Ghadimi, F., Teitelman, AM., et al.[2023]

A study involving 400 HIV-negative people who use drugs (PWUD) showed strong interest in mobile health (mHealth) technologies for HIV prevention, particularly for medication reminders (72.3%) and HIV risk reduction information (65.8%).

Factors influencing this interest included current medication use and neurocognitive impairment for medication reminders, while demographic factors like being non-white and married were linked to interest in HIV risk reduction information, highlighting the need for tailored mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in use of mHealth technology in HIV prevention and associated factors among high-risk drug users enrolled in methadone maintenance program. Shrestha, R., Karki, P., Copenhaver, M.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

HIV testing and sexual risk reduction counseling in office-based buprenorphine/naloxone treatment. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Technology to Increase HIV/HCV Testing and Overdose Prevention/Response among People Who Inject Drugs. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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]

10. Ireland pubmed.ncbi.nlm.nih.gov

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]

11. United States pubmed.ncbi.nlm.nih.gov

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]

12. United States pubmed.ncbi.nlm.nih.gov

Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Mobile Phone Application to Support HIV Pre-exposure Prophylaxis Among Women with Opioid Use Disorder. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Interest in use of mHealth technology in HIV prevention and associated factors among high-risk drug users enrolled in methadone maintenance program. [2018]