NCT03175640

Brief Summary

The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

2.5 years

First QC Date

May 18, 2017

Last Update Submit

December 17, 2020

Conditions

Opioid-Related DisordersDrug Overdose

Outcome Measures

Primary Outcomes (1)

  • Change in naloxone prescribing behavior

    Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.

    baseline to 6 months

Secondary Outcomes (6)

  • Change in perception about pharmacotherapy for opioid use disorder; 6-month

    baseline to 6 months

  • Change in perception about pharmacotherapy for opioid use disorder; 12-month

    baseline to 12 months

  • Change in prescribing motivation; 6 months

    baseline to 6 months

  • Change in prescribing motivation; 12 months

    baseline to 12 months

  • Change in prescriber training

    baseline to 12 months

  • +1 more secondary outcomes

Study Arms (1)

Implementation intervention

EXPERIMENTAL
Behavioral: Implementation intervention

Interventions

Implementation interventionBEHAVIORAL

The implementation intervention includes peer-to-peer training, post-training outreach, proactive expert support, and assistance with addressing environmental barriers.

Implementation intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinicians and staff of HIV practice sites that:
  • Receive Ryan White Funding;
  • Treat adults with HIV;
  • Have 3 or more prescribing clinicians;
  • Have an electronic medical record (EMR) with an electronic medication list.

You may not qualify if:

  • Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Massachusetts Medical School - Baystate

Springfield, Massachusetts, 01199, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Jawa R, Walley AY, Wilson DJ, Green TC, McKenzie M, Hoskinson R Jr, Bratberg J, Ramsey S, Rich JD, Friedmann PD. Prescribe to Save Lives: Improving Buprenorphine Prescribing Among HIV Clinicians. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):546-552. doi: 10.1097/QAI.0000000000003001.

    PMID: 35587832DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersDrug Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPrescription Drug MisuseDrug Misuse

Study Officials

  • Peter D Friedmann, MD, MPH

    University of Massachusetts Medical School - Baystate

    PRINCIPAL INVESTIGATOR

  • Josiah D Rich, MD, MPH

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Research Officer and Endowed Chair for Clinical Research

Study Record Dates

First Submitted

May 18, 2017

First Posted

June 5, 2017

Study Start

July 12, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

The investigators will make study data available to the community of scientists and the public in keeping with NIDA policies. After all data have been collected and the results of the major papers are in press, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by Dr. Friedmann to ensure that it meets reasonable standards of scientific integrity. Ultimately, it is anticipated that de-identified data and codebooks will be warehoused and available through the ICPSR and SAMHDA websites. This data sharing plan will comply with the requirements of the privacy rule and federal regulations under HIPAA and 42 CFR Part 2 that govern the protection of individually identifiable information.

Locations

US(2)