Adapting the HOPE Online Support Intervention to Increase Uptake of Medications for Opioid Use Disorder

NCT ID: NCT04712981

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2025-10-31

Brief Summary

In a randomized controlled trial, with 3, 6-month and 1-year follow-up, this application aims to explore whether and how the HOPE intervention can be adapted to increase MOUD uptake among OUD patients, assess the effectiveness of using HOPE to increase MOUD requests, and analyze online community data to improve future intervention implementation and sustainability.

Detailed Description

The proposed study is a low-risk, randomized control trial to assess the efficacy of the HOPE (Harnessing Online Peer Education) intervention, an evidenced-based peer-led social media/online community intervention (e.g., Facebook Groups), to increase self-reported requests for medications for opioid use disorder (MOUD) among patients with moderate to severe opioid use disorder (OUD). Participants will be recruited using a variety of recruitment methods including social media sites (e.g., Facebook), referral by physicians, medical records, research study websites (e.g., UCIMC Clinical Trials website), and study flyers disseminated at various venues, including clinics, group meetings, and shelters. Once enrolled, participants will be randomly assigned to an intervention or control group. Intervention group participants will be invited to join a private and hidden (unable to be viewed or searched for by others) group on Facebook, with approximately 6 peer leaders included in the group. Those in the control group will be invited into a Facebook group, but without peer leaders. The intervention will last 12 weeks. Study measures will be collected at the beginning of the study (baseline), after the completion of the intervention (3 months), with follow up surveys at 6 and 12 months after the study.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

HOPE intervention peer-led online community

Group Type: EXPERIMENTAL

HOPE

Intervention Type: BEHAVIORAL

Peer leaders/role models will be trained in HOPE intervention fundamentals and assigned to online community groups with participants.

Control

Online community without HOPE intervention psychological components

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HOPE

Peer leaders/role models will be trained in HOPE intervention fundamentals and assigned to online community groups with participants.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years of age;

2. Resident of CA, NV, AZ, OR, WA;

3. English speakers only;

4. Has moderate to severe OUD;

5. Is not currently prescribed MOUD;

6. Reports using social media at least 2x per week;

7. Has, or is willing to create a Facebook/social media account and accept a friend request and group invite from our study social media page

2. Was a participant in phase I of the study

3. Participants with active, unstable opioid, alcohol, sedative, or other substance use and/or unstable medical or psychiatric conditions as assessed by the study questionnaires will be reviewed by the study physician consultants and will be excluded and referred for acute care including detoxification, if needed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Sean D Young

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean D Young, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

20205625

Identifier Type: -

Identifier Source: org_study_id

4R33AT010606

Identifier Type: NIH

Identifier Source: secondary_id

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