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Diagnostic Test

Mobile Health Services for Opioid Use Disorder (INTEGRA Trial)

N/A

Waitlist Available

Research Sponsored by HIV Prevention Trials Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to successfully complete an Assessment of Understanding

Willing to start MOUD treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks and 52 weeks

Awards & highlights

INTEGRA Trial Summary

This trial will test whether a mobile health delivery unit can help people with opioid use disorder access and stick to their medication regimens.

Who is the study for?

This trial is for people aged 18-60 who inject drugs and have opioid use disorder. Participants must be willing to start treatment, not have received similar treatments in the last month, and provide contact information. They should also either share injection equipment or have unprotected sex with partners of unknown HIV status.Check my eligibility

What is being tested?

The INTEGRA study tests a mobile health unit's ability to deliver integrated services including medications for opioid addiction (MOUD), HIV prevention (PrEP) and treatment, STI testing/treatment, hepatitis care, harm reduction services, primary care, and COVID-19 testing.See study design

What are the potential side effects?

Potential side effects may include reactions related to medication for opioid addiction such as nausea or drowsiness; PrEP-related issues like stomach pain or headaches; and general risks associated with vaccines or medical interventions.

INTEGRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and complete a knowledge test about my treatment.

Select...

I am willing to start medication for opioid use disorder.

Select...

I am between 18 and 60 years old.

INTEGRA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks and 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks and 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate whether the intervention increases use of PrEP among people without HIV

Secondary outcome measures

Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks

Assess whether the intervention increases the proportion of participants with undetectable HCV RNA among those with chronic HCV infection at enrollment

Document the impact of the COVID-19 epidemic on participants' experiences of seeking, obtaining and/or maintaining health services, housing, food security and drugs

+15 more

INTEGRA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated health services delivered in the mobile unit and peer navigationExperimental Treatment11 Interventions

Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.

Group II: Peer navigation to connect them to health services available at community-based agenciesActive Control7 Interventions

Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peer navigation

2016

Completed Phase 4

~220

HIV testing

2013

N/A

~4590

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,268 Previous Clinical Trials

5,480,682 Total Patients Enrolled

HIV Prevention Trials NetworkLead Sponsor

30 Previous Clinical Trials

568,254 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,183 Total Patients Enrolled

Media Library

COVID-19 testing and referral for further evaluation, care and/or treatment (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04804072 — N/A

Opioid Use Disorder Research Study Groups: Peer navigation to connect them to health services available at community-based agencies, Integrated health services delivered in the mobile unit and peer navigation

Opioid Use Disorder Clinical Trial 2023: COVID-19 testing and referral for further evaluation, care and/or treatment Highlights & Side Effects. Trial Name: NCT04804072 — N/A

COVID-19 testing and referral for further evaluation, care and/or treatment (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804072 — N/A

Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04804072 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment for this investigation underway?

"This research endeavour, which was initially listed on June 2nd 2021, is currently not seeking participants according to clinicaltrials.gov. Nevertheless, there are 900 other trials that require volunteers at this moment in time."

Answered by AI

Is enrollment open to adults aged 40 and above for this trial?

"The participant requirements for this study set the lower age limit at 18 and cap the upper age range at 60."

Answered by AI

Am I qualified to join this clinical trial?

"To be eligible for this study, participants must have HIV and lie within the age bracket of 18 to 60. In total, 860 individuals are being sought out."

Answered by AI

How populated is the geographical scope of this investigation in North America?

"This research is being conducted at UCLA Vine Street Clinic in LA, George Washington University CRS in DC, Penn Prevention CRS in Philadelphia and additional 5 sites."

Answered by AI