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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

No Placebo-Only Group

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.

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.

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.

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.

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I am willing to start medication for opioid use disorder.

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I am between 18 and 60 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Completed Phase 4

~4710