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Behavioral Intervention

PrEP for HIV Prevention in Opioid Use Disorder (MOST Trial)

Phase 4

Recruiting

Led By Michael Copenhaver, PhD

Research Sponsored by University of Connecticut

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up conducted at 9-month follow-up

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will help PWID on MOUD improve their HIV prevention skills, motivation, and behaviors.

Who is the study for?

This trial is for adults over 18 who inject drugs, are on opioid addiction treatment like methadone or buprenorphine, have started HIV prevention medication (PrEP) recently, and show mild cognitive issues. They must be able to read English and use a cell phone. People with dementia-like scores, psychosis, or suicidal/homicidal tendencies cannot join.

What is being tested?

The study tests four methods aimed at helping people who inject drugs process HIV prevention information better while they're on opioid disorder medications. It looks at how these methods affect their knowledge, motivation, skills related to HIV prevention behaviors.

What are the potential side effects?

While the trial focuses on behavioral interventions rather than medical treatments, side effects may relate to Pre-Exposure Prophylaxis (PrEP), which can include nausea, headache, stomach pain and weight loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ conducted at 9-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~conducted at 9-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and conducted at 9-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)

Pre-Exposure Prophylaxis Adherence via pharmacy refill data

Pre-Exposure Prophylaxis Adherence via self-report scale

Secondary study objectives

HIV prevention IMB model constructs questionnaire

HIV risk behaviors questionnaire

Other study objectives

Drug Test via Urine toxicology

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

16Treatment groups

Experimental Treatment

Active Control

Group I: Condition 9Experimental Treatment2 Interventions

Standard CHRP Intervention Components and Attention Components

Group II: Condition 8Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components

Group III: Condition 7Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components

Group IV: Condition 6Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components

Group V: Condition 5Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components

Group VI: Condition 4Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Information Processing Components, and Memory Components

Group VII: Condition 3Experimental Treatment2 Interventions

Standard CHRP Intervention Components and Memory Components

Group VIII: Condition 2Experimental Treatment2 Interventions

Standard CHRP Intervention Components and Information Processing Components

Group IX: Condition 16Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components

Group X: Condition 15Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Group XI: Condition 14Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Group XII: Condition 13Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components

Group XIII: Condition 12Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components

Group XIV: Condition 11Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Memory Components, and Attention Components

Group XV: Condition 10Experimental Treatment2 Interventions

Standard CHRP Intervention Components, Information Processing Components, and Attention Components