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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
Confirming HIV-negative status through proof of PrEP prescription
Being 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up conducted at 9-month follow-up
Awards & highlights

MOST Trial 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.Check my eligibility
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.See study design
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.

MOST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have proof of a PrEP prescription, confirming my HIV-negative status.
Select...
I am 18 years old or older.
Select...
I am diagnosed with opioid dependence and follow a prescribed medication treatment.

MOST Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
HIV prevention IMB model constructs questionnaire
HIV risk behaviors questionnaire
Other outcome measures
Drug Test via Urine toxicology

MOST 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
Group XVI: Condition 1Active Control2 Interventions
Standard CHRP Intervention Components

Find a Location

Who is running the clinical trial?

University of ConnecticutLead Sponsor
181 Previous Clinical Trials
157,789 Total Patients Enrolled
Michael Copenhaver, PhDPrincipal InvestigatorUniversity of Connecticut
1 Previous Clinical Trials
237 Total Patients Enrolled

Media Library

Community-Friendly Health Recovery Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05669534 — Phase 4
Opioid Use Disorder Research Study Groups: Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16
Opioid Use Disorder Clinical Trial 2023: Community-Friendly Health Recovery Program Highlights & Side Effects. Trial Name: NCT05669534 — Phase 4
Community-Friendly Health Recovery Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669534 — Phase 4

Frequently Asked Questions

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

Has Condition 2 been granted regulatory approval by the FDA?

"Due to the Phase 4 classification of Condition 2, our team have confidently assessed its safety with a score of 3."

Answered by AI

Are there any remaining openings for test subjects in this research?

"Affirmative. According to details found on clinicaltrials.gov, this medical study has been recruiting since March 1st 2023 and the latest edit was made on March 22nd of the same year. 256 patients are required for participation at one specific location."

Answered by AI

To what extent is the selection of participants for this trial being limited?

"Affirmative. The clinicaltrials.gov website confirms that this trial is currently recruiting patients, which began on March 1st 2023 and was last modified on March 22nd 2023. 256 individuals across a single site are required for the study to reach its enrollment goals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Michael Copenhaver 2023. "Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669534.
All > Mci > Prep
~171 spots leftby Jan 2027
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