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Implementation Facilitation for Substance Use Disorders (WHAT-IF? Trial)

N/A
Waitlist Available
Led By David Fiellin, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV-infected
Receiving HIV care in the index clinic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

WHAT-IF? Trial Summary

This trial will study whether providing evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders to HIV patients in clinics routine increases uptake of these treatments.

Eligible Conditions
  • Substance Use Disorders

WHAT-IF? Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have HIV.
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You are currently receiving treatment for HIV at the clinic where the study is taking place.
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You must be 18 years or older.
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You have a history of addiction or currently struggle with addiction to tobacco, alcohol or opioids, regardless of whether you are receiving treatment for it.
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You are able to say "yes" to participate in the study after learning about it.
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You have been working at the HIV clinic involved in the study for at least 6 months.
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You are able to give permission for your participation in the study by speaking.
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You work for an organization that provides financial support for medical services to people with HIV for at least 6 months.

WHAT-IF? Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Provision of Addiction Treatments
Secondary outcome measures
Antiretroviral Therapy (ART) Receipt
Organizational Readiness
Provider Readiness
+4 more

WHAT-IF? Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Implementation FacilitationExperimental Treatment1 Intervention
We will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The time to implementation in a stepped wedge design is randomly assigned. Clinics are then followed prospectively to determine their outcome status..
Group II: Usual Care- ControlActive Control1 Intervention
We will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The first phase for all clinics is a control phase where clinic staff and patients engage in usual care. The time to implementation is randomly assigned. Each clinic is then followed prospectively to determine their outcome status.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Implementation Facilitation
2019
N/A
~8690

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,724,628 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,445 Previous Clinical Trials
2,590,138 Total Patients Enrolled
David Fiellin, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
3,999 Total Patients Enrolled

Frequently Asked Questions

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

Are there numerous healthcare facilities performing this research in the United States?

"Four medical institutions are currently recruiting for this trial: Haelen Center at Yale New Haven Hospital in New Haven, Immunology Center at Miriam Hospital in Providence, and SUNY Downstate Medical Center in Brooklyn. Furthermore, there are 4 additional recruitment sites."

Answered by AI

Is it feasible for individuals to join this clinical trial at present?

"Clinicaltrials.gov states that this medical study is no longer recruiting participants, as it was first posted on September 1st 2016 and last modified on October 6th 2021. However, 362 other trials are still searching for volunteers at the present time."

Answered by AI
Recent research and studies
~452 spots leftby Mar 2025