- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03057119
Feasibility of SBIRT-PN
Feasibility of Screening, Brief Intervention, Referral to Treatment With Peer Navigation (SBIRT-PN) for Underserved HIV+ Adults 50+ in Primary Care Settings.
Study Overview
Status
Detailed Description
The current project will pilot SBIRT with a peer navigator (SBIRT-PN) versus treatment at usual (TAU) to increase substance use treatment engagement among HIV-positive adults aged 50 years and older. The investigators will recruit patients from the Southern HIV and Alcohol Research Consortium (SHARC) HIV primary care clinic network.
In order to develop effective substance use intervention models for HIV care settings the specific aims of the current project are:
Aim1: Examine the feasibility of the SBIRT-PN model at the UF Health Infectious Disease-Medical Specialties Clinic. The investigators hypothesize that the SBIRT-PN model will demonstrate high feasibility within the UF Health Infectious Disease - Medical Specialties Clinic.
Aim2a: Assess the acceptability of SBIRT-PN. The investigators hypothesize that SBIRT-PN will demonstrate high acceptability among patients enrolled in this condition.
Aim2b: Assess the acceptability of SBIRT-PN among HIV-positive individuals by age cohort (younger vs older). The investigators hypothesize that SBIRT-PN will demonstrate higher acceptability among older HIV-positive patients enrolled in this condition.
Aim3: Assess influence of SBIRT-PN model on treatment engagement and substance use compared to enhanced treatment as usual (TAU).The investigators hypothesize that those in the SBIRT-PN condition will evidence greater treatment engagement and a reduction in substance use.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Jacksonville, Florida, United States, 32207
- CAN Community Health
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Lake City, Florida, United States, 32055
- Department of Health in Columbia County",
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving care at an Infectious disease Medical Clinic
- HIV-positive (seropositive confirmed by medical records)
- have a substance misuse screening score indicating moderate or high risk.
Exclusion Criteria:
- lack fluency in English
- are unwilling to provide information for follow-up
- plan to leave the area within 6 months
- already have a referral to treatment from another provider
- unable to provide informed consent due to cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBIRT Intervention
The interventionist will discuss substance use and misuse, HIV, and the interaction of aging and substance use; will give the patient feedback on their NM-ASSIST score and assess the patient's readiness to change based on Prochaska's stages of change; motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.
Identifying and prioritizing need; problem-solving techniques to help patients identify which services may best help them work towards their goals; will use a referral resource guide to provide the contact information of agency representatives and help the patient formulate a plan for follow-up.
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The interventionist will discuss substance use and misuse and the influence of substance use on self care.
The interventionist will give the patient feedback on their ASSIST score and assess the patient's readiness to change based on Prochaska's stages of change.
Other Names:
The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.
The interventionist will use problem-solving techniques to help patients identify which services may best help them work towards their goals.
Services will include (but are not limited to) emergency crisis services, counseling to deal with substance use, referral to local self-help groups (Alcoholics Anonymous, Narcotics Anonymous, etc.), legal assistance, faith-based counseling, mental health counseling or inpatient substance use treatment.
The interventionist will use a referral resource guide to provide the contact information of agency representatives and help the patient formulate a plan for follow-up.
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No Intervention: Treatment as Usual
Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group.
These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Ranking Intervention as Acceptable
Time Frame: 30 Days
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To examine ratings of acceptability, the investigators will use the overall acceptability score and percentage of acceptability.
Overall acceptability will be assessed by summing ratings from the 10-item questionnaire to provide a total intervention acceptability score for the intervention, such that acceptability scores for the intervention could range from 10 (low acceptability) to 50 (high acceptability).
The intervention will be considered to have acceptability if 80% of the participants rank the intervention as acceptable (i.e., 4 or higher) on 80% or more of the scale items.
The investigators will then examine each question of the Acceptability Questionnaire separately to determine strengths and weaknesses of the intervention.
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30 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Obtained Formal Substance Use Treatment
Time Frame: 6 Months
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Participants will self-report if they obtained formal substance use treatment (i.e., any services sought to address substance use from individual therapy to 12 step fellowships).
The investigators will request treatment facility information and permission to verify treatment.
Once treatment has been verified, treatment engagement will be coded as 0= no formal treatment 1= formal treatment engagement
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6 Months
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Number of Participants Who Used Different Types of Substances (Self-Reported)
Time Frame: 6 Months
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A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used.
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6 Months
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Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Time Frame: 6 Months
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A CLIA 12-Panel Instant Drug Test Cup (CLIAwaivedTM, San Diego, CA), which tests for the presence of 12 common substances in the urine will be used.
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6 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicole Ennis, PhD, Florida State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201701252 - N
- KL2TR001429 (U.S. NIH Grant/Contract)
- 1K23DA039769-01 (U.S. NIH Grant/Contract)
- OCR25582 (Other Identifier: UF OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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