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Feasibility of SBIRT-PN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057119
Recruitment Status : Active, not recruiting
First Posted : February 17, 2017
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nicole Ennis, Florida State University

Brief Summary:
Substance misuse is a common problem among HIV+ individuals. Research suggests that a Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing substance misuse in the general older adult population; however these findings have not been verified in the more vulnerable HIV+ older adult population. The present study seeks to address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for older HIV+ adults in a in a primary care setting. Individual reductions in alcohol and drug use can have significant effects on public health and safety when observed over a large population at risk for substance use problems. With wider dissemination statewide, a relatively low-cost intervention such as SBIRT could offer demonstrated benefits in this population.

Condition or disease Intervention/treatment Phase
Substance Use HIV/AIDS Older Adults Behavioral Intervention Infectious Disease Behavioral: Psycho-educational content (5 Minutes) Behavioral: Readiness Assessment (10 minutes) Behavioral: Goal-Setting (5 minutes) Behavioral: Identifying and prioritizing needs (5 minutes) Behavioral: Explanation of Peer Navigator and Session wrap (5 minutes) Not Applicable

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 among providers 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A repeated measures randomized control trial design to compare patient outcomes at baseline as well as 3 and 6 months post-intervention
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Feasibility of Screening, Brief Intervention, Referral to Treatment With Peer Navigation (SBIRT-PN) for Underserved HIV+ Adults 50+ in Primary Care Settings.
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Behavioral: Psycho-educational content (5 Minutes)
The interventionist will discuss substance use and misuse and the influence of substance use on self care.

Behavioral: Readiness Assessment (10 minutes)
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 Name: Prochaska's stages of change.

Behavioral: Goal-Setting (5 minutes)
The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.

Behavioral: Identifying and prioritizing needs (5 minutes)
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.

Behavioral: Explanation of Peer Navigator and Session wrap (5 minutes)
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.

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.



Primary Outcome Measures :
  1. Feasibility Calculation & Acceptability Questionaire [ Time Frame: 30 Days ]
    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.


Secondary Outcome Measures :
  1. Substance Use Treatment Engagement [ Time Frame: 6 Months ]
    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

  2. Substance use NIDA STTR Drug and Alcohol Use Measure [ Time Frame: 3 to 6 Months ]
    A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used. It will assess quantity and frequency of types of substances used in the prior 30 days.

  3. Biologically Confirmed Drug Use [ Time Frame: 3 to 6 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057119


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Department of Health in Columbia County",
Lake City, Florida, United States, 32055
Sponsors and Collaborators
Florida State University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Nicole Ennis, PHD Florida State University
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Responsible Party: Nicole Ennis, Associate Professor, Florida State University
ClinicalTrials.gov Identifier: NCT03057119    
Other Study ID Numbers: IRB201701252 - N
1K23DA039769-01 ( U.S. NIH Grant/Contract )
KL2TR001429 ( U.S. NIH Grant/Contract )
OCR25582 ( Other Identifier: UF OnCore )
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection