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Feasibility of SBIRT-PN

Primary Purpose

Substance Use, HIV/AIDS, Older Adults

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psycho-educational content (5 Minutes)
Readiness Assessment (10 minutes)
Goal-Setting (5 minutes)
Identifying and prioritizing needs (5 minutes)
Explanation of Peer Navigator and Session wrap (5 minutes)
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Substance Use

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida
  • CAN Community Health
  • Department of Health in Columbia County",

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SBIRT Intervention

Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Ranking Intervention as Acceptable
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

Number of Participants Who Obtained Formal Substance Use Treatment
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
Number of Participants Who Used Different Types of Substances (Self-Reported)
A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used.
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
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.

Full Information

First Posted
February 15, 2017
Last Updated
September 7, 2023
Sponsor
Florida State University
Collaborators
National Institute on Drug Abuse (NIDA), National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03057119
Brief Title
Feasibility of SBIRT-PN
Official Title
Feasibility of Screening, Brief Intervention, Referral to Treatment With Peer Navigation (SBIRT-PN) for Underserved HIV+ Adults 50+ in Primary Care Settings.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute on Drug Abuse (NIDA), National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, HIV/AIDS, Older Adults, Behavioral Intervention, Infectious Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBIRT Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-educational content (5 Minutes)
Intervention Description
The interventionist will discuss substance use and misuse and the influence of substance use on self care.
Intervention Type
Behavioral
Intervention Name(s)
Readiness Assessment (10 minutes)
Other Intervention Name(s)
Prochaska's stages of change.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal-Setting (5 minutes)
Intervention Description
The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.
Intervention Type
Behavioral
Intervention Name(s)
Identifying and prioritizing needs (5 minutes)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Explanation of Peer Navigator and Session wrap (5 minutes)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Ranking Intervention as Acceptable
Description
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.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Number of Participants Who Obtained Formal Substance Use Treatment
Description
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
Time Frame
6 Months
Title
Number of Participants Who Used Different Types of Substances (Self-Reported)
Description
A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used.
Time Frame
6 Months
Title
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Ennis, PHD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
CAN Community Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Department of Health in Columbia County",
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of SBIRT-PN

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