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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|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|
|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|
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.
- 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.
- 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
- 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.
- 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.
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
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|Department of Health in Columbia County",|
|Lake City, Florida, United States, 32055|
|Principal Investigator:||Nicole Ennis, PHD||Florida State University|