Feasibility of SBIRT-PN

HIV/AIDS Clinical Trial

Official title:

Feasibility of Screening, Brief Intervention, Referral to Treatment With Peer Navigation (SBIRT-PN) for Underserved HIV+ Adults 50+ in Primary Care Settings.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057119
• Other study ID #: IRB201701252 - N
• Secondary ID: 1K23DA039769-01K
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 31, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Intervention
• Communicable Diseases
• HIV/AIDS
• Infections
• Infectious Disease
• Older Adults
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Psycho-educational content (5 Minutes)
The interventionist will discuss substance use and misuse and the influence of substance use on self care.
• 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.
• Goal-Setting (5 minutes)
The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	CAN Community Health	Jacksonville	Florida
United States	Department of Health in Columbia County",	Lake City	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 Days
Secondary	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	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months