Feasibility of SBIRT-PN

NCT ID: NCT03057119

Last Updated: 2023-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Substance Use HIV/AIDS Older Adults Behavioral Intervention Infectious Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A repeated measures randomized control trial design to compare patient outcomes at baseline as well as 3 and 6 months post-intervention
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Psycho-educational content (5 Minutes)

Intervention Type BEHAVIORAL

The interventionist will discuss substance use and misuse and the influence of substance use on self care.

Readiness Assessment (10 minutes)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psycho-educational content (5 Minutes)

The interventionist will discuss substance use and misuse and the influence of substance use on self care.

Intervention Type 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.

Intervention Type BEHAVIORAL

Goal-Setting (5 minutes)

The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Prochaska's stages of change.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Nicole Ennis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Ennis, PHD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

CAN Community Health

Jacksonville, Florida, United States

Site Status

Department of Health in Columbia County",

Lake City, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K23DA039769-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KL2TR001429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR25582

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201701252 - N

Identifier Type: -

Identifier Source: org_study_id

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