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Completed

NCT Number: NCT03057119

Feasibility of SBIRT-PN

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.

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Key information

Conditions

Substance Use Acquired Immunodeficiency Syndrome Behavioral Intervention Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Disease Attributes Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Infectious Disease Lentivirus Infections Mental Disorders Older Adults Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psycho-educational content (5 Minutes)

Behavioral

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

Readiness Assessment (10 minutes)

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.

Other names: Prochaska's stages of change.

Goal-Setting (5 minutes)

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)

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)

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.

Primary outcomes

  1. Number of Participants Ranking Intervention as Acceptable

    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 outcomes

  1. Number of Participants Who Obtained Formal Substance Use Treatment

    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. Number of Participants Who Used Different Types of Substances (Self-Reported)

    Time frame: 6 Months

    A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used.

  3. Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2017
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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