NCT03057119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 11, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

February 15, 2017

Results QC Date

March 20, 2023

Last Update Submit

September 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Participants Who Obtained Formal Substance Use Treatment

    6 Months

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

    6 Months

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

    6 Months

Study Arms (2)

SBIRT Intervention

EXPERIMENTAL

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)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)

Treatment as Usual

NO INTERVENTION

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.

Interventions

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

SBIRT Intervention

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.

Also known as: Prochaska's stages of change.
SBIRT Intervention

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

SBIRT Intervention

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.

SBIRT Intervention

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.

SBIRT Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Florida

Gainesville, Florida, 32611, United States

Location

CAN Community Health

Jacksonville, Florida, 32207, United States

Location

Department of Health in Columbia County",

Lake City, Florida, 32055, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersAcquired Immunodeficiency SyndromeCommunicable Diseases

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHIV InfectionsBlood-Borne InfectionsInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

In March 2020, the COVID-19 pandemic made in-person assessments as described in Phase I (SBIRT-PN \& TAU), particularly involving vulnerable populations such as PLWH and older adults, impossible. Recommendations for social distancing/self-isolation remained in place for extended periods of time. Data was needed regarding the impact of the pandemic, both physically and emotionally, on PLWH. We gathered this data within a specialized HIV care setting in order to optimize health outcomes (Phase II).

Results Point of Contact

Title
Katie Kloss
Organization
Florida State University

Study Officials

  • Nicole Ennis, PHD

    Florida State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: A repeated measures randomized control trial design to compare patient outcomes at baseline as well as 3 and 6 months post-intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 17, 2017

Study Start

February 12, 2018

Primary Completion

February 28, 2021

Study Completion

March 31, 2022

Last Updated

September 11, 2023

Results First Posted

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations