Substance UseNCT03057119

Feasibility of SBIRT-PN

A study testing Psycho-educational content (5 Minutes), Readiness Assessment (10 minutes) and Goal-Setting (5 minutes) in people with Substance Use and HIV/AIDS, run by Florida State University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Substance Use, HIV/AIDS, Older Adults
What is being tested?: Psycho-educational content (5 Minutes), Readiness Assessment (10 minutes) and Goal-Setting (5 minutes)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 3 sitesUnited States
Study dates: 12 Feb 2018to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Florida
Gainesville, Florida, 32611
CAN Community Health
Jacksonville, Florida, 32207
Department of Health in Columbia County",
Lake City, Florida, 32055

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Substance Use, HIV/AIDS, Older Adults, Behavioral Intervention, Infectious Disease
Being tested: Psycho-educational content (5 Minutes), Readiness Assessment (10 minutes), Goal-Setting (5 minutes), Identifying and prioritizing needs (5 minutes), Explanation of Peer Navigator and Session wrap (5 minutes)
Medical subject headings: Substance-Related Disorders, Acquired Immunodeficiency Syndrome, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psycho-educational content (5 Minutes)Behavioural
The interventionist will discuss substance use and misuse and the influence of substance use on self care.
Readiness Assessment (10 minutes)Behavioural
Also called Prochaska's stages of change.
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)Behavioural
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)Behavioural
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)Behavioural
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.

Study groups in NCT03057119
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 Days

Secondary outcomes (3)

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
Measured: 6 Months
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.
Measured: 6 Months
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.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 201831 Mar 2022

First posted17 Feb 2017
Study start12 Feb 2018
Primary completion28 Feb 2021
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Substance UseStudies of the same condition, open and under way.
More trials run by Florida State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: A repeated measures randomized control trial design to compare patient outcomes at baseline as well as 3 and 6 months post-intervention
Masking: Single blind
Who is masked: Participant
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03057119
Sponsor's protocol ID: IRB201701252 - N
Other IDs: 1K23DA039769-01, KL2TR001429, OCR25582
Status last verified: Sep 2023
First submitted: 15 Feb 2017
Last updated: 11 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Screening, Brief Intervention, Referral to Treatment With Peer Navigation (SBIRT-PN) for Underserved HIV+ Adults 50+ in Primary Care Settings.
ClinicalTrials.gov ID: NCT03057119
Acronym / sponsor ID: IRB201701252 - N
Conditions: Substance Use, HIV/AIDS, Older Adults, Behavioral Intervention, Infectious Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), National Center for Advancing Translational Sciences (NCATS)
Study start: 12 Feb 2018 (actual)
Primary completion: 28 Feb 2021 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 17 Feb 2017 (actual)
Results: Posted 11 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In order to develop effective substance use intervention models for HIV care settings the specific aims of the current project are:

Aim2a: Assess the acceptability of SBIRT-PN. The investigators hypothesize that SBIRT-PN will demonstrate high acceptability among patients enrolled in this condition.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: A repeated measures randomized control trial design to compare patient outcomes at baseline as well as 3 and 6 months post-intervention

Arm	Type	Receives
SBIRT Intervention	Experimental	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)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.
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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psycho-educational content (5 Minutes)The interventionist will discuss substance use and misuse and the influence of substance use on self care.	Behavioural	SBIRT Intervention
Readiness Assessment (10 minutes)Also: Prochaska's stages of change.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.	Behavioural	SBIRT Intervention
Goal-Setting (5 minutes)The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.	Behavioural	SBIRT Intervention
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.	Behavioural	SBIRT Intervention
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.	Behavioural	SBIRT Intervention

Primary outcome

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.

3 secondary outcomes

Number of Participants Who Obtained Formal Substance Use Treatment
Time frame: 6 Months
Number of Participants Who Used Different Types of Substances (Self-Reported)
Time frame: 6 Months
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Time frame: 6 Months

Results and safety

Results posted to the registry on 11 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I: SBIRT Intervention (Pre-COVID-19)	17	4
Phase I: Treatment as Usual (Pre-COVID-19)	17	3
Phase II: CAN Pandemic Telesurvey (Post-COVID-19)	52	13

Primary outcome: Number of Participants Ranking Intervention as Acceptable

Time frame: 30 Days. Count of participants. Unit: Participants

Measure	Phase I: SBIRT Intervention (Pre-COVID-19) n = 9	Phase I: Treatment as Usual (Pre-COVID-19) n = 5	Phase II: CAN Pandemic Telesurvey (Post-COVID-19) n = 0
Value	9	5	–

Population analysed: CAN Pandemic Telesurvey arm of this study did not include an intervention or a peer navigation element, and therefore did not have include the acceptability measures as in Phase I.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected throughout the entire study data collection process (6 months for each participant). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I: SBIRT Intervention (Pre-COVID-19)	0 of 17 (0%)	0 of 17 (0%)	1 of 17
Phase I: Treatment as Usual (Pre-COVID-19)	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Phase II: CAN Pandemic Telesurvey (Post-COVID-19)	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicole Ennis, PHD principal investigator

Florida State University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Ranking Intervention as Acceptable (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03057119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.