NCT05609344

Brief Summary

Unhealthy drinking is considered one of the top 10 public health concerns in the United States. Not only has heavy drinking been linked to poorer overall health and the chances of getting cancer and cardiovascular diseases, but it also causes about 88,000 deaths and 2.5 million years of potential life lost each year in the U.S. Men living in rural areas tend to drink more. In Arkansas, a rural state with high rates of unhealthy drinking, men are more likely to report heavy drinking (4 or more drinks a day) and to drink more when binge drinking. Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based, multilevel, integrated public health approach for early intervention and timely referral to more intensive treatment for those with substance use disorders. SBIRTs have been successfully used in primary care and emergency settings. However, men in rural areas may lack access to evidence-based care for unhealthy drinking due to many factors, including limited healthcare providers and insurance standing. Given the increased chances of death and illness linked to harmful drinking among rural men and the serious health consequences involved, it is urgent to improve access to evidence-based care. This can be achieved by expanding services into community settings that men in rural areas are more likely to visit, such as barbershops. Thus, the goals of this proposed Hybrid Type 2 pragmatic effectiveness-implementation trial are to: 1) test the effectiveness of an evidence-based SBIRT intervention for use within barbershops (Barbershop Talk); and 2) generate the scientific evidence needed to implement SBIRTs in "real world" settings. Data from this study will further our understanding of how to reduce the chances of experiencing alcohol attributable morbidity and mortality among men living in rural areas. Data will also enhance our understanding of strategies that can improve the implementation of evidence-based care models in non-clinical settings, thereby extending the reach of evidence-based care to rural communities with high needs.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
611

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Jul 2027

First Submitted

Initial submission to the registry

October 17, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

October 17, 2022

Last Update Submit

March 13, 2026

Conditions

Drinking BehaviorDrinking ExcessiveDrinking

Outcome Measures

Primary Outcomes (18)

  • Alcohol Use - total number of drinking days

    At-risk drinking behavior measured as: number of drinking days

    Baseline

  • Alcohol Use - total number of drinking days

    At-risk drinking behavior measured as: number of drinking days

    3 months

  • Alcohol Use - total number of drinking days

    At-risk drinking behavior measured as: number of drinking days

    6 months

  • Alcohol Use - number of unhealthy drinking days

    At-risk drinking behavior measured as: number of unhealthy drinking days

    Baseline

  • Alcohol Use - number of unhealthy drinking days

    At-risk drinking behavior measured as: number of unhealthy drinking days

    3 months

  • Alcohol Use - total number of unhealthy drinking days

    At-risk drinking behavior measured as: number of unhealthy drinking days

    6 months

  • Mental Health - depression

    The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.

    Baseline

  • Mental Health - depression

    The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.

    3 months

  • Mental Health - depression

    The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.

    6 months

  • Mental Health - Posttraumatic Stress Disorder (PTSD)

    Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)

    Baseline

  • Mental Health - Posttraumatic Stress Disorder (PTSD)

    Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)

    3 months

  • Mental Health - Posttraumatic Stress Disorder (PTSD)

    Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)

    6 months

  • Social Support

    Family, friend, and partner support (number of people in support network)

    Baseline

  • Social Support

    Family, friend, and partner support (number of people in support network)

    3 months

  • Social Support

    Family, friend, and partner support (number of people in support network)

    6 months

  • Healthcare Utilization

    Number of subjects who have utilized healthcare services

    Baseline

  • Healthcare Utilization

    Number of subjects who have utilized healthcare services

    3 months

  • Healthcare Utilization

    Number of subjects who have utilized healthcare services

    6 months

Study Arms (2)

SBIRT

EXPERIMENTAL

Each intervention barbershop, will hold screening days, where a trained community health worker will be onsite to provide Screening, Brief Intervention, and Referral to Treatment (SBIRT).

Behavioral: SBIRT

Usual-care

OTHER

Six months after completion of Time 1, barbershops in the usual-care arm will receive the intervention.

Behavioral: SBIRT

Interventions

SBIRTBEHAVIORAL

Low risk individuals will receive an educational pamphlet about alcohol use and the impact on health. Moderate Risk individuals will receive a brief alcohol intervention. High risk individuals will receive the brief alcohol intervention and be referred to specialty treatment.

SBIRTUsual-care

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • aged 18 or older
  • resident of Arkansas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAMS

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Drinking Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tiffany F Haynes, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 8, 2022

Study Start

June 26, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

US(1)