NCT02495402

Brief Summary

To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
827

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

39 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 6, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

July 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

July 6, 2015

Last Update Submit

May 7, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Days of Primary Substance Use

    Days of Primary Substance Use - A continuous measure (ranges from 0 - 28) that is based on a question that asks participants to report how many days during the past 28 days they used their primary substance.

    4 weeks post randomization

  • Number of Substance-related problems

    Number of Substance-related problems - A continuous measure (ranges from 0 - 11) that represents the sum of the number of 11 DSM-V substance use disorder symptoms participants report having occured during the past 28 days.

    4 weeks post randomization

  • Times engaging in risky behaviors

    Times engaging in risky behaviors - A continuous measure (no specified range) that is based on a question that asks participants to report how many times during the past 28 days they engaged in unprotected sex, IV drug use, or needle sharing.

    4 weeks post randomization

  • Days of Substance Use Treatment

    Days of Substance Use Treatment - A continuous measure (no specified range) that represents the sum of the number of days participants report going to residential treatment, outpatient treatment, or self-help group meetings during the past 28 days.

    4 weeks post randomization

  • ART Medication Adherence

    ART Medication Adherence - A continuous measure (ranges from 0 -28) that is based on a question that asks participants to report how many days during the past 28 days that they have missed at least one dose of their HIV medications.

    4 weeks post randomization

Secondary Outcomes (4)

  • Urgency to Change

    4 weeks post randomization

  • Intentions to Change

    4 weeks post randomization

  • Commitment to Change

    4 weeks post randomization

  • Self-Efficacy to Change

    4 weeks post randomization

Study Arms (2)

No Intervention: Control

NO INTERVENTION

No Intervention

Motivational Interviewing

EXPERIMENTAL

A brief interview intervention for substance abuse

Behavioral: Motivational Interviewing

Interventions

Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.

Motivational Interviewing

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have HIV/AIDS.
  • Be 18 years of age or older.
  • Acknowledges use of at least one substance within the past 28 days and endorse 2+ substance use disorder symptoms during the past 12-months.
  • Provide signed and dated assurance of consent.

You may not qualify if:

  • Are unable to speak English.
  • Are unwilling to allow brief intervention sessions to be audio recorded.
  • Are unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

HIV Care Directions

Phoenix, Arizona, 85014, United States

Location

Foothill AIDS Project

Claremont, California, 91711, United States

Location

AIDS Services Foundation, Orange County

Irvine, California, 92614, United States

Location

AIDS Project Los Angeles

Los Angeles, California, 90005, United States

Location

Shanti

San Francisco, California, 94109, United States

Location

AIDS Project Greater Danbury, Inc.

Danbury, Connecticut, 06810, United States

Location

AIDS Connecticut, Inc

Hartford, Connecticut, 06106, United States

Location

Delaware HIV Consortium

Wilmington, Delaware, 19801, United States

Location

The Women's Collective

Washington D.C., District of Columbia, 20020, United States

Location

Project Response, Inc.

Melbourne, Florida, 32901, United States

Location

Live Forward (AIDS Athens)

Athens, Georgia, 30601, United States

Location

Champaign-Urbana Public Health District (Collaborating Organization)

Champaign, Illinois, 61820, United States

Location

The Project of the Quad Cities (Collaborating Organization)

Davenport, Iowa, 52808, United States

Location

AIDS Volunteers, Inc. (AVOL)

Lexington, Kentucky, 40504, United States

Location

Southwest Louisiana AIDS Council

Lake Charles, Louisiana, 70601, United States

Location

AIDS Project Worcester

Worcester, Massachusetts, 01604, United States

Location

Health Emergency Lifeline Programs (Collaborating Organization)

Detroit, Michigan, 48216, United States

Location

Community Health Awareness Group (Collaborating Organization)

Detroit, Michigan, 48226, United States

Location

Community AIDS Resources and Education Services (Collaborating Organization)

Kalamazoo, Michigan, 49008, United States

Location

Minnesota AIDS Project (Collaborating Organization)

Minneapolis, Minnesota, 55404, United States

Location

Burrell Behavioral Health (Collaborating Organization)

Springfield, Missouri, 65804, United States

Location

Doorways (Collaborating Organization)

St Louis, Missouri, 63108, United States

Location

Places for People (Collaborating Organization)

St Louis, Missouri, 63108, United States

Location

Project ARK

St Louis, Missouri, 63110, United States

Location

St. Louis Effort for AIDS (Collaborating Organization)

St Louis, Missouri, 63110, United States

Location

Nebraska AIDS Project (Collaborating Organization )

Omaha, Nebraska, 68114, United States

Location

Southern NH HIV/AIDS Task Force

Nashua, New Hampshire, 03060, United States

Location

Caracole House (Collaborating Organization)

Cincinnati, Ohio, 45223, United States

Location

ARC Ohio (Collaborating Organization)

Columbus, Ohio, 43214, United States

Location

HIV Alliance

Eugene, Oregon, 97403, United States

Location

AID Upstate

Greenville, South Carolina, 29601, United States

Location

Chattanooga CARES

Chattanooga, Tennessee, 37403, United States

Location

Nashville CARES

Nashville, Tennessee, 37204, United States

Location

Panhandle AIDS Support Organization

Amarillo, Texas, 79101, United States

Location

Triangle Area Network

Beaumont, Texas, 77702, United States

Location

AIDS Foundation Houston

Houston, Texas, 77057, United States

Location

Alamo Area Resource Center

San Antonio, Texas, 78207, United States

Location

Utah AIDS Foundation

Salt Lake City, Utah, 84105, United States

Location

Vermont CARES

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

  • Ford JH 2nd, Gilson AM, Maurer MA, Hoffman KA, Garner BR. A peek behind the curtain: exploring coaching styles within the implementation and sustainment facilitation (ISF) strategy in the substance abuse treatment to HIV care study. Implement Sci Commun. 2021 Dec 20;2(1):140. doi: 10.1186/s43058-021-00246-2.

  • Garner BR, Gotham HJ, Tueller SJ, Ball EL, Kaiser D, Stilen P, Speck K, Vandersloot D, Rieckmann TR, Chaple M, Martin EG, Martino S. Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial. Addict Sci Clin Pract. 2017 Nov 17;12(1):31. doi: 10.1186/s13722-017-0095-8.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bryan R Garner, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 13, 2015

Study Start

July 8, 2015

Primary Completion

December 28, 2017

Study Completion

March 25, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations