NCT03181022

Brief Summary

The purpose of the Tailored Motivational Interviewing Project (TMI) is to develop an implementation intervention to increase evidence-based patient-provider communication strategies using a Motivational Interviewing (MI) framework.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

December 8, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

4.9 years

First QC Date

May 25, 2017

Last Update Submit

April 7, 2021

Conditions

Keywords

Patient-Provider CommunicationMotivational InterviewingMedication Adherence

Outcome Measures

Primary Outcomes (1)

  • MI Coach Rating Scale

    Fidelity to Motivational Interviewing by HIV care providers

    Change from pre- to post-training and implementation (12 months)

Study Arms (4)

Phase 1a

NO INTERVENTION

To develop a measure of MI fidelity to ensure methodological rigor, acceptability and feasibility of administration, and clinical usefulness (Phase 1a). Ratings of 200 recordings of full patient-provider interactions with ratings of thin slices (recording 1 minute every 5 minutes) will be compared.

Phase 1b

NO INTERVENTION

To conduct evidence-based tailoring of MI training for adolescent HIV care settings (Phase 1b). Coding via sequential analysis will be conducted of the 200 recordings to identify those specific provider communication behaviors that predict subsequent youth motivational statements.

Phase 2

NO INTERVENTION

To collaboratively develop the implementation intervention with 2 clinic teams associated with the ATN (Phase 2). A formative evaluation will be done to provide local diagnostic data regarding barriers and facilitators to adoption and create development panels - local development teams made up of clinicians and administrators from the site, and study staff to address barriers and facilitators from formative evaluation and draft locally-customized clinical care and multi-level implementation strategies with initial sustainability plans.

Phase 3

EXPERIMENTAL

To pilot test the implementation intervention and process/outcome evaluation protocols at two ATN sites in preparation for a full-scale trial.

Behavioral: Motivational Interviewing

Interventions

HIV care providers will be asked to attend an MI training workshop lasting a total of 12 hours. The workshop will be conducted by members of the MI Network of Trainers. MI training relies on experiential activities and cooperative learning methods. After the training, study staff will monitor MI fidelity, or how providers are using the MI skills, using the MI Coach Rating Scale. This will occur 3 times prior to the training, 3 times during the practice period, and then quarterly. They will be asked to complete an audiotaped standardized patient interaction (approximately 30 minutes) with one of the study staff. These will be coded and providers will be informed of their competency level for all but the pre-training role plays. Coaching will be provided for all participants during the practice period. For the quarterly role plays, no coaching occurs unless their score indicates they need additional coaching (an additional 45 minute session with an MI trainer).

Phase 3

Eligibility Criteria

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

You may qualify if:

  • Patients: HIV+, current patient in HIV adolescent care clinic
  • Providers: Provider in HIV adolescent care clinic

You may not qualify if:

  • Unable to consent to participate (lack of English fluency)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Center

Detroit, Michigan, 48201, United States

Location

Adolescent AIDS Program

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 8, 2017

Study Start

December 8, 2015

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations