Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings

NCT03681912 | Completed Results DMC

• 1 other identifier: ATN 146
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test a multi-faceted Tailored Motivational Interviewing Implementation intervention (TMI), based on the Dynamic Adaptation Process (DAP) to scale up an Evidence-based Practice (EBP) in multidisciplinary adolescent HIV care settings while balancing flexibility and fidelity. A mixed-methods design will be used, in which the dominant method is quantitative (a dynamic wait-listed design; DWLD) to determine the impact of TMI on the integration of MI with fidelity in 10 adolescent HIV clinics with an average of 15 providers and 100 patients each.

Conditions

HIV Infections; Adolescent Development; Care Eliciting Behavior; Patient Non-Compliance; Patient Refusal of Treatment

Keywords

Implementation Science; Motivational Interviewing; Youth Living with HIV

Outcome Measures

Primary Outcomes (1)

• Raw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)

  Providers will complete a 15-minute standard patient role-play at each point during baseline, implementation and sustainment. The Research Assistant (RA) will code these interactions on the 12-item MI CRS and reliability will continue to be monitored with one coding per month co-coded by Dr. Naar. These reports will be cumulatively reported and collected quarterly. Each item on the CRS has a score of 1 (lowest) to 4 (highest). The 12 scores are added and averaged for a score that reflects competency: \<2.0=Beginner. \>=2.0 to \<2.6. \>=2.6 to \<3.3=Intermediate. \>=3.3=Advanced. The outcomes provided below represent the average of the provider scores and reported by site and implementation phase. For sites randomized to internal facilitation in the sustainment period, the RA will code the same interactions so that the facilitator ratings will not be used for research purposes.

  Every three months over fifteen months

Secondary Outcomes (1)

• Change in Individual Patients' Records Report Related to HIV Viral Load

  12 months prior to start; The end of the 12 month intervention, and 6 months after end of implementation interview

Study Arms (15)

Implementation Block 1

Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.

Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)

Implementation Block 2

Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 6 months.

Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)

Implementation Block 3

Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 9 months.

Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)

Implementation Block 4

Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 12 months.

Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)

Implementation Block 5

Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 15 months.

Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)

Sustainment Block 1 Facilitated CoP

Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Sustainment Block 2 Facilitated CoP

Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Sustainment Block 3 Facilitated CoP

Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Sustainment Block 4 Facilitated CoP

Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Sustainment Block 5 Facilitated CoP

Randomized Guided Development of CoPs with an internal facilitator after one year of implementation.

Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.

Sustainment Block 1 CoP Alone

After one year of implementation, site is randomized to receive CoP development without internal facilitation.

Behavioral: CoP development without internal facilitation.

Sustainment Block 2 CoP Alone

After one year of implementation, site is randomized to receive CoP development without internal facilitation.

Behavioral: CoP development without internal facilitation.

Sustainment Block 3 CoP Alone

After one year of implementation, site is randomized to receive CoP development without internal facilitation.

Behavioral: CoP development without internal facilitation.

Sustainment Block 4 CoP Alone

After one year of implementation, site is randomized to receive CoP development without internal facilitation.

Behavioral: CoP development without internal facilitation.

Sustainment Block 5 CoP Along

After one year of implementation, site is randomized to receive CoP development without internal facilitation.

Behavioral: CoP development without internal facilitation.

Interventions

Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) BEHAVIORAL

Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator. Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence.

Implementation Block 1; Implementation Block 2; Implementation Block 3; Implementation Block 4; Implementation Block 5

Randomized Guided Development of COPs with an internal facilitator after one year of implementation. BEHAVIORAL

Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency.

Sustainment Block 1 Facilitated CoP; Sustainment Block 2 Facilitated CoP; Sustainment Block 3 Facilitated CoP; Sustainment Block 4 Facilitated CoP; Sustainment Block 5 Facilitated CoP

CoP development without internal facilitation. BEHAVIORAL

Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity

Sustainment Block 1 CoP Alone; Sustainment Block 2 CoP Alone; Sustainment Block 3 CoP Alone; Sustainment Block 4 CoP Alone; Sustainment Block 5 CoP Along

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Providers of prevention and care for youth with HIV

You may qualify if:

• All youth HIV providers (prevention and care) at our target clinics will be eligible to participate.

You may not qualify if:

• Non-providers of youth HIV prevention and care

Sponsors & Collaborators

• Florida State University: lead
• St. Jude Children's Research Hospital: collaborator
• Children's Hospital of Philadelphia: collaborator
• State University of New York: collaborator
• University of Miami: collaborator
• Johns Hopkins University: collaborator
• University of California, San Diego: collaborator
• University of Alabama at Birmingham: collaborator
• University of South Florida: collaborator
• Children's Hospital Los Angeles: collaborator
• Children's National Research Institute: collaborator
• City University of New York, School of Public Health: collaborator
• Wayne State University: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

• Coyle K, Carcone AI, Butame S, Pooler-Burgess M, Chang J, Naar S. Adapting the self-assessment of contextual fit scale for implementation of evidence-based practices in adolescent HIV settings. Implement Sci Commun. 2022 Oct 22;3(1):115. doi: 10.1186/s43058-022-00349-4.

  PMID: 36273221 DERIVED

• Naar S, MacDonell K, Chapman JE, Todd L, Gurung S, Cain D, Dilones RE, Parsons JT. Testing a Motivational Interviewing Implementation Intervention in Adolescent HIV Clinics: Protocol for a Type 3, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019 Jun 7;8(6):e11200. doi: 10.2196/11200.

  PMID: 31237839 DERIVED

MeSH Terms

Conditions

HIV Infections; Patient Compliance; Treatment Refusal

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Sylvie Naar, PhD; Distinguished Endowed Professor
• Organization: Florida State University

sylvie.naar@med.fsu.edu

850-644-2334

Study Officials

• Lisa Todd, MS, JD

  Wayne State University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 24, 2018
• Study Start: August 28, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-12

Locations

US (1)