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

HIV Infections Clinical Trial

— TMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681912
• Other study ID #: ATN 146
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The NIH Office of AIDS Research called for implementation science (IS) to address the behavioral research-practice gap.Motivational Interviewing (MI) is the only behavioral intervention to date shown to be effective to improve self-management for youth living with HIV (YLH). MI was also the only intervention to demonstrate success across the youth HIV care cascade. MI interventions can target multiple behaviors and be delivered by multiple provider-types as is common in adolescent HIV care settings. Finally, MI is already embedded in the clinical guidelines for HIV care and HIV risk reduction. Implementation Science is the scientific study of methods to promote the uptake of research findings and evidence-based practice (EBPs) to improve the quality of behavior change approaches in health care settings. A primary challenge of scaling up EBP's is the balance of flexibility (adaptation to context) and fidelity (provider adherence and competence). The Dynamic Adaptation Process (DAP) guides tailoring of MI implementation at the exploration, preparation, implementation, and sustainment phases (EPIS) of scale up. The goal of this proposal is to test a multi-faceted Tailored Motivational Interviewing, Implementation intervention (TMI), based on the DAP to scale up an EBP in multidisciplinary adolescent HIV care settings while balancing flexibility and fidelity. The pilot work for TMI included tailoring of initial workshop training based on innovative methods in communication science, developing efficient fidelity measurement, and pilot testing the revised intervention. The initial TMI workshop was adapted based on findings from sequential analysis of provider interactions with youth living with HIV (YLH) by emphasizing provider communication strategies most associated with patient motivational statements ("change talk"), de-emphasizing MI strategies that were unrelated to change talk, and suppressing those that were associated with a motivational statements ("counter-change talk"). Additional tailoring based on the DAP requires that qualitative and quantitative data are collected during the exploration phase. In the preparation phase, these data are reviewed by an implementation team comprised of local stakeholders and experts in MI implementation who recommend necessary adaptations for the service context while balancing the need for fidelity (adherence to minimum implementation requirements and achieving provider competency thresholds). In the implementation phase, ongoing fidelity monitoring determines the need for ongoing coaching, thus amount of coaching is tailored to the individual provider. Finally, the sustainment phase addresses the maintenance of innovation beyond 1 year utilizing strategies such as developing communities of practice (CoPs) and promoting internal facilitation of TMI. In a hybrid implementation-effectiveness (Type 3) trial, the effect of TMI will be tested on fidelity EBP, and secondarily on HIV cascade-related outcomes, using a dynamic wait-listed design (DWLD) 18 with 165 providers nested within 10 Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN4) sites. With this design, the 10 clinics will be randomly assigned in 5 clusters to receive TMI. For each randomization, 2 clinics receive TMI and the others remain in the wait-list condition. This will continue until the 5th cluster has been randomized to TMI. After one year of TMI's external facilitation based on the DAP, a second randomization will compare internal facilitator monitoring and coaching plus the encouragement of CoPs to CoPs alone. Fidelity will be assessed on a quarterly basis through the 24 months of intervention and an additional 6 months of follow-up. The proposal uses the EPIS model, to guide the investigation of the interacting elements that influence successful implementation. The qualitative method will be nested within the quantitative study to provide a deeper understanding of the implementation context and understand why or why not MI is integrated with fidelity across the 150 providers. Providers and key stakeholders will complete qualitative interviews and brief assessments based on EPIS at baseline, after one year of TMI (first randomization), and after 1 year of follow-up (second randomization).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-providers of youth HIV prevention and care

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)
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.
• Randomized Guided Development of COPs with an internal facilitator after one year of implementation.
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.
• CoP development without internal facilitation.
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

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (13)

Lead Sponsor

Collaborator

Florida State University

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Competency "Avg of CRS Score": 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.; 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.	Three months following initial training completion; Three months after each previous measurement throughout study.
Secondary	Change in individual patients' records report related to HIV Cascade Variables "Any reported variance irrespective of measurement used".	Record/chart abstraction conducted for patients in care at the site for; The 12 months prior to the start of implementation; The 12 months during implementation; and; The 6 months after the end of the implementation intervention.; These data may include any of the following: prescription adherence, cluster of differentiation 4 - T helper cell glycoprotein (CD4) counts, viral load, appointment adherence, number of youth receiving services from site plus number of new diagnoses ID'd & linked to care, the date of diagnosis and care entry, along with all variables assessed.	12 months prior to start; The end of the 12 month intervention, and 6 months after end of implementation interview