Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 11:48 PM
Study NCT ID:
NCT03681912
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings
Sponsor:
Florida State University
Organization:
Study Overview
Official Title:
Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMI
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.
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.
Detailed 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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: