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HIV InfectionsTMINCT03681912

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

An observational study of HIV Infections and Adolescent Development, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS), Randomized Guided Development of COPs with an internal facilitator after one year of implementation. and CoP development without internal facilitation.
How many people
188 participants
Where
1 siteUnited States
Study dates
28 Aug 2017to 31 Dec 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Providers of prevention and care for youth with HIV

Who may be able to join

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

Who cannot join

  • Non-providers of youth HIV prevention and care

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wayne State University

    Detroit, Michigan, 48202

Other trials in United States

About this study

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.

Read the 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).

Being tested
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS), Randomized Guided Development of COPs with an internal facilitator after one year of implementation., CoP development without internal facilitation.
Keywords
Implementation Science, Motivational Interviewing, Youth Living with HIV
Medical subject headings
HIV Infections, Patient Compliance, Treatment Refusal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.Behavioural

    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.Behavioural

    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

Study groups in NCT03681912
Study groupRoleWhat they receive
Implementation Block 1Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
Receives: Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)
Implementation Block 2Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 6 months.
Receives: Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)
Implementation Block 3Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 9 months.
Receives: Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)
Implementation Block 4Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 12 months.
Receives: Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)
Implementation Block 5Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 15 months.
Receives: Behavioral: Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)
Sustainment Block 1 Facilitated CoPRandomized Guided Development of COPs with an internal facilitator after one year of implementation.
Receives: Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.
Sustainment Block 2 Facilitated CoPRandomized Guided Development of COPs with an internal facilitator after one year of implementation.
Receives: Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.
Sustainment Block 3 Facilitated CoPRandomized Guided Development of COPs with an internal facilitator after one year of implementation.
Receives: Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.
Sustainment Block 4 Facilitated CoPRandomized Guided Development of COPs with an internal facilitator after one year of implementation.
Receives: Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.
Sustainment Block 5 Facilitated CoPRandomized Guided Development of CoPs with an internal facilitator after one year of implementation.
Receives: Behavioral: Randomized Guided Development of COPs with an internal facilitator after one year of implementation.
Sustainment Block 1 CoP AloneAfter one year of implementation, site is randomized to receive CoP development without internal facilitation.
Receives: Behavioral: CoP development without internal facilitation.
Sustainment Block 2 CoP AloneAfter one year of implementation, site is randomized to receive CoP development without internal facilitation.
Receives: Behavioral: CoP development without internal facilitation.
Sustainment Block 3 CoP AloneAfter one year of implementation, site is randomized to receive CoP development without internal facilitation.
Receives: Behavioral: CoP development without internal facilitation.
Sustainment Block 4 CoP AloneAfter one year of implementation, site is randomized to receive CoP development without internal facilitation.
Receives: Behavioral: CoP development without internal facilitation.
Sustainment Block 5 CoP AlongAfter one year of implementation, site is randomized to receive CoP development without internal facilitation.
Receives: Behavioral: CoP development without internal facilitation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Every three months over fifteen months

Secondary outcomes (1)
  1. Change in Individual Patients' Records Report Related to HIV Viral Load

    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 include viral load

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2018
  2. Study start28 Aug 2017
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03681912
Sponsor's protocol ID
ATN 146
Acronym
TMI
Status last verified
Dec 2024
First submitted
7 Sep 2018
Last updated
15 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • MacDonell KK, Simpson KN, Todd L, Hall AL, Naar S. Cost of implementing tailored motivational interviewing training in youth HIV clinics. BMC Health Serv Res. 2026 Apr 30;26(1):841. doi: 10.1186/s12913-026-14622-y.

    PubMed 42063152
  • 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.

    PubMed 36273221
  • 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.

    PubMed 31237839

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Adolescent Development, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Raw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) (time frame: Every three months over fifteen months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03681912, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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