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NCT03681912: TMI

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

Completed Results posted Last updated 15 January 2025
What this trial tests

trial testing Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) in HIV Infections in 188 participants. Completed in 31 December 2021.

Timeline
28 August 2017
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorFlorida State University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment188
Start date28 August 2017
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Florida State University

Who can join

Adults 18 to 65, any sex, with HIV Infections or Adolescent Development. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Raw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) Primary · Every three months over fifteen months

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

Implementation Phase
GroupValue95% CI
Block 1 Site 7 - CoP Alone2.72± 0.45
Block 1 Site 10 - CoP Facilitated2.50± 0.46
Block 2 Site 3 - CoP Facilitated1.99± 0.34
Block 2 Site 8 - CoP Alone2.32± 0.51
Block 3 Site 1 - CoP Facilitated2.47± 0.53
Block 3 Site 11 - CoP Alone2.91± 0.37
Block 4 Site 2 - CoP Facilitated2.62± 0.50
Block 4 Site 12 - CoP Alone2.39± 0.43
Block 5 Site 6 - CoP Alone2.63± 0.49
Block 5 Site 13 - CoP Facilitated2.66± 0.48
Sustainment Phase
GroupValue95% CI
Block 1 Site 7 - CoP Alone2.78± 0.43
Block 1 Site 10 - CoP Facilitated2.59± 0.26
Block 2 Site 3 - CoP Facilitated2.19± 0.37
Block 2 Site 8 - CoP Alone2.19± 0.26
Block 3 Site 1 - CoP Facilitated2.38± 0.56
Block 3 Site 11 - CoP Alone2.82± 0.43
Block 4 Site 2 - CoP Facilitated2.73± 0.51
Block 4 Site 12 - CoP Alone2.41± 0.48
Block 5 Site 6 - CoP Alone2.76± 0.61
Block 5 Site 13 - CoP Facilitated2.65± 0.45
Change in Individual Patients' Records Report Related to HIV Viral Load Secondary · 12 months prior to start; The end of the 12 month intervention, and 6 months after end of implementation interview

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

Baseline Phase - 12 months prior to the start of implementation
GroupValue95% CI
Block 1 Site 71.88± 0.80
Block 1 Site 102.43± 1.04
Block 2 Site 32.29± 1.05
Block 2 Site 82.28± 1.12
Block 3 Site 12.30± 1.17
Block 3 Site 112.20± 0.99
Block 4 Site 22.36± 1.25
Block 4 Site 122.35± 1.20
Block 5 Site 61.92± 1.70
Block 5 Site 131.11± 2.89
Implementation Phase - 12 months during implementation
GroupValue95% CI
Block 1 Site 71.85± 0.86
Block 1 Site 101.81± 0.61
Block 2 Site 32.12± 1.25
Block 2 Site 81.89± 0.97
Block 3 Site 12.00± 1.07
Block 3 Site 112.07± 1.09
Block 4 Site 22.12± 1.27
Block 4 Site 122.10± 1.21
Block 5 Site 61.78± 1.49
Block 5 Site 132.38± 1.25
Sustainment Phase - 6 months after the end of the implementation
GroupValue95% CI
Block 1 Site 71.88± 0.83
Block 1 Site 101.80± 0.59
Block 2 Site 32.31± 1.23
Block 2 Site 82.00± 1.10
Block 3 Site 11.98± 1.08
Block 3 Site 111.90± 0.77
Block 4 Site 22.22± 1.19
Block 4 Site 121.76± 0.87
Block 5 Site 61.79± 0.77
Block 5 Site 132.17± 1.15

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Testing a Motivational Interviewing Implementation Intervention in Adolescent HIV Clinics: Protocol for a Type 3, Hybrid Implementation-Effectiveness Trial.
    Naar S, MacDonell K, Chapman JE, Todd L, et al · · 2019 · cited 21× · PMID 31237839 · DOI 10.2196/11200
  2. Adapting the self-assessment of contextual fit scale for implementation of evidence-based practices in adolescent HIV settings.
    Coyle K, Carcone AI, Butame S, Pooler-Burgess M, et al · · 2022 · cited 4× · PMID 36273221 · DOI 10.1186/s43058-022-00349-4
  3. Cost of implementing tailored motivational interviewing training in youth HIV clinics.
    MacDonell KK, Simpson KN, Todd L, Hall AL, et al · · 2026 · PMID 42063152 · DOI 10.1186/s12913-026-14622-y

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03681912.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing