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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03681912
Acronym
TMI
Enrollment
188
Registered
2018-09-24
Start date
2017-08-28
Completion date
2021-12-31
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Implementation Science, Motivational Interviewing, Youth Living with HIV

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.

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).

Interventions

BEHAVIORALCompetency: 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.

BEHAVIORALRandomized 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.

BEHAVIORALCoP 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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Raw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Every three months over fifteen monthsProviders 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.

Secondary

MeasureTime frameDescription
Change in Individual Patients' Records Report Related to HIV Viral Load12 months prior to start; The end of the 12 month intervention, and 6 months after end of implementation interviewRecord/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

Countries

United States

Participant flow

Recruitment details

TMI study staff will work with the SC at each site to introduce the project and recruit participants by scheduling and conducting introductory meetings. After the introductory meetings, the SC or PI from each site will send contact information (email, phone number) to the TMI study staff. The TMI study staff will contact participants via email and/or phone call to provide the information sheet and schedule of assessments.

Participants by arm

ArmCount
Block 1 Site 7
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
18
Block 1 Site 10
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
11
Block 2 Site 3
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
18
Block 2 Site 8
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
16
Block 3 Site 1
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
17
Block 3 Site 11
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
15
Block 4 Site 2
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
19
Block 4 Site 12
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
24
Block 5 Site 6
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
28
Block 5 Site 13
Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months.
22
Total188

Baseline characteristics

CharacteristicBlock 1 Site 10Block 2 Site 3Block 2 Site 8Block 3 Site 1Block 3 Site 11Block 4 Site 2Block 1 Site 7Block 4 Site 12Block 5 Site 6Block 5 Site 13Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants18 Participants16 Participants17 Participants15 Participants19 Participants18 Participants24 Participants28 Participants22 Participants188 Participants
Motivational Interviewing (MI) Coach Rating Scale (CRS) Criterion Score1.50 Units on a scale
STANDARD_DEVIATION 0.5
1.28 Units on a scale
STANDARD_DEVIATION 0.34
1.33 Units on a scale
STANDARD_DEVIATION 0.47
1.39 Units on a scale
STANDARD_DEVIATION 0.52
2.06 Units on a scale
STANDARD_DEVIATION 0.66
1.63 Units on a scale
STANDARD_DEVIATION 0.69
1.89 Units on a scale
STANDARD_DEVIATION 0.68
1.33 Units on a scale
STANDARD_DEVIATION 0.48
1.46 Units on a scale
STANDARD_DEVIATION 0.52
1.58 Units on a scale
STANDARD_DEVIATION 0.52
1.53 Units on a scale
STANDARD_DEVIATION 0.58
Motivational Interviewing (MI) Coach Rating Scale (CRS) (Raw Average)1.99 Units on a scale
STANDARD_DEVIATION 0.24
1.77 Units on a scale
STANDARD_DEVIATION 0.26
1.80 Units on a scale
STANDARD_DEVIATION 0.36
1.92 Units on a scale
STANDARD_DEVIATION 0.34
2.36 Units on a scale
STANDARD_DEVIATION 0.41
1.98 Units on a scale
STANDARD_DEVIATION 0.42
2.21 Units on a scale
STANDARD_DEVIATION 0.44
1.77 Units on a scale
STANDARD_DEVIATION 0.32
1.92 Units on a scale
STANDARD_DEVIATION 0.35
2.03 Units on a scale
STANDARD_DEVIATION 0.36
1.96 Units on a scale
STANDARD_DEVIATION 0.39
Race and Ethnicity Not Collected0 Participants
Race/Ethnicity, Customized
Asian
1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Black / African American
1 Participants3 Participants6 Participants6 Participants4 Participants7 Participants9 Participants3 Participants8 Participants4 Participants51 Participants
Race/Ethnicity, Customized
Hispanic
5 Participants6 Participants2 Participants0 Participants1 Participants0 Participants0 Participants4 Participants0 Participants1 Participants19 Participants
Race/Ethnicity, Customized
Middle Eastern / North African
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Not Hispanic
5 Participants10 Participants11 Participants10 Participants12 Participants14 Participants17 Participants5 Participants10 Participants6 Participants100 Participants
Race/Ethnicity, Customized
Other
1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants6 Participants
Race/Ethnicity, Customized
Uknown Hispanic
1 Participants2 Participants3 Participants7 Participants2 Participants5 Participants1 Participants15 Participants18 Participants15 Participants69 Participants
Race/Ethnicity, Customized
Unknown
1 Participants2 Participants3 Participants7 Participants2 Participants5 Participants1 Participants15 Participants18 Participants15 Participants69 Participants
Race/Ethnicity, Customized
White
7 Participants12 Participants5 Participants4 Participants9 Participants7 Participants7 Participants3 Participants2 Participants2 Participants58 Participants
Sex/Gender, Customized
Female
2 Participants2 Participants2 Participants1 Participants2 Participants1 Participants0 Participants3 Participants4 Participants0 Participants17 Participants
Sex/Gender, Customized
Male
8 Participants14 Participants11 Participants9 Participants9 Participants12 Participants17 Participants5 Participants6 Participants7 Participants98 Participants
Sex/Gender, Customized
Unknown
1 Participants2 Participants3 Participants7 Participants4 Participants6 Participants1 Participants16 Participants18 Participants15 Participants73 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

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.

Time frame: Every three months over fifteen months

Population: Participants may choose to leave the study at any point. Participants may be removed from the study based on changes in their clinical role and if they have less than 4 hours of client contact per week on average. Participant data will be included, unless a participant requests that their data is removed. In such cases, the participant's data will be deleted.

ArmMeasureGroupValue (MEAN)Dispersion
Block 1 Site 7 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.78 Units on a scaleStandard Deviation 0.43
Block 1 Site 7 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.72 Units on a scaleStandard Deviation 0.45
Block 1 Site 10 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.50 Units on a scaleStandard Deviation 0.46
Block 1 Site 10 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.59 Units on a scaleStandard Deviation 0.26
Block 2 Site 3 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase1.99 Units on a scaleStandard Deviation 0.34
Block 2 Site 3 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.19 Units on a scaleStandard Deviation 0.37
Block 2 Site 8 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.32 Units on a scaleStandard Deviation 0.51
Block 2 Site 8 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.19 Units on a scaleStandard Deviation 0.26
Block 3 Site 1 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.38 Units on a scaleStandard Deviation 0.56
Block 3 Site 1 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.47 Units on a scaleStandard Deviation 0.53
Block 3 Site 11 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.82 Units on a scaleStandard Deviation 0.43
Block 3 Site 11 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.91 Units on a scaleStandard Deviation 0.37
Block 4 Site 2 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.73 Units on a scaleStandard Deviation 0.51
Block 4 Site 2 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.62 Units on a scaleStandard Deviation 0.5
Block 4 Site 12 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.41 Units on a scaleStandard Deviation 0.48
Block 4 Site 12 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.39 Units on a scaleStandard Deviation 0.43
Block 5 Site 6 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.63 Units on a scaleStandard Deviation 0.49
Block 5 Site 6 - CoP AloneRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.76 Units on a scaleStandard Deviation 0.61
Block 5 Site 13 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Implementation Phase2.66 Units on a scaleStandard Deviation 0.48
Block 5 Site 13 - CoP FacilitatedRaw Average: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)Sustainment Phase2.65 Units on a scaleStandard Deviation 0.45
Secondary

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

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

Population: Record/Chart Abstraction was conducted based on number of patients at clinic for a given year. Clinic patient population numbers fluctuate.

ArmMeasureGroupValue (MEAN)Dispersion
Block 1 Site 7 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation1.88 Log of copies/mLStandard Deviation 0.8
Block 1 Site 7 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation1.85 Log of copies/mLStandard Deviation 0.86
Block 1 Site 7 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation1.88 Log of copies/mLStandard Deviation 0.83
Block 1 Site 10 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation1.80 Log of copies/mLStandard Deviation 0.59
Block 1 Site 10 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation1.81 Log of copies/mLStandard Deviation 0.61
Block 1 Site 10 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.43 Log of copies/mLStandard Deviation 1.04
Block 2 Site 3 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation2.31 Log of copies/mLStandard Deviation 1.23
Block 2 Site 3 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.29 Log of copies/mLStandard Deviation 1.05
Block 2 Site 3 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation2.12 Log of copies/mLStandard Deviation 1.25
Block 2 Site 8 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation1.89 Log of copies/mLStandard Deviation 0.97
Block 2 Site 8 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.28 Log of copies/mLStandard Deviation 1.12
Block 2 Site 8 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation2.00 Log of copies/mLStandard Deviation 1.1
Block 3 Site 1 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.30 Log of copies/mLStandard Deviation 1.17
Block 3 Site 1 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation1.98 Log of copies/mLStandard Deviation 1.08
Block 3 Site 1 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation2.00 Log of copies/mLStandard Deviation 1.07
Block 3 Site 11 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation2.07 Log of copies/mLStandard Deviation 1.09
Block 3 Site 11 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation1.90 Log of copies/mLStandard Deviation 0.77
Block 3 Site 11 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.20 Log of copies/mLStandard Deviation 0.99
Block 4 Site 2 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.36 Log of copies/mLStandard Deviation 1.25
Block 4 Site 2 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation2.12 Log of copies/mLStandard Deviation 1.27
Block 4 Site 2 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation2.22 Log of copies/mLStandard Deviation 1.19
Block 4 Site 12 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation1.76 Log of copies/mLStandard Deviation 0.87
Block 4 Site 12 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation2.10 Log of copies/mLStandard Deviation 1.21
Block 4 Site 12 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation2.35 Log of copies/mLStandard Deviation 1.2
Block 5 Site 6 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation1.78 Log of copies/mLStandard Deviation 1.49
Block 5 Site 6 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation1.79 Log of copies/mLStandard Deviation 0.77
Block 5 Site 6 - CoP AloneChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation1.92 Log of copies/mLStandard Deviation 1.7
Block 5 Site 13 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadSustainment Phase - 6 months after the end of the implementation2.17 Log of copies/mLStandard Deviation 1.15
Block 5 Site 13 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadBaseline Phase - 12 months prior to the start of implementation1.11 Log of copies/mLStandard Deviation 2.89
Block 5 Site 13 - CoP FacilitatedChange in Individual Patients' Records Report Related to HIV Viral LoadImplementation Phase - 12 months during implementation2.38 Log of copies/mLStandard Deviation 1.25

Source: ClinicalTrials.gov · Data processed: May 2, 2026