NCT04107233

Brief Summary

This cluster randomized control trial examines whether an audit and feedback study improves care of patients living with HIV/AIDS in a family health team setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

May 31, 2019

Last Update Submit

January 3, 2025

Conditions

Quality of Health CareHIV/AIDSElectronic Health Records

Outcome Measures

Primary Outcomes (1)

  • Up to date viral load

    Percentage of HIV infected patients who have an up to date HIV viral load

    Within six months

Secondary Outcomes (6)

  • Clinic visit

    Within the last 6 months

  • Up-to-date cancer screenings

    1-3 years

  • Vaccinations

    Since 2013

  • Screening for diabetes

    Within 1 year

  • Screening for hypercholesterolemia

    Within 1 year

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Audit and feedback directed at family physicians, including reports a one-on-one meeting.

Behavioral: Audit and Feedback

Control

NO INTERVENTION

Usual care; may receive the intervention at the end of the study if successful

Interventions

Audit and FeedbackBEHAVIORAL

Charts for enrolled physicians will be audited and they will receive feedback, consisting of tailored reports and one-on-one meeting with colleague to review at baseline, 3 months and 6 months

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Family physicians at the St. Michael's Hospital Academic Family Health Team who have at least 20 PLHA.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Andrew Pinto, MSc MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2019

First Posted

September 27, 2019

Study Start

April 3, 2017

Primary Completion

January 31, 2019

Study Completion

July 19, 2021

Last Updated

January 6, 2025

Record last verified: 2024-12

Locations

CA(1)