Charlotte Retention in Care Study

NCT03584048 | Completed DMC

• 1 other identifier: HO-18-19095
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of the Charlotte Retention in Care study is to assess if clinical decision support systems (CDSS) that produce standardized alerts for measures of retention in care across clinics in the city of Charlotte, North Carolina have the ability to increase retention in care measures within clinics and in surveillance reports.

Conditions

HIV I Infection

Outcome Measures

Primary Outcomes (1)

• Engagement level

  Pre and post-baseline engagement level. Engagement level is defined as patients with 0, 1, or 2+ visits to physician (identified as a visit that included the collection of 1 viral load and/or 1 CD4 count lab test).

  12 months, 01-Nov-2018 to 31-Oct-2019

Secondary Outcomes (1)

• Kept appointment

  12 months, 01-Nov-2018 to 31-Oct-2019

Study Arms (1)

HIV-1

HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years.

Other: Alert to provider

Interventions

Alert to provider OTHER

Providers receive alerts of sub-optimal patient attendance using 4 rules.

HIV-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years.

You may qualify if:

• HIV-1+
• Any gender
• years old or older
• Residing in the Charlotte, North Carolina metropolitan area
• At least a single entry in the EHR in the last 2 years

Sponsors & Collaborators

• Epividian: lead
• ViiV Healthcare: collaborator

Study Sites (4)

Atrium Health

Charlotte, North Carolina, 28209, United States

Location

Amity Group Foundation

Charlotte, North Carolina, 28215, United States

Location

Ballantyne Family Medicine

Charlotte, North Carolina, 28215, United States

Location

Rosedale Medical

Huntersville, North Carolina, 28078, United States

Location

Related Publications (23)

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Study Officials

• Michael Leonard, MD

  Atrium Health (Carolinas HealthCare System)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 17 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: July 12, 2018
• Study Start: July 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 4, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)