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Epividian / AHF: Positive Pathways - HIV Retention in Care

Sponsor
Epividian (Industry)
Overall Status
Completed
CT.gov ID
NCT04147832
Collaborator
AIDS Healthcare Foundation (Other), ViiV Healthcare (Industry)
10,521
Enrollment
1
Location
9.8
Actual Duration (Months)
1071
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the effectiveness of a clinical decision support system (CDSS) combined with enhanced patient contact to retain HIV+ patients in care with AIDS Healthcare Foundation. Specifically, the study aims to evaluate the effectiveness of having the patient's primary caregiver (or dedicated case manager) telephone the patient when the patient is identified as a significant risk to loss of follow-up (at-risk patients) based upon pre-defined criteria. The secondary objective Gain a better understanding about the implementation of the study's procedures in clinical practice by evaluating survey responses delivered to participating healthcare providers and AHF staff members engaging with the study's intervention.

Condition or Disease Intervention/Treatment Phase
  • Other: Alert to provider

Detailed Description

Retention in care and re-engagement in care is a primary concern in HIV treatment today and a major obstacle in the US to reach the UNAIDS 90-90-90 goal [1]. The U.S. CDC supports the use of HIV surveillance data to identify not-in-care (NIC) patients and re-link them to care (Data-to-Care). The optimal strategy for identifying patients for Data-to-Care is unknown. It has been postulated that by increasing follow up of high-risk patients not meeting the retention in care measures, the number of people living with HIV being retained in care may be increased by 10%.

Multiple HIV clinics within the AHF organization in the US are eligible for study participation. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective EHRs and identified through CHORUS, a CDSS developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study.

The CDSS will generate alerts to the providers warning of suboptimal patient attendance among the population. The alerts will be generated using the following four criteria of at-risk of loss to follow-up:

  • At Risk #1: No visit in the previous 4 months and no scheduled appointment in the subsequent 2 months.

  • High Risk #2: Single appointment in the previous year, a missed appointment in the previous month and no scheduled appointment in the next 2 months.

  • High Risk #3: Those with 2 missed sequential appointments, and no scheduled appointment in the subsequent 7 days.

  • High Risk #4: Those with an attended appointment >3 months ago and their most recent viral load >1000 copies/ml.

Study Design

Study Type:
Observational
Actual Enrollment :
10521 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Epividian, Inc. and AIDS Healthcare Foundation: Positive Pathways - HIV Retention in Care RIC-20190212 (Pro00037143)
Actual Study Start Date :
Oct 5, 2020
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
HIV-1

HIV-1+, males, females, transgender, ≥18 years of age, seen at any AHF clinic within the last two years and whose care is documented in the AHF electronic health records system.

Other: Alert to provider
Provider will receive an alert of sub-optimal patient attendance using 4 rules.

Outcome Measures

Primary Outcome Measures

  1. Rate of Kept Appointments [16 months, 01-Nov-2019 to 30-Apr-2021]

    Pre and post-baseline rate of patients who attended their scheduled office visits.

Secondary Outcome Measures

  1. Viral suppression [16 months, 01-Nov-2019 to 30-Apr-2021]

    Proportion of patients with an undetectable viral load defined as patients with a viral load <50 copies/mL out of all patients seen at the practice in the past 2 years

  2. Ranked Scoring of Implementation effectiveness [16 months, 01-Nov-2019 to 30-Apr-2021]

    Evaluation of healthcare providers' survey responses regarding implementation context of appropriateness, feasibility, adoption, appropriateness and effectiveness. With providers' scores ranked 1 (lowest/worst) to 5 (highest/best), will report pre and post-baseline averages and distributions of scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • HIV-1+

  • 18 years old or older

  • Any sex

  • Seen at least once in a US-based AHF clinic in the last 2 years with care documented in the EHR

Exclusion Criteria:

  • Patients known to have left the practice

  • Patients who choose not to be contacted about their care via telephone

Contacts and Locations

Locations

Site City State Country Postal Code
1 AHF Los Angeles California United States 90028

Sponsors and Collaborators

  • Epividian
  • AIDS Healthcare Foundation
  • ViiV Healthcare

Investigators

  • Principal Investigator: Michael Wohlfeiler, MD, AIDS Healthcare Foundation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Epividian
ClinicalTrials.gov Identifier:
NCT04147832
Other Study ID Numbers:
  • Pro00037143
First Posted:
Nov 1, 2019
Last Update Posted:
Oct 29, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

Study Results

No Results Posted as of Oct 29, 2021