Epividian / AHF: Positive Pathways - HIV Retention in Care

October 27, 2021 updated by: Epividian

Epividian, Inc. and AIDS Healthcare Foundation: Positive Pathways - HIV Retention in Care RIC-20190212 (Pro00037143)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10521

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90028
        • AHF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HIV-1 diagnosis who are in care at AHF and seen at least once in the last 2 years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Provider will receive an alert of sub-optimal patient attendance using 4 rules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Kept Appointments
Time Frame: 16 months, 01-Nov-2019 to 30-Apr-2021
Pre and post-baseline rate of patients who attended their scheduled office visits.
16 months, 01-Nov-2019 to 30-Apr-2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral suppression
Time Frame: 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
16 months, 01-Nov-2019 to 30-Apr-2021
Ranked Scoring of Implementation effectiveness
Time Frame: 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.
16 months, 01-Nov-2019 to 30-Apr-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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