Epividian / AHF: Positive Pathways - HIV Retention in Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: Alert to provider


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-1<br>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<br>* Provider will receive an alert of sub-optimal patient attendance using 4 rules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Kept Appointments | 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 | 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 | 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 |