Epividian / AHF: Positive Pathways - HIV Retention in Care

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147832
• Other study ID #: Pro00037143
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Epividian
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10521
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
United States	AHF	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Epividian	AIDS Healthcare Foundation, ViiV Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (26)

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McGowan JJ, Cusack CM, Poon EG. Formative evaluation: a critical component in EHR implementation. J Am Med Inform Assoc. 2008 May-Jun;15(3):297-301. doi: 10.1197/jamia.M2584. Epub 2008 Feb 28. — View Citation

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Yehia BR, French B, Fleishman JA, Metlay JP, Berry SA, Korthuis PT, Agwu AL, Gebo KA; HIV Research Network. Retention in care is more strongly associated with viral suppression in HIV-infected patients with lower versus higher CD4 counts. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):333-9. doi: 10.1097/QAI.0000000000000023. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   CHORUS (Clinical Decision Support System)