HIV/AIDS Clinical Trial
Official title:
Epividian, Inc. and AIDS Healthcare Foundation: Positive Pathways - HIV Retention in Care RIC-20190212 (Pro00037143)
NCT number | NCT04147832 |
Other study ID # | Pro00037143 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2020 |
Est. completion date | July 31, 2021 |
Verified date | August 2021 |
Source | Epividian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | AHF | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Epividian | AIDS Healthcare Foundation, ViiV Healthcare |
United States,
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* Note: There are 26 references in all — Click here to view all references
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 |
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