HIV/AIDSNCT04147832
Epividian / AHF: Positive Pathways - HIV Retention in Care
An observational study of HIV/AIDS, run by Epividian at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Alert to provider
- How many people
- 10,521 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with HIV-1 diagnosis who are in care at AHF and seen at least once in the last 2 years.
Who may be able to join
- 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
Who cannot join
- Patients known to have left the practice
- Patients who choose not to be contacted about their care via telephone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Alert to provider
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert to providerOther
Provider will receive an alert of sub-optimal patient attendance using 4 rules.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Alert to provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Kept Appointments
Pre and post-baseline rate of patients who attended their scheduled office visits.
Measured: 16 months, 01-Nov-2019 to 30-Apr-2021
Secondary outcomes (2)
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
Measured: 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.
Measured: 16 months, 01-Nov-2019 to 30-Apr-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start5 Oct 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epividian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation, ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Michael Wohlfeiler, MD, Principal investigator, AIDS Healthcare Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147832
- Sponsor's protocol ID
- Pro00037143
- Status last verified
- Aug 2021
- First submitted
- 30 Oct 2019
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kazanjian P. UNAIDS 90-90-90 Campaign to End the AIDS Epidemic in Historic Perspective. Milbank Q. 2017 Jun;95(2):408-439. doi: 10.1111/1468-0009.12265.
PubMed 28589602Bakken S. An informatics infrastructure is essential for evidence-based practice. J Am Med Inform Assoc. 2001 May-Jun;8(3):199-201. doi: 10.1136/jamia.2001.0080199.
PubMed 11320064Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med. 2003 Jun 19;348(25):2526-34. doi: 10.1056/NEJMsa020847. No abstract available.
PubMed 12815139Bakken S, Cimino JJ, Hripcsak G. Promoting patient safety and enabling evidence-based practice through informatics. Med Care. 2004 Feb;42(2 Suppl):II49-56. doi: 10.1097/01.mlr.0000109125.00113.f4.
PubMed 14734942Jenders RA, Osheroff JA, Sittig DF, Pifer EA, Teich JM. Recommendations for clinical decision support deployment: synthesis of a roundtable of medical directors of information systems. AMIA Annu Symp Proc. 2007 Oct 11;2007:359-63.
PubMed 18693858Schulman J, Kuperman GJ, Kharbanda A, Kaushal R. Discovering how to think about a hospital patient information system by struggling to evaluate it: a committee's journal. J Am Med Inform Assoc. 2007 Sep-Oct;14(5):537-41. doi: 10.1197/jamia.M2436. Epub 2007 Jun 28.
PubMed 17600095Middleton B, Hammond WE, Brennan PF, Cooper GF. Accelerating U.S. EHR adoption: how to get there from here. recommendations based on the 2004 ACMI retreat. J Am Med Inform Assoc. 2005 Jan-Feb;12(1):13-9. doi: 10.1197/jamia.M1669. Epub 2004 Oct 18.
PubMed 15492028Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
PubMed 15755945Poon EG, Wald J, Bates DW, Middleton B, Kuperman GJ, Gandhi TK. Supporting patient care beyond the clinical encounter: three informatics innovations from partners health care. AMIA Annu Symp Proc. 2003;2003:1072.
PubMed 14728575Bakken S, Roberts WD, Chen E, Dilone J, Lee NJ, Mendonca E, Markatou M. PDA-based informatics strategies for tobacco use screening and smoking cessation management: a case study. Stud Health Technol Inform. 2007;129(Pt 2):1447-51.
PubMed 17911954Bindoff IK, Tenni PC, Peterson GM, Kang BH, Jackson SL. Development of an intelligent decision support system for medication review. J Clin Pharm Ther. 2007 Feb;32(1):81-8. doi: 10.1111/j.1365-2710.2007.00801.x.
PubMed 17286791Dickey J, Girard DE, Geheb MA, Cassel CK. Using systems-based practice to integrate education and clinical services. Med Teach. 2004 Aug;26(5):428-34. doi: 10.1080/01421590410001730967.
PubMed 15369883Grant RW, Wald JS, Poon EG, Schnipper JL, Gandhi TK, Volk LA, Middleton B. Design and implementation of a web-based patient portal linked to an ambulatory care electronic health record: patient gateway for diabetes collaborative care. Diabetes Technol Ther. 2006 Oct;8(5):576-86. doi: 10.1089/dia.2006.8.576.
PubMed 17037972Hsieh TC, Kuperman GJ, Jaggi T, Hojnowski-Diaz P, Fiskio J, Williams DH, Bates DW, Gandhi TK. Characteristics and consequences of drug allergy alert overrides in a computerized physician order entry system. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):482-91. doi: 10.1197/jamia.M1556. Epub 2004 Aug 6.
PubMed 15298998Lester WT, Ashburner JM, Grant RW, Chueh HC, Barry MJ, Atlas SJ. Mammography FastTrack: an intervention to facilitate reminders for breast cancer screening across a heterogeneous multi-clinic primary care network. J Am Med Inform Assoc. 2009 Mar-Apr;16(2):187-95. doi: 10.1197/jamia.M2813. Epub 2008 Dec 11.
PubMed 19074304
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epividian, Inc. and AIDS Healthcare Foundation: Positive Pathways - HIV Retention in Care RIC-20190212 (Pro00037143)
- ClinicalTrials.gov ID
- NCT04147832
- Acronym / sponsor ID
- Pro00037143
- Conditions
- HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,521 participants (actual)
- Lead sponsor
- EpividianIndustry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation, ViiV Healthcare
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 | – | Other: Alert to providerHIV-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HIV-1 diagnosis who are in care at AHF and seen at least once in the last 2 years.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients known to have left the practice
- Patients who choose not to be contacted about their care via telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alert to providerProvider will receive an alert of sub-optimal patient attendance using 4 rules. | Other | HIV-1 |
Primary outcome
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.
2 secondary outcomes
Viral suppression
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 28589602Kazanjian P. UNAIDS 90-90-90 Campaign to End the AIDS Epidemic in Historic Perspective. Milbank Q. 2017 Jun;95(2):408-439. doi: 10.1111/1468-0009.12265.
- Background: PubMed 11320064Bakken S. An informatics infrastructure is essential for evidence-based practice. J Am Med Inform Assoc. 2001 May-Jun;8(3):199-201. doi: 10.1136/jamia.2001.0080199.
- Background: PubMed 12815139Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med. 2003 Jun 19;348(25):2526-34. doi: 10.1056/NEJMsa020847. No abstract available.
- Background: PubMed 14734942Bakken S, Cimino JJ, Hripcsak G. Promoting patient safety and enabling evidence-based practice through informatics. Med Care. 2004 Feb;42(2 Suppl):II49-56. doi: 10.1097/01.mlr.0000109125.00113.f4.
- Background: PubMed 18693858Jenders RA, Osheroff JA, Sittig DF, Pifer EA, Teich JM. Recommendations for clinical decision support deployment: synthesis of a roundtable of medical directors of information systems. AMIA Annu Symp Proc. 2007 Oct 11;2007:359-63.
- Background: PubMed 17600095Schulman J, Kuperman GJ, Kharbanda A, Kaushal R. Discovering how to think about a hospital patient information system by struggling to evaluate it: a committee's journal. J Am Med Inform Assoc. 2007 Sep-Oct;14(5):537-41. doi: 10.1197/jamia.M2436. Epub 2007 Jun 28.
- Background: PubMed 15492028Middleton B, Hammond WE, Brennan PF, Cooper GF. Accelerating U.S. EHR adoption: how to get there from here. recommendations based on the 2004 ACMI retreat. J Am Med Inform Assoc. 2005 Jan-Feb;12(1):13-9. doi: 10.1197/jamia.M1669. Epub 2004 Oct 18.
- Background: PubMed 15755945Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
- Background: PubMed 14728575Poon EG, Wald J, Bates DW, Middleton B, Kuperman GJ, Gandhi TK. Supporting patient care beyond the clinical encounter: three informatics innovations from partners health care. AMIA Annu Symp Proc. 2003;2003:1072.
- Background: PubMed 17911954Bakken S, Roberts WD, Chen E, Dilone J, Lee NJ, Mendonca E, Markatou M. PDA-based informatics strategies for tobacco use screening and smoking cessation management: a case study. Stud Health Technol Inform. 2007;129(Pt 2):1447-51.
- Background: PubMed 17286791Bindoff IK, Tenni PC, Peterson GM, Kang BH, Jackson SL. Development of an intelligent decision support system for medication review. J Clin Pharm Ther. 2007 Feb;32(1):81-8. doi: 10.1111/j.1365-2710.2007.00801.x.
- Background: PubMed 15369883Dickey J, Girard DE, Geheb MA, Cassel CK. Using systems-based practice to integrate education and clinical services. Med Teach. 2004 Aug;26(5):428-34. doi: 10.1080/01421590410001730967.
- CHORUS (Clinical Decision Support System)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wohlfeiler, MD principal investigator
AIDS Healthcare Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Epividian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Kept Appointments (time frame: 16 months, 01-Nov-2019 to 30-Apr-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147832, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.