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Evaluation of Clinical Impacts and Costs of eHealth in Rwanda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283929
Recruitment Status : Active, not recruiting
First Posted : February 25, 2020
Last Update Posted : February 28, 2020
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Ministry of Health, Rwanda
Rwanda Biomedical Centre
Partners in Health
Innovative Support to Emergencies Diseases and Disasters
University of Pittsburgh
Jembi Health Systems
Brown University
Information provided by (Responsible Party):
Dr. Jeanine Condo, National University, Rwanda

Brief Summary:
This study will estimate the impact of a suite of clinical decision-support tools on structural, process, and clinical outcomes related to HIV care. The "enhanced EMR" package under investigation will include EMR monitoring tools, data quality control procedures and support, patient reports, alerts, and reminders about patient care. This intervention will be delivered by the Ministry of Health and Rwanda Biomedical Centre and monitored by the study team led by University of Rwanda's School of Public Health and Brown University.

Condition or disease Intervention/treatment Phase
HIV/AIDS and Infections Electronic Medical Records Clinical Decision Support System Other: Experimental: Intervention 1 (Int1) Other: Experimental: Intervention 2 (Int2) Other: Experimental: Intervention 3 (Int3) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Clinical Impacts and Costs of eHealth in Rwanda Using Innovative Frameworks and Local Capacity Building
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention 1 (Int1)
Facilities assigned to the enhanced package for Int1 will receive alerts and reminders to promote linkage of HIV positives from diagnosis to care.
Other: Experimental: Intervention 1 (Int1)
This intervention will consist of the following additions to the EMR package. A link on the clinician's homepage to enrol a new HIV+ patient in the EMR which will open a form for (1) entering patient demographics (2) adding the contact home address or description of area, phone number (if available), (3) the peer educator contacts (4) recording the HIV+ result and date. A report will be added that is run every week to identify HIV+ patients not linked to care. The patients identified will be checked with paper records to ensure they have definitely not visited, then contacted after one, 2 weeks and 4 weeks if he/she did not show up. After two attempted contacts, if the patient is not yet linked to care he/she will be visited at home by the health facility social worker using routine home visits by health care providers.
Other Name: Alerts and reminders to improve the linkage from HIV testing to care

No Intervention: Control 1 (Ctrl1)
Facilities assigned to the Ctrl1 will not receive any additional equipment, software tools, training or other forms of support.
Experimental: Intervention 2 (Int2)
Randomise the Intervention 1 group into two additional arms: Intervention 2 (Int2) and Control (Ctrl2). Facilities assigned to Int2 will also receive alerts and reminders to improve lab reporting as part of their enhanced package.
Other: Experimental: Intervention 1 (Int1)
This intervention will consist of the following additions to the EMR package. A link on the clinician's homepage to enrol a new HIV+ patient in the EMR which will open a form for (1) entering patient demographics (2) adding the contact home address or description of area, phone number (if available), (3) the peer educator contacts (4) recording the HIV+ result and date. A report will be added that is run every week to identify HIV+ patients not linked to care. The patients identified will be checked with paper records to ensure they have definitely not visited, then contacted after one, 2 weeks and 4 weeks if he/she did not show up. After two attempted contacts, if the patient is not yet linked to care he/she will be visited at home by the health facility social worker using routine home visits by health care providers.
Other Name: Alerts and reminders to improve the linkage from HIV testing to care

Other: Experimental: Intervention 2 (Int2)
The data on availability of VL results in the EMR will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for 8 months or more and does not have a viral load result in the EMR. The alert will be displayed on the patient summary and on the consult sheets, with text requesting the clinician orders a VL.
Other Name: Alerts and reminders to improve the quality and completeness of lab results in the EMR

No Intervention: Control 2 (Ctrl2)
Facilities assigned to the Ctrl2 will not receive any additional equipment, software tools, training or other forms of support to improve lab reporting as part of their enhanced EMR.
Experimental: Intervention 3 (Int3)
Randomise the Intervention 2 group into two additional arms: Intervention 3 (Int3) or Control (Ctrl3). Facilities assigned to Int3 will receive alerts and reminders to improve clinical response to the detection of treatment failure as part of their enhanced package.
Other: Experimental: Intervention 1 (Int1)
This intervention will consist of the following additions to the EMR package. A link on the clinician's homepage to enrol a new HIV+ patient in the EMR which will open a form for (1) entering patient demographics (2) adding the contact home address or description of area, phone number (if available), (3) the peer educator contacts (4) recording the HIV+ result and date. A report will be added that is run every week to identify HIV+ patients not linked to care. The patients identified will be checked with paper records to ensure they have definitely not visited, then contacted after one, 2 weeks and 4 weeks if he/she did not show up. After two attempted contacts, if the patient is not yet linked to care he/she will be visited at home by the health facility social worker using routine home visits by health care providers.
Other Name: Alerts and reminders to improve the linkage from HIV testing to care

Other: Experimental: Intervention 2 (Int2)
The data on availability of VL results in the EMR will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for 8 months or more and does not have a viral load result in the EMR. The alert will be displayed on the patient summary and on the consult sheets, with text requesting the clinician orders a VL.
Other Name: Alerts and reminders to improve the quality and completeness of lab results in the EMR

Other: Experimental: Intervention 3 (Int3)
The data on VL results in the EMR showing detectable virus will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for at least 12 months and the VL result in the EMR shows > 1000 copies/mm3. The alert will be displayed on the patient summary and on the consult sheets requesting actions to address treatment failure (change first line medication, start second line medication, repeat VL, counselling on treatment adherence). A report will also be added to regularly check for patients with high viral load.
Other Name: Alerts and reminders following treatment failure detected by CD4 or viral load improve clinical action

No Intervention: Control (Ctrl3)
Facilities assigned to Ctrl3 will not receive alerts and reminders to improve clinical response to the detection of treatment failure as part of their enhanced package.



Primary Outcome Measures :
  1. Rate of linkage to care among HIV-positive patients [ Time Frame: 12 months ]

    Denominator: All adults (18 or older) with HIV positive test results recorded in the EMR at a study facility. Patients who die in the time between receiving a positive test result and the outcome measurement at 3 months will be excluded.

    Numerator: Subset of these patients who are linked to care at a study facility within 3 months


  2. Percentage of ART patients have viral load results in EMR (initial) [ Time Frame: 10 months ]

    Denominator: Adult patients on ART completing their 6th month of treatment, thus becoming eligible for viral load monitoring.

    Numerator: Subset of these patients with VL results in the EMR 2 months after becoming eligible for testing


  3. Percentage of ART patients with treatment failure experience clinical action [ Time Frame: 12 months ]

    Denominator: Adult patients who have been on ART for at least 12 months and experience treatment failure:

    1. Virologic (viral load ≥ 1000 copies/ml)
    2. Immunological (>50% change in CD4 from highest previous value)

    Numerator: Subset of these patients who have a recorded clinical action in response to treatment failure within 1 month of the detected treatment failure.


  4. Percentage of patients who experience treatment failure who are fully suppressed 4 months after the point of failure [ Time Frame: 12 months ]

    Denominator: Adult patients who have been on ART for at least 12 months (first eligible for VL testing at 6 months, first expected result 8 months, retest after 4 months) and were found to have possible treatment failure.

    Numerator: Subset of these patients who are fully suppressed (viral load < 1000 copies /ml) 4 months after the point of treatment failure.



Secondary Outcome Measures :
  1. Time from HIV+ test result to linkage to care [ Time Frame: 3 months ]
    All adults with HIV positive test results recorded in the EMR at a study who are linked to care at a study facility within 3 months

  2. Percentage of ART patients have viral load results in EMR (annual) [ Time Frame: 12 months ]

    Denominator: Adult patients on ART with at least 12th months of treatment, thus becoming eligible for annual viral load monitoring.

    Numerator: Subset of these patients with VL results in the EMR 2 months after becoming eligible for testing


  3. Time from detection of treatment failure to clinical action [ Time Frame: 11 months ]
    Every existing ART patient who has been on ART for at least 18 months and experiences treatment failure between the start of the trial and study month 11



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is a health center with an average (3 month) monthly volume of 50-700 patients
  • Is owned and operated by the public sector or faith-based institutions
  • Has a power source
  • Has network connectivity
  • Has at least 3 computers and 1 printer

Exclusion criteria:

  • District hospitals (typically with high patient volume)
  • Privately owned facilities
  • Facilities operated by Partners in Health (who already run a version of the intervention)
  • Facilities that only offer PMTCT services
  • Facilities that run OpenMRS version 1.9 (rather than 1.6)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283929


Locations
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Rwanda
School of Public Health
Kigali, Rwanda, 250
Sponsors and Collaborators
National University, Rwanda
Centers for Disease Control and Prevention
Ministry of Health, Rwanda
Rwanda Biomedical Centre
Partners in Health
Innovative Support to Emergencies Diseases and Disasters
University of Pittsburgh
Jembi Health Systems
Brown University
Investigators
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Principal Investigator: Fraser HAMISH, MBChB Brown University: hamish_fraser@brown.edu
Principal Investigator: Jeanine CONDO, MD, PhD University of Rwanda
Publications:

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Responsible Party: Dr. Jeanine Condo, Associate Professor, National University, Rwanda
ClinicalTrials.gov Identifier: NCT04283929    
Other Study ID Numbers: GH000782
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public data sets will be accessible and shared to anyone who needs them upon writing request letter to the RBC HIV division through Principal Investigator and get approval written letter to access data.
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: 1 month
Access Criteria:
  • Interest in working on similar area
  • Writing a letter of request
  • Sign data sharing agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases