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Antiretroviral Therapy Selection: Comparing HIV Clinical Guidelines With HIV-ASSIST, an Online Decision-support Tool

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ClinicalTrials.gov Identifier: NCT04080765
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 4, 2019
First Posted Date  ICMJE September 6, 2019
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE June 27, 2019
Actual Primary Completion Date July 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
Proportion of appropriate ARV selections [ Time Frame: Up to one hour ]
Median score (out of 100%) on survey of 10 standardized case scenarios, as scored in comparison to a reference panel of HIV experts.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
Time to ARV selection [ Time Frame: Up to one hour ]
Time in minutes to ARV selection for standardized case scenarios between trainees using HIV-ASSIST and those using the DHHS guidelines.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiretroviral Therapy Selection: Comparing HIV Clinical Guidelines With HIV-ASSIST, an Online Decision-support Tool
Official Title  ICMJE Prospective Validation Study of a Antiretroviral Therapy (ARV) Decision Support Tool
Brief Summary

HIV-ASSIST is an online decision support tool created by Johns Hopkins faculty that utilizes standard patient variables, and provides treatment recommendations and tailored educational content to assist providers learn HIV treatment principles and support decision-making.

The research goal is to determine the difference in percentage of appropriate antiretroviral therapy (ART) selection (based upon a reference standard of HIV experts and guidelines) for a set of hypothetical patient scenarios, comparing a group of trainees with access to current national DHHS guidelines (control), and a group using HIV-ASSIST (intervention) in addition to guidelines.

The investigators proposed a randomized study design, in which an electronic survey/questionnaire with 10 HIV case vignettes are presented to study participants. Medical and nursing students and internal medicine residents will be eligible to participate.

Participants providing informed consent will be randomized to receiving access to either online Department of Health and Human Services (DHHS) HIV guidelines, or the HIV-ASSIST online tool to support participants' decision making. Participants will be asked to indicate participants' ART regimen of choice for each case scenario. The proportion of appropriate ART selections will be evaluated comparing the intervention and control arms. The investigators will additionally report the time required for trainees to complete ART selections for the presented clinical vignettes.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Hiv
Intervention  ICMJE
  • Behavioral: HIV-ASSIST
    HIV-ASSIST is an online interactive patient-based tool that allows for individualized HIV treatment recommendations through the synthesis of patient-specific factors with existing guidelines and evidence.
  • Behavioral: DHHS guidelines
    This is the Department of Health and Human Services HIV/AIDS Treatment Guidelines.
Study Arms  ICMJE
  • Experimental: HIV-ASSIST + DHHS arm
    Decision-making support for ARV selection through DHHS guidelines in conjunction with HIV-ASSIST
    Interventions:
    • Behavioral: HIV-ASSIST
    • Behavioral: DHHS guidelines
  • Active Comparator: DHHS-alone arm
    Decision-making support for ARV selection through DHHS guidelines alone
    Intervention: Behavioral: DHHS guidelines
Publications * Ramirez JA, Maddali MV, Nematollahi S, Li JZ, Shah M. New Strategies in Clinical Guideline Delivery: Randomized Trial of Online, Interactive Decision Support Versus Guidelines for Human Immunodeficiency Virus Treatment Selection by Trainees. Clin Infect Dis. 2021 May 4;72(9):1608-1614. doi: 10.1093/cid/ciaa299.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
138
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 14, 2019
Actual Primary Completion Date July 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Students in the Johns Hopkins Schools of Medicine or Nursing, and/or internal medicine residents

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04080765
Other Study ID Numbers  ICMJE IRB00174416
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maunank Shah, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP