Working… Menu

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

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

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.

Condition or disease Intervention/treatment Phase
Hiv Behavioral: HIV-ASSIST Behavioral: DHHS guidelines Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prospective Validation Study of a Antiretroviral Therapy (ARV) Decision Support Tool
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : July 14, 2019
Actual Study Completion Date : July 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIV-ASSIST + DHHS arm
Decision-making support for ARV selection through DHHS guidelines in conjunction with HIV-ASSIST
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.

Active Comparator: DHHS-alone arm
Decision-making support for ARV selection through DHHS guidelines alone
Behavioral: DHHS guidelines
This is the Department of Health and Human Services HIV/AIDS Treatment Guidelines.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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 identifier (NCT number): NCT04080765

Layout table for location information
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Layout table for investigator information
Principal Investigator: Maunank Shah, MD, PhD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins University Identifier: NCT04080765    
Other Study ID Numbers: IRB00174416
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
decision analysis