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OpenTrials
Completed

NCT Number: NCT04080765

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

HIV-ASSIST

Behavioral

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.

DHHS guidelines

Behavioral

This is the Department of Health and Human Services HIV/AIDS Treatment Guidelines.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Prospective Validation Study of a Antiretroviral Therapy (ARV) Decision Support Tool

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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