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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: HIV-ASSIST
* Behavioral: DHHS guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students in the Johns Hopkins Schools of Medicine or Nursing, and/or internal medicine residents Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV-ASSIST + DHHS arm<br>Decision-making support for ARV selection through DHHS guidelines in conjunction with HIV-ASSIST | Behavioral: HIV-ASSIST<br>* 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.<br>Behavioral: DHHS guidelines<br>* This is the Department of Health and Human Services HIV/AIDS Treatment Guidelines.<br>|
| Active Comparator: DHHS-alone arm<br>Decision-making support for ARV selection through DHHS guidelines alone | Behavioral: DHHS guidelines<br>* This is the Department of Health and Human Services HIV/AIDS Treatment Guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of appropriate ARV selections | Median score (out of 100%) on survey of 10 standardized case scenarios, as scored in comparison to a reference panel of HIV experts. | Up to one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ARV selection | Time in minutes to ARV selection for standardized case scenarios between trainees using HIV-ASSIST and those using the DHHS guidelines. | Up to one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision analysis, HIV, education