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

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Behavioral: HIV-ASSIST; Behavioral: DHHS guidelines

• Registration Number: NCT04080765
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-27
• Primary Completion: 2019-07-14
• Study Completion: 2019-07-14
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-ASSIST + DHHS arm	HIV-ASSIST	Decision-making support for ARV selection through DHHS guidelines in conjunction with HIV-ASSIST
HIV-ASSIST + DHHS arm	DHHS guidelines	Decision-making support for ARV selection through DHHS guidelines in conjunction with HIV-ASSIST
DHHS-alone arm	DHHS guidelines	Decision-making support for ARV selection through DHHS guidelines alone

Primary Outcome Measures

Name	Time	Method
Proportion of appropriate ARV selections	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

Name	Time	Method
Time to ARV selection	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.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States