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

Prospective Validation Study of a Antiretroviral Therapy (ARV) 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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: HIV-ASSIST; Behavioral: DHHS guidelines

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): July 14, 2019
• Study Completion (Actual): July 14, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: HIV; education; decision analysis
• Other Study ID Numbers: IRB00174416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No