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

Johns Hopkins University

Status: Completed

Conditions: Hiv

Treatments: Behavioral: HIV-ASSIST; Behavioral: DHHS guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT04080765

IRB00174416

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

HIV-ASSIST + DHHS arm

Experimental group

Description:

Decision-making support for ARV selection through DHHS guidelines in conjunction with HIV-ASSIST

Treatment:

Behavioral: HIV-ASSIST

Behavioral: DHHS guidelines

DHHS-alone arm

Active Comparator group

Description:

Decision-making support for ARV selection through DHHS guidelines alone

Treatment:

Behavioral: DHHS guidelines