CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50,798 enrolled
Drug / intervention
Choice Architecturebehavioral
Likely dose
Not stated in record
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Search/NCT04466488
NCT04466488N/ACompleted

Prevent TB: Application of Choice Architecture to Implement TB Preventive Therapy in South Africa

Johns Hopkins University·interventional·Posted Jul 10, 2020·Updated Mar 27, 2026

In Brief

A clinical study evaluating Choice Architecture for HIV/AIDS and Tuberculosis. Completed, enrolled 50,798 participants across 1 site.

Detailed Summary

Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what the investigators know works and what is actually delivered at the clinic-level to patients, is known as the "science-to-service gap." In the realm of tuberculosis (TB) prevention, this gap is reflected in \<20% of TB preventive therapy (TPT) -eligible persons living with HIV (PWH) being offered or initiated on isoniazid preventive therapy (IPT) in many settings. Recent innovation in TPT have brought new pharmacological options allowing for shorter courses, intermittent dosing, or both. The overarching goal of this study is to identify a generalizable approach to overcome current barriers to delivery of TPT in order to achieve high levels of TPT delivery during routine care in public clinics. Multiple approaches are in standard use to change prescribing behavior including in service training, audit and feedback, clinical mentoring, the use of clinical decision aids, and "academic detailing." However, the overall change is generally modest. To achieve a substantial increase in TPT delivery (from current approximately 20% to 60-80%) will require a fundamental change in the approach to selecting patients for TPT - a redesign of the choice architecture of TPT prescribing. Methods: The investigators are proposing a choice architecture that makes prescribing TPT the "default" or standard option and that for TPT not to be prescribed will require a choice by a clinician to "opt-out" of TPT for a specific patient. The investigators are proposing a cluster randomized design to test the choice architecture approach to increasing delivery of TPT. Clinics will be randomized to one of two strategies: (1) standard implementation and (2) choice architecture default TPT. Because of the clinic-level nature of the implementation strategies, all PWH receiving care at a clinic will be exposed to the standard implementation or TPT routinization implementation. Clinical process data will be used to assess the effectiveness of each strategy to determine the proportion of PWH (1) screened for TPT, (2) eligible for TPT, and (3) prescribed TPT. Significance: TB is the leading cause of death among PWH in South Africa and elsewhere on the continent. TPT is a proven intervention to reduce mortality among PWH but is not widely prescribed. This study seeks to identify an implementation strategy to reach optimal TPT prescribing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 10, 2020
Enrollment StartSep 15, 2021
Primary CompletionNov 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.0 years ago

Interventions

Choice Architecturebehavioral

1. Providers will receive general training on TPT benefits, indications, and contra-indications. 2. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole. 3. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed