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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adult (≥18 years old) patients initiating ART

• Adult (≥18 years old) patients already on ART and coming for ART re-prescribing

Locations
Other Locations
South Africa
Perinatal HIV Research Unit
RECRUITING
Soweto
Contact Information
Primary
Christopher Hoffmann, MD, MPH
choffmann@jhmi.edu
410-614-4257
Time Frame
Start Date: 2021-09-15
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 36
Treatments
No_intervention: Standard of care study arm
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have presumptive TB. Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
Experimental: Choice Architecture study arm
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.~The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be automatically included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov