Choice Architecture Based TB Preventive Therapy Prescribing

Summary

Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what 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 (PLWH) 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. A 12-dose once-weekly rifapentine and isoniazid (3HP) regimen has been demonstrated to be effective and well tolerated. This regimen has several potential advantages over IPT; however, if patients are never assessed for 3HP eligibility and 3HP is not prescribed, TPT packets will remain on pharmacy shelves and the potential health benefits will not reach those who need it.

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. 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.

Methods: Investigators will use a cluster randomized design with the larger IMPAACT4TB (I4TB) program to deliver 3HP to countries in Africa, Asia, and Latin America. A subset of countries and clinics within these I4TB countries will be included with each clinic the unit of randomization. Clinics within study countries will be randomized to one of two strategies: (1) standard implementation within the UNITAID project (clinic training on TPT along with posters and other standard medication material) and (2) choice architecture default TPT.

Clinical process data will be used to assess the effectiveness of each strategy to determine the proportion of PLWH (1) screened for TB preventive therapy, (2) eligible for TPT, and (3) prescribed TPT.

Significance: Identifying a pragmatic approach will lead the way for improving TPT prescribing across the study sites. It will furthermore contribute to implementation science at large in describing implementation strategies that may be applied to clinic-level implementation of other innovations.

Conditions

• HIV/AIDS
• Tuberculosis

Interventions

BEHAVIORAL

Choice Architecture

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. This will be adapted to the country context and may include a pre-printed prescription pad (Mozambique), adaptations in clinical stationary (Zimbabwe), or adaptations to an electronic prescribing system (Malawi). 3. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed

Sponsors & Collaborators

• KNCV Tuberculosis Foundation

  collaborator OTHER

• Clinton Health Access Initiative, Zimbabwe

  collaborator OTHER

• Aurum Institute

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Christopher Hoffmann, MD, MPH · Johns Hopkins University

• Jonathan Golub, PhD, MPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-29

Primary Completion

2022-10-31

Completion

2022-10-31

Countries

• Malawi
• Mozambique
• Zimbabwe

Study Locations