Trial results for a study investigating choice architecture for tuberculosis preventive therapy (TPT) delivery in people living with HIV were posted on ClinicalTrials.gov on 2026-03-27. The study found that a choice architecture intervention increased TPT initiation to 5.2% in established ART patients, compared to 2.1% in the standard of care arm.
Background
Tuberculosis (TB) remains a significant concern for persons living with HIV (PWH). Clinical guidelines recommend TB preventive therapy (TPT) for eligible PWH, but real-world delivery often falls short, a phenomenon known as the "science-to-service gap." This gap means that less than 20% of TPT-eligible PWH are offered or initiated on isoniazid preventive therapy (IPT) in many settings, despite the availability of new pharmacological options for shorter TPT regimens. Addressing this disparity is critical for improving health outcomes for PWH and reducing the burden of TB.
Trial design
This completed study, designated as Phase NA, enrolled 50,798 participants across two arms: a "Standard of Care Study Arm" and a "Choice Architecture Study Arm." The trial investigated strategies to improve the delivery of tuberculosis preventive therapy (TPT) for individuals with HIV/AIDS and Tuberculosis. The intervention focused on implementing choice architecture principles to enhance TPT initiation rates.
Key results
The trial reported several key measurements comparing the Choice Architecture Study Arm to the Standard of Care Study Arm:
- Percentage of Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation:
- Standard of Care Study Arm: 70.1%
- Choice Architecture Study Arm: 71.5%
- Percentage of Established ART Patients Also Initiating TPT:
- Standard of Care Study Arm: 2.1%
- Choice Architecture Study Arm: 5.2%
- Percentage of TPT-eligible Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation:
- Standard of Care Study Arm: 77.3%
- Choice Architecture Study Arm: 78.3%
- Percentage of TPT-eligible Established ART Patients Also Initiating TPT:
- Standard of Care Study Arm: 11.5%
- Choice Architecture Study Arm: 13.9%
- Percentage of Patients Started on TPT With Subsequent Discontinuation:
- Standard of Care Study Arm: 2.3%
- Choice Architecture Study Arm: 3.7%
- Clinic Implementation of Choice Architecture as Assessed by Adoption:
- Standard of Care Study Arm: 0 Visits
- Choice Architecture Study Arm: 44,504 Visits
What this means
The results indicate that implementing choice architecture strategies can improve the uptake of tuberculosis preventive therapy (TPT) among persons living with HIV. Notably, the choice architecture intervention led to a more than doubling of TPT initiation rates for established ART patients, from 2.1% to 5.2%. For TPT-eligible established ART patients, initiation increased from 11.5% to 13.9%. The substantial number of clinic visits (44,504) where choice architecture was adopted in the intervention arm, compared to 0 in the standard of care, demonstrates the feasibility of integrating such approaches into clinical practice. While a slight increase in TPT discontinuation was observed in the intervention arm (3.7% vs 2.3%), the overall impact suggests that choice architecture can be an effective tool to bridge the "science-to-service gap" in TPT delivery for PWH, potentially leading to better TB prevention outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04466488, titled "Prevent TB: Choice Architecture for TPT Delivery", were posted on 2026-03-27 on clinicaltrials.gov.