Prevent TB: Application of Choice Architecture to Implement TB Preventive Therapy in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50,798
- 试验地点
- 1
- 主要终点
- Percentage of Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation
研究概览
简要总结
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.
详细描述
BACKGROUND
HIV associated mortality and TB disease in LMIC:
TB is the leading cause of death due to an infectious agent worldwide. Among PWH in low and middle income countries (LMIC), TB represents the leading cause of mortality among PWH. South Africa is particularly affected by the syndemic of HIV and TB with an estimated HIV prevalence in 2017 of 7.2 million and TB incidence of 567/100,000 population with over 60% of TB cases among PWH. There were an estimated 78,000 deaths from TB in South Africa in 2017; 56,000 of the deaths among PWH. Findings from the investigators' group suggest this is likely an underestimate of true TB disease and TB related mortality.
TB preventive therapy reduces TB disease and mortality:
For the past 30 years isoniazid based TPT has been known to reduce the risk of TB among PWH. Multiple studies have subsequently confirmed and strengthened this finding. Following cohort studies conducted in South Africa and Brazil by the investigators' team that showed marked reductions in TB incidence for PWH, clinical trials of isoniazid preventive therapy have reported up to a 70% reduction in TB incidence among PWH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
The data identified by clinic allocation will be blinded to the PI and co-investigators and study statistician until completion of comparative analysis. There will be no other blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years old) patients initiating ART
- •Adult (≥18 years old) patients already on ART and coming for ART re-prescribing
排除标准
- 未提供
研究组 & 干预措施
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.
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.
干预措施: Choice Architecture (Behavioral)
结局指标
主要结局
Percentage of Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation
时间窗: Up to 12 months
Comparing choice architecture and standard of care prescribing arms
次要结局
- Percentage of Established ART Patients Also Initiating TPT(Up to 12 months)
- Percentage of TPT-eligible Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation(Up to 12 months)
- Percentage of TPT-eligible Established ART Patients Also Initiating TPT(Up to 12 months)
- Percentage of Patients Started on TPT With Subsequent Discontinuation(Up to 12 months)
- Clinic Implementation of Choice Architecture as Assessed by Adoption(Up to 12 months)