Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options Trial

University Of California-Irvine, Irvine CA

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY/ABSTRACT Tuberculosis preventive therapy (TPT) is known to reduce the incidence of tuberculosis (TB) among people living with HIV (PLHIV) and is considered a core service of National AIDS Programs. TPT coverage has been steadily increasing with the availability of short-course regimens such as 12 weeks of once-weekly isoniazid- rifapentine (3HP). However, treatment completion in programmatic settings remains sub-optimal, highlighting the need to identify feasible facilitation strategies that can maximize the impact of the considerable investments in TPT scale-up. Previously, in a single-center randomized trial in Uganda, we demonstrated that facilitated self-administered therapy (SAT) resulted in high levels (92%) of treatment completion, was preferred by most PLHIV and substantially reduced health system costs relative to directly observed therapy. Further evidence is now needed on whether the facilitation components are necessary and feasible to implement across a broad array of HIV clinics to guide TPT scale-up efforts. Building on our prior work, the overall objective of this proposal is to compare the effectiveness and implementation of simplified facilitated SAT to routine SAT for 3HP delivery. Simplified facilitation will include three components from our previous trial designed to address key barriers to 3HP completion: enhanced counseling, interactive voice response dosing reminders/adverse event check-ins, and 99DOTS-based adherence monitoring/support. Routine SAT will include enhanced counseling alone. Our central hypothesis is that simplified facilitated SAT will result in higher levels of completion than routine SAT and be cost-effective. In Aim 1, we will test our hypothesis by conducting a highly pragmatic cluster-randomized trial among 3400 PLHIV at 20 HIV clinics in three districts of Uganda to compare completion of 3HP using simplified facilitated SAT vs. routine SAT. The selected HIV clinics represent diverse levels of the healthcare system, geography (rural vs. urban/peri-urban location) and experience with 3HP delivery. In Aim 2, we will employ a mixed methods approach to assess the reach, adoption and implementation of facilitated SAT components, and whether or not they modified targeted barriers. Last, in Aim 3, we will collect data on the cost of simplified facilitation of 3HP from the health system and societal perspectives to estimate the incremental cost- effectiveness of simplified facilitated SAT as a function of key facility-level characteristics. Investments in scale-up of 3HP – the most promising intervention for TB prevention available today – will not achieve the desired impact unless 3HP can be delivered effectively and in a person-centered fashion. Our proposed studies will clearly demonstrate whether facilitation components are required to achieve high completion, feasible to implement across a variety of clinic settings, and cost-effective. These data will inform decisions as to whether simplified facilitation should be budgeted by HIV/AIDS programs as part of 3HP scale- up initiatives in high TB-burden settings throughout Africa and worldwide.