Robin E Huebner
$207,582
University of Washington
Washington
National Institute of Allergy and Infectious Diseases (NIAID)
International and South African guidelines recommend TB preventive therapy (TPT) for people with HIV (PWH) and other people at high risk for TB, including close contacts of people with TB. Despite the evidence for reduced morbidity and mortality for people with HIV (PWH) who receive TPT, and guidelines recommending use, there remains a substantial gap between people recommended to receive and people who actually receive and complete a course of TPT. The 2022 WHO Global TB Report highlighted the growing gap in access and provision of TPT, which has been aggravated by the COVID-19 pandemic. Bridging this gap is a South African and global priority. With the recent availability and evidence for newer, shorter regimens of TPT, a transformation of HIV care delivery models (in part forced by the COVID-19 pandemic) and evolving national guidelines for TPT, it is increasingly urgent to explore new patient-friendly models of TPT delivery in order to inform programmatic guidance that results in greater uptake, adherence, and completion of TPT. HIV care has benefited from the expansion of “differentiated care delivery” models, which encourage community-delivered care, infrequent clinic/facility visits, limited laboratory monitoring, and task-shifted treatment models to deliver comprehensive HIV care to stable adults in community settings. Emerging demonstration projects have found that HIV preventive medication, or PrEP, can be safely and effectively delivered by pharmacists rather than clinicians. These successful models for differentiated HIV treatment and prevention delivery may be able to be translated to include TB preventive therapy. The availability of safe, effective, short-course TB preventive therapy with limited monitoring requirements suggests that similar community-based models may be adapted to provide this similarly essential preventive treatment. We will explore two approaches of adapting HIV differentiated services to TB prevention. We hypothesize that people who receive community-delivered TPT have higher rates of completion of a course of TPT than people who receive standard-of-care clinic-based TPT. We will conduct a randomized controlled trial of community vs. clinic-based TPT delivery among people participating in a community-based TB screening program in South Africa, and explore participant reasons for completion and noncompletion with qualitative research. We will also conduct preliminary research on the feasibility and acceptability of task-shifted TPT delivery, engaging clinic- based pharmacy assistants to provide TPT to low-risk clients. Through formative research, qualitative interviews with nurses, clinic operational managers, and workflow mapping exercises, we will identify barriers and facilitators for pharmacy assistant task-shifted TPT delivery. Together, this research will establish the foundation for subsequent larger trials of patient-centered, differentiated TPT delivery approaches to increase TPT uptake and completion in South Africa and ultimately decrease morbidity and mortality from TB.