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Principal Investigator: ADRIENNE E SHAPIRO
Organization: UNIVERSITY OF WASHINGTON
Fiscal Year: 2024
Award: $168,574
Funding agency: National Institute of Allergy and Infectious Diseases
ABSTRACT
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.
Terms: <21+ years old><AIDS Virus><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Adherence><Adopted><Adult><Adult Human><Adverse effects><Blood Serum><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Cessation of life><Client><Clinic><Clinical><Communicable Diseases><Communities><Community Trial><Data><Death><Decentralization><Dose><Drug Resistance Tuberculosis><Drug Resistant TB><Drug Resistant Tuberculosis><Drug resistance in tuberculosis><Drugs><Effectiveness><Eligibility><Eligibility Determination><Exercise><Focus Groups><Foundations><Friends><Guidelines><HIV><Healthcare Delivery><Human Immunodeficiency Viruses><Incidence><Individual><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><International><Interview><Isonicotinic Acid Hydrazide><LAV-HTLV-III><Laboratories><Lymphadenopathy-Associated Virus><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MTB infection><Maps><Measures><Medication><Methods><Modeling><Monitor><Morbidity><Morbidity - disease rate><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><Nurses><Participant><Pathway interactions><Patient Self-Report><Patients><Persons><Pharmaceutical Preparations><Pharmacies><Pharmacists><Pharmacy facility><Population><PrEP><Preventative therapy><Preventative treatment><Prevention><Preventive><Preventive therapy><Preventive treatment><Protocol Screening><Public Sector><Qualitative Research><Randomized><Randomized, Controlled Trials><Recommendation><Regimen><Reporting><Research><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety><Schedule><Self-Report><Serum><Service delivery model><Service model><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><South Africa><South African><Survey Instrument><Surveys><System><TB diagnosis><TB drug resistance><TB infection><Therapeutic Studies><Therapy Research><Time><Toxic effect><Toxicities><Translating><Travel><Treatment Protocols><Treatment Regimen><Treatment Schedule><Triage><Tuberculosis><Tuberculosis diagnosis><Virus-HIV><Visit><World Health Organization><acceptability and feasibility><access gaps><adulthood><care delivery model><community setting><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><diagnosed with TB><diagnosed with Tuberculosis><disseminated TB><disseminated tuberculosis><drug resistance in TB><drug resistant in tuberculosis><drug/agent><experience><gaps in access><health and care delivery><health care delivery><health care delivery model><health delivery systems><health services delivery><healthcare delivery model><high risk><implementation science><implementation strategy><improved><infection due to Mycobacterium tuberculosis><innovate><innovation><innovative><intervention design><intervention refinement><isoniazid><mortality><nurse><participant interview><pathway><patient centered><patient oriented><pill><pre-exposure prophylaxis><prevent><preventable death><preventable mortality><preventing><programs><randomisation><randomization><randomized control trial><randomly assigned><response><rifapentine><scale up><screening><screening program><screenings><service delivery><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><standard of care><strategies for implementation><supply chain><therapy adherence><therapy compliance><therapy design><treatment design><trial comparing><tuberculosis infection><tuberculous spondyloarthropathy><uptake><willingness>