NDLI: Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda

Content Provider	Springer Nature : BioMed Central
Author	Kadota, Jillian L. Musinguzi, Allan Nabunje, Juliet Welishe, Fred Ssemata, Jackie L. Bishop, Opira Berger, Christopher A. Patel, Devika Sammann, Amanda Katahoire, Anne Nahid, Payam Belknap, Robert Phillips, Patrick P. J. Namusobya, Jennifer Kamya, Moses Handley, Margaret A. Kiwanuka, Noah Katamba, Achilles Dowdy, David Semitala, Fred C. Cattamanchi, Adithya
Abstract	Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931 ; Registered 2 May 2019.
Related Links	https://implementationscience.biomedcentral.com/counter/pdf/10.1186/s13012-020-01025-8.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
ISSN	17485908
DOI	10.1186/s13012-020-01025-8
Journal	Implementation Science
Issue Number	1
Volume Number	15
Language	English
Publisher	BioMed Central
Publisher Date	2020-08-12
Access Restriction	Open
Subject Keyword	Health Services Research Public Health Health Informatics Health Policy Health Administration Health Promotion and Disease Prevention Effectiveness-implementation hybrid Rifapentine Isoniazid Tuberculosis preventive therapy HIV/AIDS Person-centered care Patient choice Preference trials
Content Type	Text
Resource Type	Article
Subject	Health Policy Public Health, Environmental and Occupational Health Health Informatics
Journal Impact Factor	8.8/2023
5-Year Journal Impact Factor	9.2/2023

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