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

Jillian L. Kadota, Allan Musinguzi, Juliet Nabunje, Fred Welishe, Jackie L. Ssemata, Opira Bishop, Christopher A. Berger, Devika Patel, Amanda Sammann, Anne Katahoire, Payam Nahid, Robert Belknap, Patrick P.J. Phillips, Jennifer Namusobya, Moses Kamya, Margaret A. Handley, Noah Kiwanuka, Achilles Katamba, David Dowdy, Fred C. SemitalaAdithya Cattamanchi

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number65
JournalImplementation Science
Volume15
Issue number1
DOIs
StatePublished - Aug 12 2020

Keywords

  • Effectiveness-implementation hybrid
  • HIV/AIDS
  • Isoniazid
  • Patient choice
  • Person-centered care
  • Preference trials
  • Rifapentine
  • Tuberculosis preventive therapy

ASJC Scopus subject areas

  • Health Policy
  • Health Informatics
  • Public Health, Environmental and Occupational Health

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