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
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Date
2020
Journal Title
Journal ISSN
Volume Title
Publisher
Implementation Science
Abstract
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 effectivenessimplementation
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 costeffectiveness
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.
Description
Keywords
Effectiveness-implementation hybrid, Tuberculosis preventive therapy, HIV/AIDS, Personcentered care
Citation
Kadota, J. L., Musinguzi, A., Nabunje, J., Welishe, F., Ssemata, J. L., Bishop, O., ... & Cattamanchi, A. (2020). 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. Implementation Science, 15(1), 1-12. https://doi.org/10.1186/s13012-020-01025-8