TY - JOUR
T1 - Protocol for the 3HP Options Trial
T2 - A hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda
AU - Kadota, Jillian L.
AU - Musinguzi, Allan
AU - Nabunje, Juliet
AU - Welishe, Fred
AU - Ssemata, Jackie L.
AU - Bishop, Opira
AU - Berger, Christopher A.
AU - Patel, Devika
AU - Sammann, Amanda
AU - Katahoire, Anne
AU - Nahid, Payam
AU - Belknap, Robert
AU - Phillips, Patrick P.J.
AU - Namusobya, Jennifer
AU - Kamya, Moses
AU - Handley, Margaret A.
AU - Kiwanuka, Noah
AU - Katamba, Achilles
AU - Dowdy, David
AU - Semitala, Fred C.
AU - Cattamanchi, Adithya
N1 - Publisher Copyright:
© 2020 The Author(s).
PY - 2020/8/12
Y1 - 2020/8/12
N2 - 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.
AB - 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.
KW - Effectiveness-implementation hybrid
KW - HIV/AIDS
KW - Isoniazid
KW - Patient choice
KW - Person-centered care
KW - Preference trials
KW - Rifapentine
KW - Tuberculosis preventive therapy
UR - http://www.scopus.com/inward/record.url?scp=85089611815&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85089611815&partnerID=8YFLogxK
U2 - 10.1186/s13012-020-01025-8
DO - 10.1186/s13012-020-01025-8
M3 - Article
C2 - 32787925
AN - SCOPUS:85089611815
SN - 1748-5908
VL - 15
JO - Implementation Science
JF - Implementation Science
IS - 1
M1 - 65
ER -