Browsing by Author "Kadota, Jillian L."

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    Completion of isoniazid–rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness–implementation randomized trial
    (PLoS Med, 2021) Semitala, Fred C.; Kadota, Jillian L.; Musinguzi, Allan; Nabunje, Juliet; Welishe, Fred; Nakitende, Anne; Akello, Lydia; Kamya, Moses R.; Handley, Margaret A.; Katahoire, Anne; Berger, Christopher A.; Kiwanuka, Noah; Katamba, Achilles; Dowdy, David W.; Cattamanchi, Adithya
    Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid–rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization’s (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. Methods and findings The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness–implementation randomized trial comparing 3 optimized strategies for delivering 3HP—facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid—to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (�11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. Conclusions 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion.
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    Patient Perspectives and Willingness to Accept Incentives for Tuberculosis Diagnostic Evaluation in Uganda
    (Value in Health Regional Issues, 2021) Kadota, Jillian L.; Nabwire, Sarah; Nalugwa, Talemwa; White, Justin S.; Cattamanchi, Adithya; Katamba, Achilles; Shete, Priya B.
    We assessed attitudes and perceptions and willingness to accept (WTA) varying incentive structures for completing tuberculosis (TB) diagnostic evaluation among patients in Uganda. Methods:We surveyed 177 adult patients undergoing TB evaluation at 10 health centers between September 2018 and March 2019. We collected household sociodemographic information and assessed attitudes and perceptions of incentives. We surveyed patients regarding their willingness to complete TB diagnostic evaluation in exchange for incentives ranging in value from 500 Ugandan shillings (USh) to 25 000USh (~$0.15-$6.75). We compared associations between WTA and patient characteristics using ordered logistic regression. Results: Participant willingness to return to the health center to complete TB diagnostic evaluation increased proportionally with incentive amount. The median participant accepted between 2000 and 5000 USh. Cash (52%) and transportation vouchers (34%) were the most popular incentive types. Half of respondents preferred unconditional incentives; for a multiday evaluation, 84% preferred conditioning incentive receipt upon returning to the health center. In multivariate models, we found the pairwise difference between the third and lowest income quartile (aOR = 2.38, 95% CI: 1.20-4.69; P = .01), younger age, and difficulty returning to the health center to be significantly associated with WTA higher incentive thresholds. Conclusions: In Uganda, incentives such as cash transfers or transportation vouchers are an acceptable intervention for facilitating adherence to TB diagnostic evaluation. Household income is associated with preferred incentive structure and amount, especially for those at the cusp of the poverty threshold who are more likely to prefer unconditional and higher valued incentives. Targeted and context-specific socioeconomic supports for at-risk patients are needed to optimize outcomes.
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    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, 2020) 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
    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.