دورية أكاديمية
Comparison of 3 optimized delivery strategies for completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV in Uganda: A single-center randomized trial.
| العنوان: | Comparison of 3 optimized delivery strategies for completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV in Uganda: A single-center randomized trial. |
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| المؤلفون: | Semitala FC; Makerere University, Department of Medicine, College of Health Sciences, Kampala, Uganda.; Infectious Diseases Research Collaboration, Kampala, Uganda.; Makerere University Joint AIDS Program, Kampala Uganda., Kadota JL; Center for Tuberculosis, University of California San Francisco, San Francisco, California, United States of America.; Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America., Musinguzi A; Infectious Diseases Research Collaboration, Kampala, Uganda., Welishe F; Infectious Diseases Research Collaboration, Kampala, Uganda., Nakitende A; Infectious Diseases Research Collaboration, Kampala, Uganda., Akello L; Infectious Diseases Research Collaboration, Kampala, Uganda., Kunihira Tinka L; Infectious Diseases Research Collaboration, Kampala, Uganda., Nakimuli J; Infectious Diseases Research Collaboration, Kampala, Uganda., Ritar Kasidi J; Infectious Diseases Research Collaboration, Kampala, Uganda., Bishop O; Infectious Diseases Research Collaboration, Kampala, Uganda., Nakasendwa S; Department of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda., Baik Y; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America., Patel D; The Better Lab and Department of Surgery, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America., Sammann A; The Better Lab and Department of Surgery, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America., Nahid P; Center for Tuberculosis, University of California San Francisco, San Francisco, California, United States of America.; Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America., Belknap R; Denver Health and Hospital Authority and Division of Infectious Diseases, Department of Medicine, University of Colorado, Denver, Colorado, United States of America., Kamya MR; Makerere University, Department of Medicine, College of Health Sciences, Kampala, Uganda.; Infectious Diseases Research Collaboration, Kampala, Uganda., Handley MA; Center for Vulnerable Populations, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America.; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, United States of America., Phillips PP; Center for Tuberculosis, University of California San Francisco, San Francisco, California, United States of America.; Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America., Katahoire A; Child Health and Development Center, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda., Berger CA; Center for Tuberculosis, University of California San Francisco, San Francisco, California, United States of America.; Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America., Kiwanuka N; Department of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda., Katamba A; Clinical Epidemiology & Biostatistics Unit, Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Dowdy DW; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America., Cattamanchi A; Center for Tuberculosis, University of California San Francisco, San Francisco, California, United States of America.; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.; Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Irvine, California, United States of America. |
| المصدر: | PLoS medicine [PLoS Med] 2024 Feb 20; Vol. 21 (2), pp. e1004356. Date of Electronic Publication: 2024 Feb 20 (Print Publication: 2024). |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101231360 Publication Model: eCollection Cited Medium: Internet ISSN: 1549-1676 (Electronic) Linking ISSN: 15491277 NLM ISO Abbreviation: PLoS Med Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: San Francisco, CA : Public Library of Science, [2004]- |
| مواضيع طبية MeSH: | Tuberculosis*/drug therapy , Tuberculosis*/prevention & control , Latent Tuberculosis*/drug therapy , HIV Infections*/complications , HIV Infections*/drug therapy, Rifampin/*analogs & derivatives, Humans ; Isoniazid/adverse effects ; Antitubercular Agents/adverse effects ; Uganda ; Drug Therapy, Combination |
| مستخلص: | Background: Expanding access to shorter regimens for tuberculosis (TB) prevention, such as once-weekly isoniazid and rifapentine taken for 3 months (3HP), is critical for reducing global TB burden among people living with HIV (PLHIV). Our coprimary hypotheses were that high levels of acceptance and completion of 3HP could be achieved with delivery strategies optimized to overcome well-contextualized barriers and that 3HP acceptance and completion would be highest when PLHIV were provided an informed choice between delivery strategies. Methods and Findings: In a pragmatic, single-center, 3-arm, parallel-group randomized trial, PLHIV receiving care at a large urban HIV clinic in Kampala, Uganda, were randomly assigned (1:1:1) to receive 3HP by facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between facilitated DOT and facilitated SAT using a shared decision-making aid. We assessed the primary outcome of acceptance and completion (≥11 of 12 doses of 3HP) within 16 weeks of treatment initiation using proportions with exact binomial confidence intervals (CIs). We compared proportions between arms using Fisher's exact test (two-sided α = 0.025). Trial investigators were blinded to primary and secondary outcomes by study arm. Between July 13, 2020, and July 8, 2022, 1,656 PLHIV underwent randomization, with equal numbers allocated to each study arm. One participant was erroneously enrolled a second time and was excluded in the primary intention-to-treat analysis. Among the remaining 1,655 participants, the proportion who accepted and completed 3HP exceeded the prespecified 80% target in the DOT (0.94; 97.5% CI [0.91, 0.96] p < 0.001), SAT (0.92; 97.5% CI [0.89, 0.94] p < 0.001), and Choice (0.93; 97.5% CI [0.91, 0.96] p < 0.001) arms. There was no difference in acceptance and completion between any 2 arms overall or in prespecified subgroup analyses based on sex, age, time on antiretroviral therapy, and history of prior treatment for TB or TB infection. Only 14 (0.8%) participants experienced an adverse event prompting discontinuation of 3HP. The main limitation of the study is that it was conducted in a single center. Multicenter studies are now needed to confirm the feasibility and generalizability of the facilitated 3HP delivery strategies in other settings. Conclusions: Short-course TB preventive treatment was widely accepted by PLHIV in Uganda, and very high levels of treatment completion were achieved in a programmatic setting with delivery strategies tailored to address known barriers. Trial Registration: ClinicalTrials.gov NCT03934931. Competing Interests: A.S. and D.P. are human-centered design consultants for The Empathy Studio, LLC. D.P. is a human-centered design consultant for the Diversity Innovation Hub at Mt. Sinai. The other authors have declared that no competing interests exist. (Copyright: © 2024 Semitala et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) |
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| معلومات مُعتمدة: | R01 HL144406 United States HL NHLBI NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03934931 |
| المشرفين على المادة: | V83O1VOZ8L (Isoniazid) XJM390A33U (rifapentine) 0 (Antitubercular Agents) VJT6J7R4TR (Rifampin) |
| تواريخ الأحداث: | Date Created: 20240220 Date Completed: 20240306 Latest Revision: 20240307 |
| رمز التحديث: | 20240307 |
| مُعرف محوري في PubMed: | PMC10914279 |
| DOI: | 10.1371/journal.pmed.1004356 |
| PMID: | 38377166 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1549-1676 |
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| DOI: | 10.1371/journal.pmed.1004356 |