Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on directly observed therapy: non-inferiority randomized controlled trial

Trials

Study Protocol

Christine Sekaggya-Wiltshire¹  Stella Zawedde Muyanja¹  Ivan Lume¹  Clara Wekesa¹  Maria Sarah Nabaggala¹  Rosalind Parkes-Ratanshi²  Susan Adakun Akello³ 

[1] Infectious Diseases Institute, Makerere University, Kampala, Uganda;Infectious Diseases Institute, Makerere University, Kampala, Uganda;Department of Public Health, Cambridge University, Cambridge, UK;TB unit, Mulago National Referral Hospital, Kampala, Uganda;

关键词: Multi-drug-resistant tuberculosis;    Medication events monitoring system technology;    Directly observed therapy;    Differentiated care;    TB treatment adherence;    TB treatment outcomes;    Resource-limited settings;    Sub-Saharan Africa;    TB drug PK levels;   

DOI  :  10.1186/s13063-023-07314-z

 received in 2022-12-09, accepted in 2023-04-17,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAdherence is key to the treatment success of multi-drug resistant tuberculosis (MDR-TB) and prevention of community transmission. Directly observed therapy (DOT) is the recommended approach for the management of patients with MDR-TB. Uganda implements a health facility-based DOT approach where all patients diagnosed with MDR-TB report to the nearest private or public health facility for daily observation of ingesting their medicines by a health care provider. Directly observed therapy is very costly for both the patient and health care system. It follows the assumption that MDR TB patients have a history of poor adherence to TB treatment. But only 21% of MDR-TB patients notified globally and 1.4–12% notified in Uganda had been previously treated for TB. The shift to all oral treatment regimen for MDR-TB provides an opportunity for the exploration of self-administered therapy for this group of patients even with use of remotely operated adherence technology. We are conducting a non-inferiority open-label randomized controlled trial to compare adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) with a control group on DOT.MethodsWe plan to enrol 164 newly diagnosed MDR-TB patients aged ≥ 8 years from three regional hospitals based in rural and urban Uganda. Patients with conditions that affect their dexterity and ability to operate the MEMS-operated medicine equipment will not be eligible to participate in the trial. Patients are randomized to either of the two study arms: self-administered therapy with adherence being monitored using MEMS technology (intervention arm) or health facility-based DOT (control arm) and will be followed up monthly. Adherence is measured by the number of days the medicine bottle is open to access medication as recorded by the MEMS software in the intervention arm and treatment complaint days as recorded in the TB treatment card in the control arm. The primary outcome is the comparison of adherence rates between the two study arms.DiscussionThe evaluation of self-administered therapy for patients with MDR-TB is important to inform cost-effective management strategies for these patients. The approval of all oral regimens for the treatment of MDR-TB provides an opportunity for innovations such as MEMS technology to support sustainable options for MDR-TB treatment adherence support in low-resource settings.Trial registrationPan African Clinical Trials Registry, Cochrane #PACTR202205876377808. Retrospectively registered on 13 May 2022

【 授权许可】

CC BY   
© The Author(s) 2023

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