ABSTRACT
Nigeria adopted Seasonal Malaria Chemoprevention (SMC) for children under 5 years of age as part of national malaria control policies, in 2014. By 2021 the intervention was being implemented in 18 states, delivered over 4 months between June and October by 143,000 community drug distributors (CDDs) to a target population of 23.1million children. Further expansion of SMC is planned, extending to 21 states in 2022 with a target population of 27.1 million children, and an increased number of monthly cycles, from 4 to 5, may be needed in some states. In view of this massive scale-up of SMC, the National Malaria Elimination Programme conducted a qualitative research study shortly after the 2021 campaign to understand community attitudes to SMC, and to identify barriers to uptake and facilitating factors, in order to ensure that community perspectives inform future planning of SMC delivery in Nigeria. In each of five states (Kano, Kwara, Nasarawa, Yobe and Kebbi), Local Government Areas (LGAs) were ranked based on administrative coverage of SMC in 2021, and one LGA with high coverage and one with low coverage selected. In two wards (one urban and one rural) in each LGA, focus group discussions (FGDs) were held with caregivers, and in-depth interviews (IDIs) were conducted with community leaders and with community drug distributors. State-level and LGA malaria focal persons were also interviewed. At national level, key-informant interviews (KIIs) were held with the NMEP coordinator, and representatives of partners working on SMC in Nigeria. Interviews were recorded and transcribed, and those in local languages translated into English, and the transcripts were analysed using NVivo software. A total of 190 FGDs, KIIs and IDIs were undertaken. In all study areas malaria was seen as a major health concern and SMC was widely accepted as a key preventive measure, and community drug distributors (CDDs) were generally trusted. Caregivers preferred SMC delivered door-to-door to the fixed-point approach, because in addition to allowing them to continue daily tasks, door-to-door delivery allowed more time for the CDD to explain how to administer the treatments and advise about adverse reactions and to answer questions. Barriers identified included perceived side effects of SMC drugs, a lack of understanding of the purpose of SMC, mistrust and suspicions that medicines provided free may be unsafe or ineffective. Key informants and caregivers reported SMC distributions limited by drug shortages, supplies running out before all children in the community had been treated. Key findings from this study were shared with delivery teams during national and state level training in 2022 and through cascade training to all community drug distributors and others involved in SMC campaigns. Other steps to act on the findings will include updating the training curriculum to show SMC teams how to strengthen communication to caregivers on the importance, safety and effectiveness of SMC, during campaigns; more involvement of state and national level pharmacovigilance coordinators during implementation to improve completion and submission of individual case safety reports and investigation of suspected adverse drug reactions. To avoid local shortages of SMC drugs, NMEP will ensure stricter adherence to the planned medicine allocations for each facility based on microplanning estimates. Study findings were shared with donors and implementing partners, to reinforce the importance of retaining primarily door-to-door delivery of SMC in Nigeria.
Subject(s)
MalariaABSTRACT
Background: Globally rifampicin-resistant tuberculosis disease affects around 460 000 people each year. Current recommended regimens are 9-24 months duration, have poor efficacy and carry significant toxicity. A shorter, less toxic and more efficacious regimen would improve outcomes for people with rifampicin-resistant tuberculosis. MethodsTB-PRACTECAL is an open-label, randomised, controlled, phase II/III non-inferiority trial evaluating the safety and efficacy of 24 week regimens containing bedaquiline and pretomanid to treat rifampicin resistant tuberculosis. Conducted in Uzbekistan, South Africa and Belarus, patients aged 15 and above with rifampicin resistant pulmonary tuberculosis and requiring a new course of therapy are eligible for inclusion irrespective of HIV status. In the first stage, equivalent to a phase IIB trial, patients are randomly assigned one of four regimens, stratified by site. Investigational regimens include oral bedaquiline, pretomanid and linezolid. Additionally, two of the regimens also include moxifloxacin (arm 1) and clofazimine (arm 2) respectively. Treatment is administered under direct observation for 24 weeks in investigational arms and 36 to 96 weeks in the standard of care arm. The second stage of the study is equivalent to a phase III trial, investigating the safety and efficacy of the most promising regimen/s. The primary outcome is the percentage of unfavourable outcomes at 72 weeks post randomisation. This is a composite of early treatment discontinuation, treatment failure, recurrence, lost to follow up and death. The study is conducted in accordance with ICH-GCP and full ethical approval was obtained from Médecins sans Frontières ethical review board, London School of Hygiene and Tropical Medicine ethical review board as well as ERBs and regulatory authorities at each site. DiscussionTB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel regimens that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to end of recruitment and additionally, the planned final analysis at 72 weeks after end of recruitment. Trial registrationClinicaltrials.gov registration number NCT02589782