Browsing by Author "Tibenderana, James"

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    Challenges and Strategies for Conducting Clinical Research During the COVID-19 Pandemic: Experiences from Resource Limited Settings
    (European Journal of Clinical Medicine, 2021) Achan, Jane; Serwanga, Asadu; Aanyu, Hellen.T; Opigo, Jimmy; Kyagulanyi, Tonny; Nuwa, Anthony; Magumba, Godfrey; Nakwagala, Fredrick; Marasciulo, Madeleine; Hamade, Prudence; Tibenderana, James
    As COVID-19 disease surges across much of the world, researchers in different settings have a unique opportunity to address the various research priorities that have been identified. The challenges that containment and mitigation strategies present for research, especially in resource limited settings, could be significant and negatively impact the essential contribution of these settings to COVID-19 research.To describe experiences of conducting research during this pandemic, discuss challenges faced and present strategies implemented to address these challenges.Malaria Consortium recently initiated an observational case series study to assess the magnitude and clinical consequences of co-infection of COVID-19, malaria, and other common infections. This study is being conducted in eight COVID-19 treatment centres in Uganda. Qualitative methods including observations and interviews were utilized to document experiences and mitigating strategies for identified challenges. The main outcomes were a descriptive narrative of experiences conducting this research, discussion of challenges faced, and presentation of strategies implemented to address these challenges.Expedited ethical review and approval facilitated timely initiation of research activities. The primary clinical care teams at each treatment centre performed all study procedures to minimize infection. Given concerns about fomite transmission, considerations arose on how best to handle consent forms that had been signed or thumb-printed by patients to ensure that both hospital and research staff were not exposed to infection. Consenting severely ill or mentally impaired patients was also a challenge, especially when the next of kin was not available. Patient compensation was done through a mobile money/digital platform to avoid potential risks associated with cash. Patients, health care workers and study staff faced significant psychosocial challenges and anxiety that needed to be addressed.These experiences demonstrate that more adaptable and innovative approaches may be needed to support the implementation of research activities during this COVID-19 pandemic. This pandemic should also spur institutional review boards and investigators to respond to emerging challenges by updating policies and procedures around research review and approvals, and modifications in research methods.
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    Efficacy and safety of artemether‑lumefantrine and dihydroartemisinin‑piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria and prevalence of molecular markers associated with artemisinin and partner drug resistance in Uganda
    (Malaria Journal, 2022) Ebong, Chris; Sserwanga, Asadu; Frances Namuganga, Jane; Kapisi, James; Mpimbaza, Arthur; Gonahasa, Samuel; Asua, Victor; Gudoi, Sam; Kigozi, Ruth; Tibenderana, James; Bwanika, John Bosco; Bosco, Agaba; Rubahika, Denis; Kyabayinze, Daniel; Opigo, Jimmy; Rutazana, Damian; Sebikaari, Gloria; Belay, Kassahun; Niang, Mame; Halsey, Eric S.; Moriarty, Leah F.; Lucchi, Naomi W.; Svigel Souza, Samaly S.; Nsobya, Sam L.; Kamya, Moses R.; Yeka, Adoke
    In Uganda, artemether-lumefantrine (AL) is first-line therapy and dihydroartemisinin-piperaquine (DP) second-line therapy for the treatment of uncomplicated malaria. This study evaluated the efficacy and safety of AL and DP in the management of uncomplicated falciparum malaria and measured the prevalence of molecular markers of resistance in three sentinel sites in Uganda from 2018 to 2019. Methods: This was a randomized, open-label, phase IV clinical trial. Children aged 6 months to 10 years with uncomplicated falciparum malaria were randomly assigned to treatment with AL or DP and followed for 28 and 42 days, respectively. Genotyping was used to distinguish recrudescence from new infection, and a Bayesian algorithm was used to assign each treatment failure a posterior probability of recrudescence. For monitoring resistance, Pfk13 and Pfmdr1 genes were Sanger sequenced and plasmepsin-2 copy number was assessed by qPCR. Results: There were no early treatment failures. The uncorrected 28-day cumulative efficacy of AL ranged from 41.2 to 71.2% and the PCR-corrected cumulative 28-day efficacy of AL ranged from 87.2 to 94.4%. The uncorrected 28-day cumulative efficacy of DP ranged from 95.8 to 97.9% and the PCR-corrected cumulative 28-day efficacy of DP ranged from 98.9 to 100%. The uncorrected 42-day efficacy of DP ranged from 73.5 to 87.4% and the PCR-corrected 42-day efficacy of DP ranged from 92.1 to 97.5%. There were no reported serious adverse events associated with any of the regimens. No resistance-associated mutations in the Pfk13 gene were found in the successfully sequenced samples. In the AL arm, the NFD haplotype (N86Y, Y184F, D1246Y) was the predominant Pfmdr1 haplotype, present in 78 of 127 (61%) and 76 of 110 (69%) of the day 0 and day of failure samples, respectively. All the day 0 samples in the DP arm had one copy of the plasmepsin-2 gene. Conclusions: DP remains highly effective and safe for the treatment of uncomplicated malaria in Uganda. Recurrent infections with AL were common. In Busia and Arua, the 95% confidence interval for PCR-corrected AL efficacy fell below 90%. Further efficacy monitoring for AL, including pharmacokinetic studies, is recommended. Trial registration The trial was also registered with the Pan African Clinical Trial Registry (https:// pactr. samrc. ac. za/) with study Trial No. PACTR201811640750761.
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    Integrated community case management in a peri-urban setting: a qualitative evaluation in Wakiso District, Uganda
    (BMC health services research, 2017) Altaras, Robin; Montague, Mark; Graham, Kirstie; Strachan, Clare E.; Senyonjo, Laura; King, Rebecca; Counihan, Helen; Mubiru, Denis; Källander, Karin; Meek, Sylvia; Tibenderana, James
    Integrated community case management (iCCM) strategies aim to reach poor communities by providing timely access to treatment for malaria, pneumonia and diarrhoea for children under 5 years of age. Community health workers, known as Village Health Teams (VHTs) in Uganda, have been shown to be effective in hard-to-reach, underserved areas, but there is little evidence to support iCCM as an appropriate strategy in non-rural contexts. This study aimed to inform future iCCM implementation by exploring caregiver and VHT member perceptions of the value and effectiveness of iCCM in peri-urban settings in Uganda. Methods: A qualitative evaluation was conducted in seven villages in Wakiso district, a rapidly urbanising area in central Uganda. Villages were purposively selected, spanning a range of peri-urban settlements experiencing rapid population change. In each village, rapid appraisal activities were undertaken separately with purposively selected caregivers (n = 85) and all iCCM-trained VHT members (n = 14), providing platforms for group discussions. Fifteen key informant interviews were also conducted with community leaders and VHT members. Thematic analysis was based on the ‘Health Access Livelihoods Framework’. Results: iCCM was perceived to facilitate timely treatment access and improve child health in peri-urban settings, often supplanting private clinics and traditional healers as first point of care. Relative to other health service providers, caregivers valued VHTs’ free, proximal services, caring attitudes, perceived treatment quality, perceived competency and protocol use, and follow-up and referral services. VHT effectiveness was perceived to be restricted by inadequate diagnostics, limited newborn care, drug stockouts and VHT member absence – factors which drove utilisation of alternative providers. Low community engagement in VHT selection, lack of referral transport and poor availability of referral services also diminished perceived effectiveness. The iCCM strategy was widely perceived to result in economic savings and other livelihood benefits. Conclusions: In peri-urban areas, iCCM was perceived as an effective, well-utilised strategy, reflecting both VHT attributes and gaps in existing health services. Depending on health system resources and organisation, iCCM may be a useful transitional service delivery approach. Implementation in peri-urban areas should consider tailored community engagement strategies, adapted selection criteria, and assessment of population density to ensure sufficient coverage.