Browsing by Author "Nakaweesa, Annet"

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    Design and execution of a public randomization ceremony to enhance stakeholder engagement within a cluster randomized trial to improve tuberculosis diagnosis in Uganda
    (Contemporary clinical trials communications, 2021) Reza, Tania F.; Nalugwa, Talemwa; Nantale, Mariam; Adams, Katherine; Fielding, Katherine; Nakaweesa, Annet; Oyuku, Denis; Nabwire, Sarah; Musinguzi, Johnson; Ojok, Christopher; Babirye, Diana; Ackerman, Sara L.; Handley, Margaret A.; Kityamuwesi, Alex; Dowdy, David W.; Moore, David A.J.; Davis, J. Lucian; Turyahabwe, Stavia; Katamba, Achilles; Cattamanch, Adithya
    Public randomization ceremonies have been proposed as a strategy to strengthen stakeholder engagement and address concerns and misconceptions associated with trial randomization. However, there are few published examples that describe how to conduct a public randomization ceremony with meaningful stakeholder engagement or how such ceremonies impact stakeholder perceptions about randomization and the randomization process. Cluster randomization for the GeneXpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial was conducted at a public randomization ceremony attended by 70 stakeholders in Kampala, Uganda. Presentations given by the Acting Assistant Commissioner from the Uganda National Tuberculosis and Leprosy Programme and trial investigators emphasized how the trial aimed to further national TB goals, as well as how stakeholders contributed to the intervention design. The purpose and process of randomization were described using simple text and visuals. Randomization was an interactive activity that required participation of stakeholders from each trial site. A survey administered to stakeholders at the end of the ceremony suggested high comprehension of randomization (98%), trust in the randomization process (96%), and satisfaction with randomization outcomes (96%). Public randomization ceremonies should be considered more routinely to engage stakeholders in and address potential concerns about the fairness and impartiality of the randomization process for community-based trials.
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    New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics
    (Clinical Infectious Diseases, 2024-02-02) Steadman, Amy; Andama, Alfred; Ball, Alexey; Mukwatamundu, Job; Khimani, Khushboo;; Mochizuki, Tessa; Asege, Lucy; Bukirwa, Alice; Kato, John Baptist; Katumba, David; Kisakye, Esther; Mangeni, Wilson; Mwebe, Sandra; Nakaye, Martha; Nassuna, Irene; Nyawere, Justine; Nakaweesa, Annet; Cook, Catherine; Phillips, Patrick; Nalugwa, Talemwa; Bachman, Christine M; Semitala, Fred Collins; Weigl, Bernhard H; Connelly, John; Worodria, William; Cattamanchi, Adithya
    BACKGROUNDSputum-based testing is a barrier to increasing access to molecular diagnostics for tuberculosis (TB). Many people with TB are unable to produce sputum, and sputum processing increases assay complexity and cost. Tongue swabs are emerging as an alternative to sputum, but performance limits are uncertain.METHODSFrom June 2022 to July 2023, we enrolled 397 consecutive adults with cough >2 weeks at 2 health centers in Kampala, Uganda. We collected demographic and clinical information, sputum for TB testing (Xpert MTB/RIF Ultra and 2 liquid cultures), and tongue swabs for same-day quantitative polymerase chain reaction (qPCR) testing. We evaluated tongue swab qPCR diagnostic accuracy versus sputum TB test results, quantified TB targets per swab, assessed the impact of serial swabbing, and compared 2 swab types (Copan FLOQSWAB and Steripack spun polyester).RESULTSAmong 397 participants, 43.1% were female, median age was 33 years, 23.5% were diagnosed with human immunodeficiency virus, and 32.0% had confirmed TB. Sputum Xpert Ultra and tongue swab qPCR results were concordant for 98.2% (95% confidence interval [CI]: 96.2-99.1) of participants. Tongue swab qPCR sensitivity was 92.6% (95% CI: 86.5 to 96.0) and specificity was 99.1% (95% CI: 96.9 to 99.8) versus microbiological reference standard. A single tongue swab recovered a 7-log range of TB copies, with a decreasing recovery trend among 4 serial swabs. Swab types performed equivalently.CONCLUSIONSTongue swabs are a promising alternative to sputum for molecular diagnosis of TB, with sensitivity approaching sputum-based molecular tests. Our results provide valuable insights for developing successful tongue swab-based TB diagnostics. MEDLINE - Academic