Browsing by Author "Fielding, Katherine"

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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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    Effectiveness and safety of misoprostol distributed to antenatal women to prevent postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial
    (BMC pregnancy and childbirth, 2015) Ononge, Sam; Campbell, Oona M. R.; Kaharuza, Frank; Lewis, James J.; Fielding, Katherine; Mirembe, Florence
    Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH. Methods: Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant. Results: 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2 %) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4 % vs intervention 91.4 %, mean difference = -11.0 %, 95 % confidence interval [CI] -25.7 % to 3.6 %, p = 0.11). No woman took misoprostol before their baby’s birth. Shivering and fever were 14.9 % in the control arm compared to 22.2 % in the intervention arm (mean difference = -7.2 %, 95 % CI -11.1 % to -3.7 %), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4 % in the intervention arm (mean difference = 7.1 %, 95% CI -3.1 % to 17.3 %, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6 % vs intervention 14.5 %, mean difference -4.9; 95 % CI -12.7 to 2.9), p = 0.17). Conclusion: This study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol. The study was registered with Pan-African Clinical Trials Network (PACTR201303000459148, on 19/11/2012).
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    Quality of care for patients evaluated for tuberculosis in the context of Xpert MTB/RIF scale-up
    (Journal of clinical tuberculosis and other mycobacterial diseases, 2019) Farra, Katherine; Nalugwa, Talemwa; Ojok, Christopher; Nantale, Mariam; Nabwire, Sarah; Oyuku, Denis; Shete, Priya B.; Han, Alvina H.; Fielding, Katherine; Joloba, Moses; Mugabe, Frank; Dowdy, David W.; Mooreh, DAJ; Davis, Lucian; Katamba, Achilles; Cattamanchi, Adithya
    Many high-burden countries are scaling-up Xpert MTB/RIF using a hub-and-spoke model. We evaluated the quality of care for patients undergoing TB evaluation at microscopy centers (spokes) linked to Xpert testing sites (hubs) in Uganda. Objectives: To characterize the extent to which patients were receiving care in accordance with international and national guidelines. Methods: We conducted a prospective cohort study of all adults with presumptive pulmonary TB at 24 health centers linked to Xpert testing sites. Health center staff photographed TB registers, and uploaded photos to a secure server bi-weekly. We assessed the proportion of patients (1) initiating testing; (2) completing testing; and (3) treated for confirmed TB within 14 days. Measurements and Main Results: Between January to December 2017, 6744 patients underwent evaluation for pulmonary TB. Only 1316 patients had sputum referred for Xpert testing, including 1075/3229 (33.3%) people living with HIV and 241/3515 (6.9%) without HIV. Of 119 patients confirmed to have TB by Xpert testing, 44 (36%) did not initiate treatment. There were significant losses along the entire diagnostic cascade of care, with only 5330/6744 (79.0%) patients having samples referred for sputum-based testing, 2978/5330 (55.9%) patients completing recommended testing if referred, and 313/418 (74.9%) patients initiating treatment within 14 days if confirmed to have TB. Conclusions: Although coverage of Xpert testing services across Uganda is high, the quality of care delivered to patients undergoing TB evaluation remains poor. Further research is needed to identify health system interventions to facilitate uptake of Xpert testing and high-quality care.