Browsing by Author "Kityamuwesi, Alex"
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Item 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, AdithyaPublic 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.Item Digital adherence technology for tuberculosis treatment supervision: a stepped-wedge cluster randomized trial(PLoS medicine, 2021) Cattamanchi, Adithya; Crowder, Rebecca; Kityamuwesi, Alex; Kiwanuka, Noah; Lamunu, Maureen; Namale, Catherine; Kunihira Tinka, Lynn; Sanyu Nakate, Agnes; Ggita, Joseph; Turimumahoro, Patricia; Babirye2, Diana; Oyuku, Denis; Berger, Christopher; Tucker, Austin; Patel, Devika; Sammann, Amanda; Stavia, Turyahabwe; Dowdy, David; Katamba, AchillesAdherence to and completion of tuberculosis (TB) treatment remain problematic in many high-burden countries. 99DOTS is a low-cost digital adherence technology that could increase TB treatment completion. Methods and findings We conducted a pragmatic stepped-wedge cluster-randomized trial including all adults treated for drug-susceptible pulmonary TB at 18 health facilities across Uganda over 8 months (1 December 2018–31 July 2019). Facilities were randomized to switch from routine (control period) to 99DOTS-based (intervention period) TB treatment supervision in consecutive months. Patients were allocated to the control or intervention period based on which facility they attended and their treatment start date. AU : IchangedPatientswereallocatedtothecontrolorinterventionperiodbasedontheirtreatmentstartdatetoPatientswereallocatedtothecontroloHealth facility staff and patients were not blinded to the intervention. The primary outcome was TB treatment completion. Due to the pragmatic nature of the trial, the primary analysis was done according to intention-to-treat (ITT) and per protocol (PP) principles. This trial is registered with the Pan African Clinical Trials Registry (PACTR201808609844917). Of 1,913 eligible patients at the 18 health facilities (1,022 and 891 during the control and intervention periods, respectively), 38.0% were women, mean (SD) age was 39.4 (14.4) years, 46.8% were HIV-infected, and most (91.4%) had newly diagnosed TB. In total, 463 (52.0%) patients were enrolled on 99DOTS during the intervention period. In the ITT analysis, the odds of treatment success were similar in the intervention and control periods (adjusted odds ratio [aOR] 1.04, 95% CI 0.68–1.58, p = 0.87). The odds of treatment success did not increase in the intervention period for either men (aOR 1.24, 95% CI 0.73–2.10) or women (aOR 0.67, 95% CI 0.35–1.29), or for either patients with HIV infection (aOR 1.51, 95% CI 0.81–2.85) or without HIV infection (aOR 0.78, 95% CI 0.46–1.32). In the PP analysis, the 99DOTS-based intervention increased the odds of treatment success (aOR 2.89, 95% CI 1.57–5.33, p = 0.001). The odds of completing the intensive phase of treatment and the odds of not being lost to follow-up were similarly improved in PP but not ITT analyses. Study limitations include the likelihood of selection bias in the PP analysis, inability to verify medication dosing in either arm, and incomplete implementation of some components of the intervention. Conclusions 99DOTS-based treatment supervision did not improve treatment outcomes in the overall study population. However, similar treatment outcomes were achieved during the control and intervention periods, and those patients enrolled on 99DOTS achieved high treatment completion. 99DOTS-based treatment supervision could be a viable alternative to directly observed therapy for a substantial proportion of patients with TB.Item Hepatitis B vaccination status and associated factors among undergraduate students of Makerere University College of Health Sciences(PLOS ONE, 2019) Wibabara, Yvette; Banura, Cecily; Kalyango, Joan; Karamagi, Charles; Kityamuwesi, Alex; Amia, Winfred Christine; Ocama, PonsianoHepatitis B is a global health problem. Trainees in the health-related fields are exposed to occupational risk of Hepatitis B Virus. In Uganda, there is scarcity of information on vaccination among students in health-care. The objective of this study was to assess hepatitis B vaccination status of the students and factors associated.Item Hepatitis B vaccination status and associated factors among undergraduate students of Makerere University College of Health Sciences(PLOS ONE, 2019-04-05) Wibabara, Yvette; Banura, Cecily,; Kalyango, Joan,; Karamagi, Charles,; Kityamuwesi, Alex; Amia, Winfred Christine; Ocama, PonsianoAbstract Background Hepatitis B is a global health problem. Trainees in the health-related fields are exposed to occupational risk of Hepatitis B Virus. In Uganda, there is scarcity of information on vaccination among students in health-care. The objective of this study was to assess hepatitis B vaccination status of the students and factors associated. Methods and findings This was a cross sectional study, conducted at Makerere University College of Health Sciences among undergraduate students who were eligible. A self-report on Hepatitis B vaccination status and various characteristics were collected on each participant, using a standardized structured self-administered questionnaire. Descriptive statistics were computed, bivariate and multivariate analysis were done using Stata 14. Results Out of 760 participants, 44.3% (95% CI 35.2–52.8) reported full vaccination. Vaccination was associated with gender, course, year of study and student’s sponsorship. Males were less likely to be vaccinated, Prevalence Ratio (PR) 0.79; P-value <0.001, while self-sponsored students were also most likely to be vaccinated, PR 2.08; P-value <0.001. About 37% reported an accidental needle injury during their training. Conclusion Full vaccination was low and given the high prevalence of needle injuries, it raises a safety concern. Vaccination should be mandatory for all students prior to clinical exposure. There is need for targeted interventions to increase uptake.Item Implementation, feasibility, and acceptability of 99DOTS-based supervision of treatment for drug- 2 susceptible TB in Uganda(medRxiv, 2022) Kiwanuka, Noah; Kityamuwesi, Alex; Crowder, Rebecca; Guzman, Kevin; Berger, Christopher A.; Lamunu, Maureen; Namale, Catherine; Kunihira Tinka, Lynn; Sanyu Nakate, Agnes; Ggita, Joseph; Turimumahoro, Patricia; Babirye, Diana; Oyuku, Denis; Patel, Devika; Sammann, Amanda; Stavia, Turyahabwe; Dowdy, David; Katamba, Achilles; Cattamanchi, Adithya99DOTS is a low-cost digital adherence technology that allows people with tuberculosis (TB) to self-report treatment adherence. There are limited data on its implementation, feasibility, and acceptability from sub-Saharan Africa. We conducted a longitudinal analysis and cross-sectional surveys nested within a stepped-wedge randomized trial at 18 health facilities in Uganda between December 2018 and January 2020. The longitudinal analysis assessed implementation of key components of a 99DOTS-based intervention, including self-reporting of TB medication adherence via toll-free phone calls, automated text message reminders and support actions by health workers monitoring adherence data. Cross-sectional surveys administered to a subset of people with TB and health workers assessed 99DOTS feasibility and acceptability. Composite scores for capability, opportunity, and motivation to use 99DOTS were estimated as mean Likert scale responses. Among 462 people with pulmonary TB enrolled on 99DOTS, median adherence was 58.4% (inter-quartile range [IQR] 38.7-75.6) as confirmed by self-reporting dosing via phone calls and 99.4% (IQR 96.4-100) when also including doses confirmed by health workers. Phone call-confirmed adherence declined over the treatment period and was lower among people with HIV (median 50.6% vs. 63.7%, p<0.001). People with TB received SMS dosing reminders on 90.5% of treatment days. Health worker support actions were documented for 261/409 (63.8%) people with TB who missed >3 consecutive doses. Surveys were completed by 83 people with TB and 22 health workers. Composite scores for capability, opportunity, and motivation were high; among people with TB, composite scores did not differ by gender or HIV status. Barriers to using 99DOTS included technical issues (phone access, charging, and network connection) and concerns regarding disclosure. 99DOTS was feasible to implement and highly acceptable to people with TB and their health workers. National TB Programs should offer 99DOTS as an option for TB treatment supervision.Item Is distance associated with tuberculosis treatment outcomes? A retrospective cohort study in Kampala, Uganda(BMC infectious diseases, 2020) Robsky, Katherine O.; Hughes, Seamus; Kityamuwesi, Alex; Kendall, Emily A.; Kitonsa, Peter James; Dowdy, David W.; Katamba, AchillesChallenges accessing nearby health facilities may be a barrier to initiating and completing tuberculosis (TB) treatment. We aimed to evaluate whether distance from residence to health facility chosen for treatment is associated with TB treatment outcomes. Methods: We conducted a retrospective cohort study of all patients initiating TB treatment at six health facilities in Kampala from 2014 to 2016. We investigated associations between distance to treating facility and unfavorable TB treatment outcomes (death, loss to follow up, or treatment failure) using multivariable Poisson regression. Results: Unfavorable treatment outcomes occurred in 20% (339/1691) of TB patients. The adjusted relative risk (aRR) for unfavorable treatment outcomes (compared to treatment success) was 0.87 (95% confidence interval [CI] 0.70, 1.07) for patients living ≥2 km from the facility compared to those living closer. When we separately compared each type of unfavorable treatment outcome to favorable outcomes, those living ≥2 km from the facility had increased risk of death (aRR 1.42 [95%CI 0.99, 2.03]) but decreased risk for loss to follow-up (aRR 0.57 [95%CI 0.41, 0.78]) than those living within 2 km. Conclusions: Distance from home residence to TB treatment facility is associated with increased risk of death but decreased risk of loss to follow up. Those who seek care further from home may have advanced disease, but once enrolled may be more likely to remain in treatment.Item Opportunities to improve digital adherence technologies and TB using human-centered design(The official journal of the International Union against Tuberculosis and Lung Disease, 2020) Berger, Christopher; Patel, Devika; Kityamuwesi, Alex; Ggita, Joseph; Kunihira Tinka, Lynn; Turimumahoro, Patricia; Neville, Katie; Chehab, Lara; Chen, Amy Z.; Gupta, Nakull; Turyahabwe, Stavia; Katamba, Achilles; Cattamanchi, Adithya; Sammann, AmandaDigital adherence technologies (DATs) have emerged as a promising solution for supporting and supervising patients being treated for tuberculosis (TB). Despite considerable enthusiasm and wide-scale implementation (1), few clinical trials and programmatic data have demonstrated improvement in treatment outcomes and shown variable uptake and engagement by patients and providers (2–6).Item Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion(BMJ Open, 2020) Crowder, Rebecca; Kityamuwesi, Alex; Kiwanuka, Noah; Lamunu, Maureen; Namale, Catherine; Kunihira Tinka, Lynn; Sanyu Nakate, Agnes; Ggita, Joseph; Turimumahoro, Patricia; Babirye, Diana; Oyuku, Denis; Allen Berger, Christopher; Tucker, Austin; Patel, Devika; Sammann, Amanda; Dowdy, David; Turyahabwe, Stavia,; Cattamanchi, Adithya; Katamba, AchillesLow-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The ‘DOT to DAT’ trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy. Methods and analysis This is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention. Ethics and dissemination Ethics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders.Item Variation in tuberculosis treatment outcomes and treatment supervision practices in Uganda(Journal of clinical tuberculosis and other mycobacterial diseases, 2020) Bergera, Christopher A.; Kityamuwesi, Alex; Crowder, Rebecca; Lamunu, Maureen; Kunihira Tinka, Lynn; Ggita, Joseph; Sanyu Nakate, Agnes; Namale, Catherine; Oyuku, Denis; Chenc, Katherine; Turyahabwe, Stavia; Cattamanchi, Adithya; Katamba, AchillesVariation in healthcare delivery is increasingly recognized as an important metric of healthcare quality. Directly observed therapy (DOT) has been the standard of care for tuberculosis (TB) treatment supervision for decades based on World Health Organization (WHO) guidelines. However, variation in implementation of DOT and associated TB treatment supervision practices remains poorly defined. Methods: We collected individual patient data from TB treatment registers at 18 TB treatment units in Uganda including District Health Centers, District Hospitals, and Regional Referral Hospitals. We also administered a survey and did observations of TB treatment supervision practices by health workers at each site. We describe variation in TB treatment outcomes and TB treatment supervision practices. Results: Of 2767 patients treated for TB across the 18 clinical sites between January 1 and December 31, 2017, 1740 (62.9%) were men, most were of working age (median 35 years, interquartile range [IQR] 27 – 46), 2546 (92.0%) had a new TB diagnosis, and nearly half (45.9%, n = 1283) were HIV positive. The pooled treatment success proportion was 69.4% (95% confidence interval [CI] 67.8 – 71.1) but there was substantial variation across sites (range 42.6 – 87.6%, I-squared 92.7%, p < 0.001). The survey and observation of TB treatment practices revealed that the majority of sites practice community-based DOT (66.7%, n = 12) and request a family member, who receives no additional training or supervision, to serve as a treatment supporter (77.8%, n = 14). At TB medication refill visits, all sites screen for side effects and most assess adherence via self-report (83.3%, n = 15). Only 7 (38.9%) sites followed-up patients who missed appointments using either phone calls (22.2%, n = 4/7) or community health workers (16.7%, n = 3/7). All 18 sites counseled patients at treatment initiation, but none provided additional counseling at refill visits other than addressing poor adherence or missed appointments. Conclusion: There was substantial variation in implementation of DOT, including observation and documentation of daily dosing, training and supervision of treatment supporters, and follow-up for missed clinic visits. Identifying best practices and reducing uncontrolled variation in the delivery of TB treatment is critical to improving treatment outcomes.