Lessons from the first clinical trial of a non-licensed vaccine among Ugandan adolescents: a phase II field trial of the tuberculosis candidate vaccine, MVA85A

Background: A more effective vaccine for tuberculosis (TB) is a global public health priority. Vaccines under development will always need evaluation in endemic settings, most of which have limited resources. Adolescents are an important target population for a new TB vaccine and for other vaccines which are relevant at school-age. However, in most endemic settings there is limited experience of trials of investigational products among adolescents, and adolescents are not routinely vaccinated. Methods: We used Modified vaccinia Ankara-expressing Ag85A (MVA85A), a well-tolerated candidate vaccine for tuberculosis, to assess the effect of Schistosoma mansoni infection on vaccine immunogenicity among Ugandan adolescents in primary school. We describe here the challenges and lessons learned in designing and implementing this first clinical trial among Ugandan adolescents using a non-licensed vaccine. Results: The school based immunization study was feasible and adhered to Good Clinical Practice principles.  Engagement with the community and all stakeholders was critical for successful implementation of the trial. Creative and adaptable strategies were used to address protocol-specific, operational and logistical challenges. This study provided lessons and solutions that can be applied to other trials among adolescents in similar settings elsewhere, and to school-based immunization programs. Conclusion: Sufficient time and resources should be planned for community preparation and sensitization to ensure buy in and acceptance of a project of this kind. This trial shows that challenges to implementing early field trials in Africa are not insurmountable and that necessary well-planned high-quality ethical trials are feasible and should be encouraged. Trial Registration: ClinicalTrials.gov NCT02178748 03/06/201

Estimating the effects of COVID-19 on essential health services utilization in Uganda and Bangladesh using data from routine health information systems

Background Since March 2020, the coronavirus disease 2019 (COVID-19) pandemic has been a major shock to health systems across the world. We examined national usage patterns for selected basic, essential health services, before and during the COVID-19 pandemic in Uganda and Bangladesh, to determine whether COVID-19 affected reporting of service utilization and the use of health services in each country. Methods We used routine health information system data since January 2017 to analyze reporting and service utilization patterns for a variety of health services. Using time series models to replicate pre-COVID-19 trajectories over time we estimated what levels would have been observed if COVID-19 had not occurred during the pandemic months, starting in March 2020. The difference between the observed and predicted levels is the COVID-19 effect on health services. Results The time trend models for Uganda and Bangladesh closely replicated the levels and trajectories of service utilization during the 38 months prior to the COVID-19 pandemic. Our results indicate that COVID-19 had severe effects across all services, particularly during the first months of the pandemic, but COVID-19 impacts on health services and subsequent recovery varied by service type. In general, recovery to expected levels was slow and incomplete across the most affected services. Conclusion Our analytical approach based on national information system data could be very useful as a form of surveillance for health services disruptions from any cause leading to rapid responses from health service managers and policymakers

Estimating the effects of COVID-19 on essential health services utilization in Uganda and Bangladesh using data from routine health information systems

BackgroundSince March 2020, the coronavirus disease 2019 (COVID-19) pandemic has been a major shock to health systems across the world. We examined national usage patterns for selected basic, essential health services, before and during the COVID-19 pandemic in Uganda and Bangladesh, to determine whether COVID-19 affected reporting of service utilization and the use of health services in each country.MethodsWe used routine health information system data since January 2017 to analyze reporting and service utilization patterns for a variety of health services. Using time series models to replicate pre-COVID-19 trajectories over time we estimated what levels would have been observed if COVID-19 had not occurred during the pandemic months, starting in March 2020. The difference between the observed and predicted levels is the COVID-19 effect on health services.ResultsThe time trend models for Uganda and Bangladesh closely replicated the levels and trajectories of service utilization during the 38 months prior to the COVID-19 pandemic. Our results indicate that COVID-19 had severe effects across all services, particularly during the first months of the pandemic, but COVID-19 impacts on health services and subsequent recovery varied by service type. In general, recovery to expected levels was slow and incomplete across the most affected services.ConclusionOur analytical approach based on national information system data could be very useful as a form of surveillance for health services disruptions from any cause leading to rapid responses from health service managers and policymakers

Association between Prior Chlamydia trachomatis Infection and Ectopic Pregnancy at a Tertiary Care Hospital in South Western Uganda

Background. Increase in the number of ectopic pregnancy is attributed to increase in the incidence of pelvic infections. Chlamydia trachomatis is responsible for most of the sexually transmitted bacterial infections. If undetected and untreated, the infection can ascend to the upper genital tract and cause pelvic inflammatory disease (PID) and related sequelae (ectopic pregnancy and tubal factor infertility). Objective. To determine the association between prior Chlamydia trachomatis infection and ectopic pregnancy at Mbarara Regional Referral Hospital (MRRH). Methods. This was an unmatched case-control study carried out at MRRH involving 25 cases and 76 controls. Serological evidence of prior chlamydial infection was determined by testing for the presence of Chlamydia immunoglobulin G antibodies in their blood. Logistic regression was used to determine the association between prior Chlamydia trachomatis infection and also the factors associated with ectopic pregnancy. The significant level of <0.05 was used. Results. Chlamydia antibodies were found in 60% of patients with ectopic pregnancy and 26.3% of the controls (p=0.002). The presence of Chlamydia antibodies was associated with a fourfold risk of ectopic pregnancy. Conclusion. There was a strong association between prior Chlamydia trachomatis infection and ectopic pregnancy

Prevalence and Factors Associated with Hydatidiform Mole among Patients Undergoing Uterine Evacuation at Mbarara Regional Referral Hospital

Objective. We sought to determine the prevalence of and factors associated with hydatidiform molar gestations amongst patients undergoing uterine evacuation at Mbarara Regional Referral Hospital (MRRH), Mbarara, Uganda. Methods. This was a cross-sectional study carried out from November 2016 to February 2017. All patients admitted for uterine evacuation for nonviable pregnancy were included. The study registered 181 patients. Data were collected on sociodemographics, medical conditions, obstetrics, and gynecological factors. The evacuated tissue received a full gross and histopathologic examination. Cases of pathologically suspected complete hydatidiform mole were confirmed by p57 immunohistochemistry. Data were analyzed using STATA 13. Results. The prevalence of hydatidiform mole was 6.1% (11/181). All detected moles were complete hydatidiform moles, and there were no diagnosed partial hydatidiform moles. Clinical diagnosis of molar pregnancy was suspected in 13 patients, but only 69.2% (9/13) were confirmed as molar pregnancies histologically. Two cases were clinically unsuspected. Factors that had a significant relationship with complete hydatidiform mole included maternal age of 35 years and above (aOR 13.5; CI: 1.46–125.31; p=0.00), gestational age beyond the first trimester at the time of uterine evacuation (aOR 6.2; CI: 1.07–36.14; p=0.04), and history of previous abortion (aOR 4.3; CI: 1.00–18.57; p=0.05). Conclusion. The prevalence of complete hydatidiform mole was high at 6.1%. Associated risk factors included advanced maternal age (35 years and above), history of previous abortions, and gestational age beyond the first trimester at the time of evacuations. Recommendations. We recommend putting in place capacity to do routine histopathological examination of all products of conception especially those at high risk for a molar gestation either by clinical suspicion or by risk factors including advanced maternal age, advanced gestational age, and history of previous abortion because of high prevalence of complete mole

Table_1_Estimating the effects of COVID-19 on essential health services utilization in Uganda and Bangladesh using data from routine health information systems.DOCX

BackgroundSince March 2020, the coronavirus disease 2019 (COVID-19) pandemic has been a major shock to health systems across the world. We examined national usage patterns for selected basic, essential health services, before and during the COVID-19 pandemic in Uganda and Bangladesh, to determine whether COVID-19 affected reporting of service utilization and the use of health services in each country.MethodsWe used routine health information system data since January 2017 to analyze reporting and service utilization patterns for a variety of health services. Using time series models to replicate pre-COVID-19 trajectories over time we estimated what levels would have been observed if COVID-19 had not occurred during the pandemic months, starting in March 2020. The difference between the observed and predicted levels is the COVID-19 effect on health services.ResultsThe time trend models for Uganda and Bangladesh closely replicated the levels and trajectories of service utilization during the 38 months prior to the COVID-19 pandemic. Our results indicate that COVID-19 had severe effects across all services, particularly during the first months of the pandemic, but COVID-19 impacts on health services and subsequent recovery varied by service type. In general, recovery to expected levels was slow and incomplete across the most affected services.ConclusionOur analytical approach based on national information system data could be very useful as a form of surveillance for health services disruptions from any cause leading to rapid responses from health service managers and policymakers.</p