Dyslipidemia among adult people living with HIV on dolutegravir - based antiretroviral therapy at a private tertiary hospital in Kampala, Uganda: burden and determinants.

BACKGROUND: Understanding the burden of dyslipidemia and its associated factors among adult people living with HIV on dolutegravir (DTG) based anti-retroviral therapy (ART) is critical to provide clinical guidance and risk reduction strategies in our setting. METHODS: We conducted a cross-sectional study on adult people living with HIV on DTG based ART between July and August 2022 at Mengo Hospital, a private not for profit missionary hospital owned by the Church of Uganda. Dyslipidemia was defined as: Total cholesterol (TC) ≥ 5.2 mmol/l, or high-density lipoprotein (HDL) < 1 mmol/l for men and < 1.3 mmol/l for women, or triglycerides (TG) ≥ 1.7 mmol/l, and low-density lipoprotein (LDL) ≥ 3.4 mmol/l. A participant was considered to have dyslipidemia if they had any of the lipid profile parameters in the above ranges. Socio-demographic information, clinical data and behavioral characteristics were collected. Fasting lipid profile and fasting blood glucose levels were also measured. Bivariate and multivariate analyses were done using a generalized linear model regression of the Poisson family with a log link (modified Poisson) using robust standard errors since the prevalence of dyslipidemia was more than 10%. Adjusted prevalence ratios (PR) were reported with their 95% confidence intervals (CI). A p-value of less than 0.05 was considered statistically significant. RESULTS: A total of 341 participants were included. The prevalence of dyslipidemia was 78.0%, (95%CI:73.3-82.1). The highest prevalence was for low HDL (72.1%, 95%CI 67.1-76.7) followed by high TG (20.2%, 95%CI: 16.3-24.9), high TC (12.0%, 95%CI: 9.0-15.9) and high LDL (6.5%, 95%CI: 4.3-9.6). Female sex (aPR:1.55, 95%CI: 1.32-1.84, p < 0.001) and previous use of protease inhibitor (PI) based ART regimen (aPR:1.26, 95%CI: 1.04-1.53, p = 0.018) were significantly associated with dyslipidemia. CONCLUSION: We demonstrate that the prevalence of dyslipidemia is very high as it was present in more than three quarters of the study participants. Female sex and previous use of PI based ART regimen were significantly associated with dyslipidemia. Management of dyslipidemia should be integrated in the HIV treatment package and we recommend further inquiry into the temporal relationship between dyslipidemia and DTG among ART patients, if any.

Iron deficiency in whole blood donors in a resource-poor setting: A cross-sectional study in Uganda.

BACKGROUND AND OBJECTIVE: Blood donation is known to result in iron deficiency (ID), with a higher prevalence in females. There is little published data on the frequency of ID among blood donors in resource-poor settings. We determined the prevalence of ID in blood donors in Uganda. METHODS: We conducted a descriptive cross-sectional study at the Uganda Blood Transfusion Service, Kampala from December 2021 to February 2022. A sample of 500 whole blood donors was enrolled. The evaluation included demographic characteristics, donation history, nutritional history, complete blood count, and serum ferritin. The primary outcome was the proportion of donors with serum ferritin <15 µg/L. RESULTS: The median (IQR) serum ferritin was 25 (12-47) µg/L and 89 (52-133) µg/L among female and male donors respectively. The prevalence of iron deficiency (serum ferritin <15 µg/L) among donating individuals was 11.5% (8.7-14.9), while among low haemoglobin deferrals, 61.5% (50.9-71.1). The prevalence was high among females [33.0% (27.9-38.6)] compared with males [2.5% (1.0-5.8)], but even higher among females younger than 24 years [35.4% (29.2-42.1)]. Factors associated with ID (adjusted odds ratio, 95% Cl, and significance) were; female donors (15.81, 5.17, 48.28, p < 0.001) and a high RDW (6.89, 2.99, 15.90, p < 0.001). We found a moderate correlation between serum ferritin and RDW (r = -0.419 and -0.487 for males and females respectively). CONCLUSION: Iron deficiency is common among blood donors in Uganda, affecting mostly young female donors. Considerations to adopt evidence-based strategies to prevent and manage ID among blood donors-such as serum ferritin monitoring and iron supplementation are highly recommended.

Socio-economic and education related inequities in use of modern contraceptive in seven sub-regions in Uganda.

BACKGROUND: Advocacy for equity in health service utilization and access, including Family Planning (FP) continues to be a cornerstone in increasing universal health coverage. Inequities in Family planning are highlighted by the differences in reproductive health outcomes or in the distribution of resources among different population groups. In this study we examine inequities in use of modern contraceptives with respect to Socio-economic and Education dimensions in seven sub-regions in Uganda. METHODS: The data were obtained from a baseline cross-sectional study in seven statistical regions where a program entitled "Reducing High Fertility Rates and Improving Sexual Reproductive Health Outcomes in Uganda, (RISE)" is implemented in Uganda. There was a total of 3,607 respondents, half of whom were women of reproductive age (15-49 years) and the other half men (18-54 years). Equity in family planning utilization was assessed by geography, wealth/economic and social-demographics. The use of modern family planning was measured as; using or not using modern FP. Concentration indices were used to measure the degree of Inequality in the use of modern contraceptives. Prevalence Ratios to compare use of modern FP were computed using modified Poisson regression run in STATA V15. RESULTS: Three-quarters (75.6%) of the participants in rural areas were married compared to only 63% in the urban. Overall use of modern contraceptives was 34.2% [CI:30.9, 37.6], without significant variation by rural/urban settings. Women in the higher socio-economic status (SES) were more advantaged in use of modern contraceptives compared to lower SES women. The overall Erreygers Concentration Index, as a measure of inequity, was 0.172, p<0.001. Overall, inequity in use of modern contraceptives by education was highest in favor of women with higher education (ECI=0.146, p=0.0001), and the concentration of use of modern contraceptives in women with higher education was significant in the rural but not urban areas CONCLUSION: Inequities in the use of modern contraceptives still exist in favor of women with more education or higher socio-economic status, mainly in the rural settings. Focused programmatic interventions in rural settings should be delivered if universal Family Planning uptake is to be improved.

Evaluating women's acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians: a mixed methods study.

BACKGROUND: Studies evaluating task sharing in postabortion care have mainly focused on women in first trimester and many lack a qualitative component. We aimed to evaluate patient acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians and also gained a deeper understanding of the patients' lived treatment experiences in Uganda. METHODS: Our mixed methods study combined 1140 structured interview data from a randomized controlled equivalence trial and in-depth interviews (n = 28) among women managed with misoprostol for second trimester incomplete abortion at 14 public health facilities in Uganda. Acceptability, our main outcome, was measured at the 14-day follow-up visit using a structured questionnaire as a composite variable of: 1) treatment experience (as expected/ better than expected/ worse than expected), and 2) satisfaction - if patient would recommend the treatment to a friend or choose the method again. We used generalized mixed effects models to obtain the risk difference in acceptable post abortion care between midwife and physician groups. We used inductive content analysis for qualitative data. RESULTS: From 14th August 2018 to 16th November 2021, we assessed 7190 women for eligibility and randomized 1191 (593 to midwife and 598 to physician). We successfully followed up 1140 women and 1071 (94%) found the treatment acceptable. The adjusted risk difference was 1.2% (95% CI, - 1.2 to 3.6%) between the two groups, and within our predefined equivalence range of - 5 to + 5%. Treatment success and feeling calm and safe after treatment enhanced acceptability while experience of side effects and worrying bleeding patterns reduced satisfaction. CONCLUSIONS: Misoprostol treatment of uncomplicated second trimester incomplete abortion was equally and highly acceptable to women when care was provided by midwives compared with physicians. In settings that lack adequate staffing levels of physicians or where midwives are available to provide misoprostol, task sharing second trimester medical PAC with midwives increases patient's access to postabortion care services. TRIAL REGISTRATION: ClinicalTrials.gov NCT03622073.

Approximately 9.6% of abortion-related deaths occur in Sub-Saharan Africa. These deaths can be prevented if unintended pregnancies are avoided, women can access safe abortions within the expectations of the country's laws, and post abortion care (PAC) services are provided equitably. Previous research shows that women with abortion complications in the first trimester of pregnancy can be treated with misoprostol by either midwives or physicians. This sharing of tasks between the midwives and physicians is safe, effective, and acceptable. However, there is a gap in evidence on task sharing in the second trimester. To check practicability of task sharing in second trimester, we aimed to evaluate patient acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians and also gained a deeper understanding of the patients' lived treatment experiences. Our study therefore combined quantitative and qualitative approaches. Women's acceptability of misoprostol treatment for incomplete second trimester abortion was found to be equally acceptable when provided by midwives compared with physicians. Treatment success, feeling calm and safe after treatment increased acceptability, while experience of side effects and worrying bleeding patterns reduced satisfaction. Counselling of women may address some of these problems since it provides reassurance and reduces anxiety. In settings that lack adequate staffing levels of physicians or where midwives are available to provide misoprostol, task sharing second trimester medical PAC with midwives increases patient's access to PAC services.

Lifejacket wear and the associated factors among boaters involved in occupational boating activities on Lake Albert, Uganda: a cross-sectional survey.

BACKGROUND: Drowning death rates in lakeside fishing communities in Uganda are the highest recorded globally. Over 95% of people who drowned from a boating activity in Uganda were not wearing a lifejacket. This study describes the prevalence of lifejacket wear and associated factors among boaters involved in occupational boating activities on Lake Albert, Uganda. METHODS: We conducted a cross-sectional survey, grounded on etic epistemology and a positivist ontological paradigm. We interviewed 1343 boaters across 18 landing sites on Lake Albert, Uganda. Lifejacket wear was assessed through observation as boaters disembarked from their boats and self-reported wear for those who 'always wore a life jacket while on the lake'. We used a mixed-effects multilevel Poisson regression, with landing site-specific random intercepts to elicit associations with lifejacket wear. We report adjusted prevalence ratios (PRs) at 95% confidence intervals. RESULTS: The majority of respondents were male, 99.6% (1338/1343), and the largest proportion, 38.4% (516/1343) was aged 20-29 years. Observed lifejacket wear was 0.7% (10/1343). However, self-reported wear was 31.9% (428/1343). Tertiary-level education (adjusted PR 1.57, 95% CI 1.29- 1.91), boat occupancy of at least four people (adjusted PR 2.12, 95% CI 1.28 - 3.52), big boat size (adjusted PR 1.55, 95% CI 1.13 - 2.12) and attending a lifejacket-use training session (adjusted PR 1.25, 95% CI 1.01 - 1.56) were associated with higher prevalence of self-reported lifejacket wear. Self-reported wear was lower among the 30-39 year-olds compared to those who were aged less than 20 years (adjusted PR 0.66, 95% CI 0.45 - 0.99). CONCLUSION: Lifejacket wear was low. Training on lifejacket use may improve wear among boaters involved in occupational boating activities on Lake Albert.

Tobacco Smoking and Associated Factors Among People Living With HIV in Uganda.

INTRODUCTION: The prevalence of smoking among people living with HIV (PLWH) in Uganda is high. AIMS AND METHODS: We assessed the smoking patterns, behaviors, and associated factors among PLWH in Uganda through a cross-sectional survey. Descriptive statistics were used to describe smoking patterns and behaviors. Logistic regression was used to identify factors associated with current smoking status. RESULTS: We recruited 777 participants between October and November 2019: 387 (49.8%) current smokers and 390 (50.2%) nonsmokers. 60.9% were males, and the mean age was 40.5 (SD 10.7) years. In multivariate logistic regression, the following increased the odds of being a current smoker: being male (odds ratio [OR] 6.60 [95% confidence interval, CI = 4.34-10.04]), having at least two smokers among five closest friends (OR 3.97 [95% CI = 2.08-7.59]), living in smoking-permitted households (OR 5.83 [95% CI = 3.32-10.23]), alcohol use (OR 3.96 [95% CI = 2.34-6.71]), a higher perceived stress score (OR 2.23 [95% CI = 1.50-3.34]), and higher health-related quality of life (OR 5.25 [95% CI = 1.18-23.35]). Among smokers, the mean Fagerström Test for Nicotine Dependence score was 3.0 (SD 1.9), and 52.5% were making plans to quit. Self-efficacy to resist smoking and knowledge of the impact of smoking on PLWH's health were low. CONCLUSIONS: Being male, having at least two smokers among five closest friends, living in smoking-permitted households, alcohol use, higher perceived stress scores, and higher health-related quality of life were associated with being a current smoker. Smokers had low to moderate nicotine dependence, high willingness to quit, and low self-efficacy. IMPLICATIONS: Future behavioral smoking cessation interventions for PLWH should address co-consumption with alcohol and comorbid mental health conditions that are common among PLWH such as stress. In addition, they should take into account the lack of knowledge among this population of the impact of smoking on their health, and low self-efficacy. Given the relatively low levels of nicotine dependency and high levels of willingness to quit in our sample, smoking cessation interventions, if offered, are likely to support this population in achieving long-term smoking abstinence.

Piperaquine concentration and malaria treatment outcomes in Ugandan children treated for severe malaria with intravenous Artesunate or quinine plus Dihydroartemisinin-Piperaquine.

BACKGROUND: Treatment for severe malaria must be prompt with effective parenteral antimalarial drugs for at least 24 h to achieve fast parasite clearance, and when the patient can tolerate oral therapy, treatment should be completed with effective artemisinin based combination therapy (ACT) for complete parasite clearance and to prevent recrudescence. We evaluated piperaquine concentration and malaria treatment outcomes among Ugandan children treated for severe malaria with intravenous artesunate (AS) or quinine (QN) plus dihydroartemisinin-piperaquine (DP), in Tororo District Hospital in Eastern Uganda. METHODS: Capillary blood piperaquine concentration data were obtained from a randomized clinical trial whose objective was to evaluate parasite clearance, 42-day parasitological treatment outcomes and safety, following treatment of severe malaria with intravenous AS or QN, plus artemether-lumefantrine or DP among children in Tororo District Hospital, in Eastern Uganda. RESULTS: Piperaquine concentration data from 150 participants who received DP were analyzed. Participants with unadjusted treatment failure had lower median day 7 capillary piperaquine concentration than those with treatment success (34.7 (IQR) (17.9-49.1) vs 66.7 (IQR) (41.8-81.9), p < 0.001), and lower than the recommended day 7 cut off level of 57 ng/mL. There was no difference in median capillary piperaquine concentrations among participants with re-infection and recrudescence (35.3 (IQR) (17.9-55.2) vs 34.8 (IQR) (18.1-45.1), p = 0.847). The risk of treatment failure was two times higher among children with low (< 57 ng/mL) day 7 capillary piperaquine concentration (relative risk: 2.1 CI 1.4-3.1), p < 0.001) compared to children with high day 7 capillary piperaquine concentrations (> 57 ng/mL). CONCLUSION: Considering the low day 7 concentrations of piperaquine reported in the patients studied here, we suggest to adopt the recently recommended higher dose of DP in young children or a prolonged 5-day dosing in children living in malaria endemic areas who have suffered an initial episode of severe malaria in order to achieve adequate drug exposures for effective post-treatment prophylactic effects. TRIAL REGISTRATION: The study was registered with the Pan African Clinical Trial Registry (PACTR201110000321348). Registered 7th October 2011.

Schistosomiasis infection in pre-school aged children in Uganda: a qualitative descriptive study to identify routes of exposure.

BACKGROUND: Prevalence of schistosomiasis is high among children under five years in Uganda. Schistosomiasis control efforts over time have included periodic mass treatments in endemic areas for adults and school going children aged 5 years and above. This study explores behaviour practices of children age 2-4 years that increase the risk of schistosomiasis infection in this age group. METHODS: A qualitative descriptive study was conducted using in-depth interviews with 30 caregivers of children aged 2-4 years who tested positive for schistosomiasis in a national prevalence survey in 2017. Observations were done at water bodies where young children go with caretakers or other older children. The study was conducted in three Ugandan sub-regions of West Nile and East-central, and South-western with high, and low prevalence of schistosomiasis, respectively. Data were thematically analysed. Anonymised supporting photos from observations are also presented. RESULTS: Knowledge about schistosomiasis transmission was poor among caregivers, who concurrently had mixed right and wrong information. Reported avenues for contracting schistosomiasis included both correct: contact activities with infested water, and incorrect modes: contact with dirty water, sharing bathrooms, witchcraft, polluted air and contaminated food. The children in this study could have contracted schistosomiasis through the contact with infested water during activities such as bathing and playing, while their caregivers washed clothes, collected snail shells for poultry feeds, fetched water at the water bodies. These activities were reported by caregivers and observed in all study areas. Evidence of open defecation and urination in and near water bodies by adults and children was also observed. CONCLUSIONS: Pre-school children age 2-4 years are at a high risk of exposure to schistosomiasis while caretakers conduct activities in infested water bodies. There is need for prevention interventions to target children in their early stages of life to control schistosomiasis in this vulnerable population.

Health systems readiness to provide geriatric friendly care services in Uganda: a cross-sectional study.

BACKGROUND: As ageing emerges as the next public health threat in Africa, there is a paucity of information on how prepared its health systems are to provide geriatric friendly care services. In this study, we explored the readiness of Uganda's public health system to offer geriatric friendly care services in Southern Central Uganda. METHODS: Four districts with the highest proportion of old persons in Southern Central Uganda were purposively selected, and a cross-section of 18 randomly selected health facilities (HFs) were visited and assessed for availability of critical items deemed important for provision of geriatric friendly services; as derived from World Health Organization's Age-friendly primary health care centres toolkit. Data was collected using an adapted health facility geriatric assessment tool, entered into Epi-data software and analysed using STATA version 14. Kruskal-Wallis and Dunn's post hoc tests were conducted to determine any associations between readiness, health facility level, and district. RESULTS: The overall readiness index was 16.92 (SD ±4.19) (range 10.8-26.6). This differed across districts; Lwengo 17.91 (SD ±3.15), Rakai 17.63 (SD ±4.55), Bukomansimbi 16.51 (SD ±7.18), Kalungu 13.74 (SD ±2.56) and facility levels; Hospitals 26.62, Health centers four (HCIV) 20.05 and Health centers three (HCIII) 14.80. Low readiness was due to poor scores concerning; leadership (0%), financing (0%), human resources (1.7%) and health management information systems (HMIS) (11.8%) WHO building blocks. Higher-level HFs were statistically significantly friendlier than lower-level HFs (p = 0.015). The difference in readiness between HCIIIs and HCIVs was 2.39 (p = 0.025). CONCLUSION: There is a low readiness for public health facilities to provide geriatric friendly care services in Uganda. This is due to gaps in all of the health system building blocks. There is a need for health system reforms in Uganda to adequately cater for service provision for older adults if the 2020 global healthy ageing goal is to be met.

Risk factors for recurrent severe anemia among previously transfused children in Uganda: an age-matched case-control study.

BACKGROUND: In resource-poor settings, transfused children often experience recurrence of severe anemia (SA) following discharge from hospital. This study determined the factors associated with recurrent severe anemia (RSA) among previously transfused Ugandan children aged less than 5 years. METHODS: A case-control study was conducted in five hospitals in Uganda from March 2017 to September 2018. We prospectively enrolled 196 hospitalised children who had been transfused for severe anemia 2 weeks to 6 months prior to enrollment. Of these, 101 children (cases) were re-admitted with a hemoglobin [Hb] level of ≤6 g/dL and required transfusion; and 95 children (age-matched controls) were admitted for other clinical illness with a Hb > 6 g/dL. Children known to have sickle cell anemia, cancer, or bleeding disorders were excluded. Clinical and laboratory evaluation were done. Conditional logistic regression adjusted for age, was used to determine factors associated with RSA. RESULTS: The median time (IQR) between the earlier transfusion and enrollment was 3.5 (1.9-5.7) months for cases, and was 5.0 (2.9-6.0) months for controls (p-value = 0.015). Risk factors (adjusted odds ratio, 95% confidence interval, and significance) for development of RSA were: hemoglobinuria (36.33, 2.19-600.66, p = 0.012); sickle cell anemia - newly diagnosed (20.26, 2.33-176.37, p = 0.006); history of earlier previous transfusions (6.95, 1.36-35.61, p = 0.020) and malaria infection (6.47, 1.17-35.70, p = 0.032). CONCLUSION: Malaria chemoprevention, follow up visit for Hb check after discharge from hospital and sickle cell screening among previously transfused children represent practical strategies to prevent and identify children at risk for recurrent severe anemia. The cause of hemoglobinuria in children merits further investigations.

Prevalence and factors associated with dental caries in patients attending an HIV care clinic in Uganda: a cross sectional study.

BACKGROUND: Chronic Human Immunodeficiency Virus (HIV) infection is associated with reduced saliva flow rate due to infiltration of HIV and proliferation of CD8 lymphocytes in salivary glands. It is unclear whether HIV infection and antiretroviral therapy (ART) increase caries risk. This study aimed to determine the prevalence and factors associated with dental caries in HIV infected adults attending the Mulago Immune Suppression Syndrome (ISS) clinic in Uganda. METHODS: A cross-sectional study was conducted among HIV infected persons. Dental examinations were performed by two calibrated dentists using the WHO Radke's caries classification criteria and reported using the decayed (D), missing (M), filled (F), teeth (DMFT) index. The prevalence and factors associated with dental caries was examined through linear regression analyses. RESULTS: Overall, 748 participants (females = 491, 65.6%) with a mean age of 39 ± 9.4 years were included in the final analysis; of whom 83.7% had caries (DMFT> 0), with a significantly (p < 0.05) higher prevalence among females 86.6% than males 78.2%. The mean DMFT was 5.9 ± 5.5, with statistically significant differences based on gender (males 4.9 ± 4.8 and females 6.3 ± 5.9, p < 0.05) and duration on ART (< 2 years 4.8 ± 4.4, > 2 years but < 5 years 5.7 ± 5.5, > 5 years 6.6 ± 6.0 p < 0.05). The majority (67.2%) of participants reported brushing their teeth twice or more a day, and sugar intake was not associated with dental caries. CONCLUSION: Caries prevalence is high among HIV infected adults under care. Duration of ART was associated with increased risk and severity of caries. Therefore, we recommend integration of dental care in HIV treatment programs.

Measurement error of mean sac diameter and crown-rump length among pregnant women at Mulago hospital, Uganda.

BACKGROUND: Ultrasonography is essential in the prenatal diagnosis and care for the pregnant mothers. However, the measurements obtained often contain a small percentage of unavoidable error that may have serious clinical implications if substantial. We therefore evaluated the level of intra and inter-observer error in measuring mean sac diameter (MSD) and crown-rump length (CRL) in women between 6 and 10 weeks' gestation at Mulago hospital. METHODS: This was a cross-sectional study conducted from January to March 2016. We enrolled 56 women with an intrauterine single viable embryo. The women were scanned using a transvaginal (TVS) technique by two observers who were blinded of each other's measurements. Each observer measured the CRL twice and the MSD once for each woman. Intra-class correlation coefficients (ICCs), 95% limits of agreement (LOA) and technical error of measurement (TEM) were used for analysis. RESULTS: Intra-observer ICCs for CRL measurements were 0.995 and 0.993 while inter-observer ICCs were 0.988 for CRL and 0.955 for MSD measurements. Intra-observer 95% LOA for CRL were ± 2.04 mm and ± 1.66 mm. Inter-observer LOA were ± 2.35 mm for CRL and ± 4.87 mm for MSD. The intra-observer relative TEM for CRL were 4.62% and 3.70% whereas inter-observer relative TEM were 5.88% and 5.93% for CRL and MSD respectively. CONCLUSIONS: Intra- and inter-observer error of CRL and MSD measurements among pregnant women at Mulago hospital were acceptable. This implies that at Mulago hospital, the error in pregnancy dating is within acceptable margins of ±3 days in first trimester, and the CRL and MSD cut offs of ≥7 mm and ≥ 25 mm respectively are fit for diagnosis of miscarriage on TVS. These findings should be extrapolated to the whole country with caution. Sonographers can achieve acceptable and comparable diagnostic accuracy levels of MSD and CLR measurements with proper training and adherence to practice guidelines.

Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study.

INTRODUCTION: Adverse drug reactions (ADRs) are an important public health challenge worldwide; however, pharmacovigilance systems are plagued by under-reporting. Mobile technologies, including mobile applications such as Med Safety, could strengthen ADR reporting. We explored the acceptability, and factors that could influence uptake of, Med Safety for ADR reporting by health workers in Uganda. METHODS: The study took place between July and September 2020 in 12 HIV clinics in Uganda and employed a qualitative exploratory research design. We conducted 22 in-depth interviews and 3 mixed-gender focus group discussions (49 participants) with a diverse range of health workers. We analysed the data using a thematic approach. RESULTS: There was goodwill among the health workers to adopt Med Safety for ADR reporting and the majority would recommend the app to other health workers. Training with practice increased acceptability of the app. Uptake of the app was favoured by the younger, technology proficient, health worker demographic; the app's offline and two-way risk communication functionalities; availability of free internet hotspots at some health facilities; goodwill and willingness of health workers to report ADRs; and the cumbersome nature of conventional ADR reporting tools. Potential barriers to the uptake of Med Safety were the perceived lengthy processes of initial app registration and completion of multiple screens during ADR reporting; challenges with health workers' smartphones (incompatibility with application, no space for more applications, low battery charge); high cost of internet data; poor internet connectivity; difficulty in recognising ADRs, language barrier and poor feedback to ADR reporters. CONCLUSION: There was goodwill among the health workers to adopt Med Safety for ADR reporting and the majority would recommend the app to other health workers. Training with practice increased acceptability of the app and should be integral in all future app roll-out campaigns. The identified facilitators and barriers could be used to appropriately guide future research and implementation to promote the uptake of Med Safety for pharmacovigilance in low- and middle-income countries.

Prioritisation of Informed Health Choices (IHC) key concepts to be included in lower secondary school resources: A consensus study.

BACKGROUND: The Informed Health Choices Key Concepts are principles for thinking critically about healthcare claims and deciding what to do. The Key Concepts provide a framework for designing curricula, learning resources, and evaluation tools. OBJECTIVES: To prioritise which of the 49 Key Concepts to include in resources for lower secondary schools in East Africa. METHODS: Twelve judges used an iterative process to reach a consensus. The judges were curriculum specialists, teachers, and researchers from Kenya, Uganda, and Rwanda. After familiarising themselves with the concepts, they pilot-tested draft criteria for selecting and ordering the concepts. After agreeing on the criteria, nine judges independently assessed all 49 concepts and reached an initial consensus. We sought feedback on the draft consensus from other stakeholders, including teachers. After considering the feedback, nine judges independently reassessed the prioritised concepts and reached a consensus. The final set of concepts was determined after user-testing prototypes and pilot-testing the resources. RESULTS: The first panel of judges prioritised 29 concepts. Based on feedback from teachers, students, curriculum specialists, and members of the research team, two concepts were dropped. A second panel of nine judges prioritised 17 of the 27 concepts that emerged from the initial prioritisation and feedback. Based on feedback on prototypes of lessons and pilot-testing a set of 10 lessons, we determined that it was possible to introduce nine concepts in 10 single-period (40-minute) lessons. We included eight of the 17 prioritised concepts and one additional concept. CONCLUSION: Using an iterative process with explicit criteria, we prioritised nine concepts as a starting point for students to learn to think critically about healthcare claims and choices.

Effects of the Informed Health Choices secondary school intervention: A prospective meta-analysis.

AIM: The aim of this prospective meta-analysis was to synthesize the results of three cluster-randomized trials of an intervention designed to teach lower-secondary school students (age 14-16) to think critically about health choices. METHODS: We conducted the trials in Kenya, Rwanda, and Uganda. The intervention included a 2- to 3-day teacher training workshop, digital resources, and ten 40-min lessons. The lessons focused on nine key concepts. We did not intervene in control schools. The primary outcome was a passing score on a test (≥9 of 18 multiple-choice questions answered correctly). We performed random effects meta-analyses to estimate the overall adjusted odds ratios. Secondary outcomes included effects of the intervention on teachers. RESULTS: Altogether, 244 schools (11,344 students) took part in the three trials. The overall adjusted odds ratio was 5.5 (95% CI: 3.0-10.2; p < 0.0001) in favor of the intervention (high certainty evidence). This corresponds to 33% (95% CI: 25-40%) more students in the intervention schools passing the test. Overall, 3397 (58%) of 5846 students in intervention schools had a passing score. The overall adjusted odds ratio for teachers was 13.7(95% CI: 4.6-40.4; p < 0.0001), corresponding to 32% (95% CI: 6%-57%) more teachers in the intervention schools passing the test (moderate certainty evidence). Overall, 118 (97%) of 122 teachers in intervention schools had a passing score. CONCLUSIONS: The intervention led to a large improvement in the ability of students and teachers to think critically about health choices, but 42% of students in the intervention schools did not achieve a passing score.

Effects of the informed health choices secondary school intervention on the ability of students in Kenya to think critically about health choices: A cluster-randomized trial.

AIM: There is an overabundance of claims about the advantages and disadvantages of health interventions. People need to be able to appraise the reliability of these claims. The aim of this two-arm cluster-randomized trial was to evaluate the Informed Health Choices secondary school intervention designed to teach students to assess claims about the effects of health actions and make informed decisions. METHODS: We conducted the trial among students from 80 secondary schools in five subcounties in Kenya. We used stratified randomization to allocate schools to the intervention or control arm. The intervention included a 2-day teacher training workshop and 10 lessons that addressed nine prioritized key concepts for assessing claims about treatment effects. We did not intervene in the control schools. The primary outcome was the proportion of students with a passing score (≥ 9/18 correct answers) on the Critical Thinking about Health test, which included two multiple-choice questions for each concept. RESULTS: Between May 11, 2022, and July 8, 2022, we recruited 3362 students and 80 teachers. We allocated 1863 students and 40 teachers to the intervention and 1499 students and 40 teachers to the control arm. In the intervention schools, 1149/1863 (61.7%) of students achieved a passing score compared to 511/1499 (34.1%) in the control schools (odds ratio 3.6 (95% CI 2.5-5.2), p < 0.0001). CONCLUSIONS: The intervention had a large effect on students' ability to think critically about health interventions. It is possible to integrate the learning of critical thinking about health within Kenya secondary school curriculum.

Use of the informed health choices educational intervention to improve secondary students' ability to think critically about health interventions in Uganda: A cluster-randomized trial.

AIM: The aim was to evaluate the effect of the Informed Health Choices (IHC) educational intervention on secondary students' ability to assess health-related claims and make informed choices. METHODS: In a cluster-randomized trial, we randomized 80 secondary schools (students aged 13-17 years) in Uganda to the intervention or control (usual curriculum). The intervention included a 2-day teacher training workshop, 10 lessons accessed online by teachers and delivered in one school term. The lesson plans were developed for classrooms equipped with a blackboard or a blackboard and projector. The lessons addressed nine prioritized concepts. We used two multiple-choice questions for each concept to evaluate the students' ability to assess claims and make informed choices. The primary outcome was the proportion of students with a passing score (≥9 of 18 questions answered correctly). RESULTS: Eighty schools consented and were randomly allocated. A total of 2477 students in the 40 intervention schools and 2376 students in the 40 control schools participated in this trial. In the intervention schools, 1364 (55%) of students that completed the test had a passing score compared with 586 (25%) of students in the control schools (adjusted difference 33%, 95% CI 26%-39%). CONCLUSIONS: The IHC secondary school intervention improved students' ability to think critically and make informed choices. Well-designed digital resources may improve access to educational material, even in schools without computers or other information and communication technology (ICT). This could facilitate scaling-up use of the resources and help to address inequities associated with limited ICT access.

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.

INTRODUCTION: Combination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs for people living with HIV (PLHIV).Pharmacovigilance-monitoring the effects of medicines-is essential for understanding real-world drug safety. In Uganda, pharmacovigilance systems have only recently been developed, and rates of ADR reporting for cART are very low. Thus, the safety profile of medicines currently used to treat HIV and tuberculosis in our population is poorly understood.The Med Safety mobile application has been developed through the European Union's Innovative Medicines Initiative WEB-Recognising Adverse Drug Reactions project to promote digital pharmacovigilance. This mobile application has been approved for ADR-reporting by Uganda's National Drug Authority. However, the barriers and facilitators to Med Safety uptake, and its effectiveness in improving pharmacovigilance, are as yet unknown. METHODS AND ANALYSIS: A pragmatic cluster-randomised controlled trial will be implemented over 30 months at 191 intervention and 191 comparison cART sites to evaluate Med Safety. Using a randomisation sequence generated by the sealed envelope software, we shall randomly assign the 382 prescreened cART sites to the intervention and comparison arms. Each cART site is a cluster that consists of healthcare professionals and PLHIV receiving dolutegravir-based cART and/or isoniazid preventive therapy. Healthcare professionals enrolled in the intervention arm will be trained in the use of mobile-based, paper-based and web-based reporting, while those in the comparison arm will be trained in paper-based and web-based reporting only. ETHICS AND DISSEMINATION: Ethical approval was given by the School of Biomedical Sciences Research and Ethics Committee at Makerere University (SBS-REC-720), and administrative clearance was obtained from Uganda National Council for Science and Technology (HS1366ES). Study results will be shared with healthcare professionals, policymakers, the public and academia. TRIAL REGISTRATION NUMBER: PACTR202009822379650.

Learning to think critically about health using digital technology in Ugandan lower secondary schools: A contextual analysis.

INTRODUCTION: The world is awash with claims about the effects of health interventions. Many of these claims are untrustworthy because the bases are unreliable. Acting on unreliable claims can lead to waste of resources and poor health outcomes. Yet, most people lack the necessary skills to appraise the reliability of health claims. The Informed Health Choices (IHC) project aims to equip young people in Ugandan lower secondary schools with skills to think critically about health claims and to make good health choices by developing and evaluating digital learning resources. To ensure that we create resources that are suitable for use in Uganda's secondary schools and can be scaled up if found effective, we conducted a context analysis. We aimed to better understand opportunities and barriers related to demand for the resources, how the learning content overlaps with existing curriculum and conditions in secondary schools for accessing and using digital resources, in order to inform resource development. METHODS: We used a mixed methods approach and collected both qualitative and quantitative data. We conducted document analyses, key informant interviews, focus group discussions, school visits, and a telephone survey regarding information communication and technology (ICT). We used a nominal group technique to obtain consensus on the appropriate number and length of IHC lessons that should be planned in a school term. We developed and used a framework from the objectives to code the transcripts and generated summaries of query reports in Atlas.ti version 7. FINDINGS: Critical thinking is a key competency in the lower secondary school curriculum. However, the curriculum does not explicitly make provision to teach critical thinking about health, despite a need acknowledged by curriculum developers, teachers and students. Exam oriented teaching and a lack of learning resources are additional important barriers to teaching critical thinking about health. School closures and the subsequent introduction of online learning during the COVID-19 pandemic has accelerated teachers' use of digital equipment and learning resources for teaching. Although the government is committed to improving access to ICT in schools and teachers are open to using ICT, access to digital equipment, unreliable power and internet connections remain important hinderances to use of digital learning resources. CONCLUSIONS: There is a recognized need for learning resources to teach critical thinking about health in Ugandan lower secondary schools. Digital learning resources should be designed to be usable even in schools with limited access and equipment. Teacher training on use of ICT for teaching is needed.

Contextualizing critical thinking about health using digital technology in secondary schools in Kenya: a qualitative analysis.

BACKGROUND: Good health decisions depend on one's ability to think critically about health claims and make informed health choices. Young people can learn these skills through school-based interventions, but learning resources need to be low-cost and built around lessons that can fit into existing curricula. As a first step to developing and evaluating digital learning resources that are feasible to use in Kenyan secondary schools, we conducted a context analysis to explore interest in critical thinking for health, map where critical thinking about health best fits in the curriculum, explore conditions for introducing new learning resources, and describe the information and communication technology (ICT) infrastructure available for teaching and learning. METHODS: We employed a qualitative descriptive approach. We interviewed 15 key informants, carried out two focus group discussions, observed ICT conditions in five secondary schools, reviewed seven documents, and conducted an online catalog of ICT infrastructure in all schools (n=250) in Kisumu County. Participants included national curriculum developers, national ICT officers, teachers, and national examiners. We used a framework analysis approach to analyze data and report findings. FINDINGS: Although critical thinking is a core competence in the curriculum, critical thinking about health is not currently taught in Kenyan secondary schools. Teachers, health officials, and curriculum developers recognized the importance of teaching critical thinking about health in secondary schools. Stakeholders agreed that Informed Health Choices learning resources could be embedded in nine subjects. The National Institute of Curriculum Development regulates resources for learning; the development of new resources requires collaboration and approval from this body. Most schools do not use ICT for teaching, and for those few that do, the use is limited. Implementation of Kenya's ICT policy framework for schools faces several challenges which include inadequate ICT infrastructure, poor internet connectivity, and teachers' lack of training and experience. CONCLUSION: Teaching critical thinking about health is possible within the current Kenyan lower secondary school curriculum, but the learning resources will need to be designed for inclusion in and across existing subjects. The National ICT Plan and Vision for 2030 provides an opportunity for scale-up and integration of technology in teaching and learning environments, which can enable future use of digital resources in schools. However, given the current ICT condition in schools in the country, digital learning resources should be designed to function with limited ICT infrastructure, unstable Internet access, and for use by teachers with low levels of experience using digital technology.