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2353.Distance and Time to Clinic Are Associated with Increased Risk of Detectable HIV-1 Viral Load at a Peripheral Health Center in Rural Western Uganda
(US: Oxford University Press., 2022) Hendren, Cate; Ndizeye, Ronnie; Mumbere, Nobert; Rubinstein, Rebecca J.; Baguma, Emma; Muhindo, Rabbison; Goel, Varun; Ntaro, Moses; Siedner, Mark; Mulogo, Edgar
Antiretroviral therapy (ART) improves the health of people living with HIV (PLHIV) and reduces HIV transmission. While availability and efficacy of ART have improved in sub-Saharan Africa (SSA), access remains a challenge. Travel burden, measured as travel time, distance, and cost, has been posited as a potential barrier to ART. For example, a previous study at a large, urban referral center in Uganda showed GPS-measured distance was associated with clinic absenteeism. However, others suggest that PLHIV are willing to travel farther for HIV care because of stigma or for higher quality care. Less is known about the effect of travel burden in rural settings where transportation infrastructure is sparse, and there are few transportation options. Therefore, the objective of this study funded by the IDSA GERM Program was to explore potential associations between distance- and time-to-clinic in a highland area of rural western Uganda with HIV outcomes including viral suppression.
72 Weeks Post-Partum Follow-Up of Dolutegravir Versus Efavirenz Initiated in Late Pregnancy (DolPHIN-2): An Open-Label, Randomised Controlled Study
(The Lancet HIV, 2022) Malaba, Thokozile R.; Nakatudde, Irene; Kintu, Kenneth; Reynolds, Helen; Mrubata, Megan; Seden, Kay; Twimukye, Adelline; Hodel, Eva Maria; Wang, Duolao; Byamugisha, Josaphat; Bokako, Sharon; Waitt, Catriona
Late initiation of antiretrovirals in pregnancy is associated with increased risk of perinatal transmission and higher infant mortality. We report the final 72-week postpartum results for efficacy and safety of dolutegravir-based compared with efavirenz-based regimens in mothers and infants. DolPHIN-2 was a randomised, open-label trial. Pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating antiretroviral therapy in third trimester were eligible for inclusion. Eligible women were randomly assigned (1:1) to receive either dolutegravir-based (50 mg dolutegravir, 300 mg tenofovir disoproxil fumarate, and either 200 mg emtricitabine in South Africa or 300 mg lamivudine in Uganda) or efavirenz-based (fixed dose combination 600 mg tenofovir disoproxil fumarate plus either emtricitabine in South Africa or lamivudine in Uganda) therapy. The primary efficacy outcome was the time to a viral load of less than 50 copies per mL measured at 6, 12, 24, 48, and 72 weeks postpartum with a Cox model adjusting for viral load and CD4 cell count. Safety endpoints were summarised by the number of women and infants with events. This trial is registered with ClinicalTrials.gov, NCT03249181. Between Jan 23 and Aug 15, 2018, 280 women were screened for inclusion, of whom 268 (96%) women were randomly assigned: 133 (50%) to the efavirenz group and 135 (50%) to the dolutegravir group. 250 (93%; 125 [50%] in the efavirenz group and 125 [50%] in the dolutegravir group) women were included in the intention-to-treat analysis of efficacy. Median time to viral load of less than 50 copies per mL was 4·1 weeks (IQR 4·0–5·1) in the dolutegravir group compared with 12·1 weeks (10·7–13·3) in the efavirenz group (adjusted hazard ratio [HR] 1·93 [95% CI 1·5–2·5]). At 72 weeks postpartum, 116 (93%) mothers in the dolutegravir group and 114 (91%) in the efavirenz group had a viral load of less than 50 copies per mL. Of 57 (21%) mothers with a severe adverse event, three (2%) in the dolutegravir group and five (4%) in the efavirenz group were related to the drug (dolutegravir drug-related events were one woman each with suicidal ideation, suicide attempt, herpes zoster meningitis; efavirenz drug-related events were one woman each with suicide attempt and liver cirrhosis, and three people with drug-induced liver injury). Of 136 (56%) infants in whom severe adverse events were recorded, none were related to the study drugs. In addition to the three infant HIV infections detected at birth in the dolutegravir group that have been previously reported, an additional transmission in the efavirenz group occurred during breastfeeding despite optimal maternal viral suppression and serial negative infant tests in the first year of life. Dolutegravir was safe and well tolerated, supporting updated WHO treatment recommendations in pregnant and breastfeeding women. Infant HIV transmissions can occur during breastfeeding despite persistently undetectable maternal viral load highlighting the need for continued infant testing.
A 'hidden problem': Nature, prevalence and factors associated with sexual dysfunction in persons living with HIV/AIDS in Uganda
(Public Library of Science, 2024-03-07) Mutamba, Brian Byamah; Rukundo, Godfrey Zari; Sembajjwe, Wilber; Nakasujja, Noeline; Birabwa-Oketcho, Harriet; Mpango, Richard Stephen; Kinyanda, Eugene
We conducted a clinic-based cross-sectional survey among 710 people living with HIV/AIDS in stable 'sexual' relationships in central and southwestern Uganda. Although sexual function is rarely discussed due to the private nature of sexual life. Yet, sexual problems may predispose to negative health and social outcomes including marital conflict. Among individuals living with HIV/AIDS, sexual function and dysfunction have hardly been studied especially in sub-Saharan Africa. In this study, we aimed to determine the nature, prevalence and factors associated with sexual dysfunction (SD) among people living with HIV/AIDS (PLWHA) in Uganda. We conducted a clinic based cross sectional survey among 710 PLWHA in stable 'sexual' relationships in central region and southwestern Uganda. We collected data on socio-demographic characteristics (age, highest educational attainment, religion, food security, employment, income level, marital status and socio-economic status); psychiatric problems (major depressive disorder, suicidality and HIV-related neurocognitive impairment); psychosocial factors (maladaptive coping styles, negative life events, social support, resilience, HIV stigma); and clinical factors (CD4 counts, body weight, height, HIV clinical stage, treatment adherence). Sexual dysfunction (SD) was more prevalent in women (38.7%) than men (17.6%) and majority (89.3% of men and 66.3% of women) did not seek help for the SD. Among men, being of a religion other than Christianity was significantly associated with SD (OR = 5.30, 95%CI 1.60-17.51, p = 0.006). Among women, older age (> 45 years) (OR = 2.96, 95%CI 1.82-4.79, p<0.01), being widowed (OR = 1.80, 95%CI 1.03-3.12, p = 0.051) or being separated from the spouse (OR = 1.69, 95% CI 1.09-2.59, p = 0.051) were significantly associated with SD. Sexual dysfunction has considerable prevalence among PLWHA in Uganda. It is associated with socio-demographic, psychiatric and clinical illness factors. To further improve the quality of life of PLWHA, they should be screened for sexual dysfunction as part of routine assessment.
A 10 years Trend of Peptic Ulcer Disease and other Gastrointestinal Disorders in Northern Uganda
(East and Central African Journal of Surgery, 2016) Okello, T.R.; Ogwang, D.M; Pecorella, I.
The changing trend of GI disorders has not been expounded in our setting, there is need to examine the extent to which major endoscopically diagnosed upper GI disorders have changed in the last 10 years (2005 to 2015). Methods: This was a retrospective study in which endoscopically diagnosed GI disorders of Jan-Jun 2005 were compared with 2015 (10 years) for the same period Results: In the 10 years (2005 to 2015), the prevalence of peptic ulcer disease (PUD) reduced from 9.6% to 2.9% (P value 0.000), followed by esophageal varices from 10.3% to 4.0%, and duodenitis from 3.2% to 0.7% respectively. Gastritis increased from 18.4% to 48.2% (P value 0.000), followed by cancer esophagus from 3.2% to 5.1%. Conclusion: As the prevalence of PUD decreases in our community, gastritis increases hence patients with upper GI symptoms tend to suffer gastritis thus clinicians should focus on treating gastritis and eradication of Helicobacter pylori.
A 10-year retrospective study of lung cancer in Uganda
(BioMed Central Ltd, 2022-02) Bogere, Naghib; Bongomin, Felix; Katende, Andrew; Omaido, Blair Andrew; Namukwaya, Elizabeth; Mayanja-Kizza, Harriet; Walusansa, Victoria
Abstract Background Lung cancer is a leading cause of cancer-related deaths in Uganda. In this study, we aimed to describe the baseline characteristics and survival of patients with lung cancer at the Uganda Cancer Institute (UCI). Methods We retrospectively reviewed medical records of all patients with a histological diagnosis of lung cancer registered at UCI between January 2008 and August 2018. Data on demographic, clinical, and treatment characteristics, and vital status were abstracted and analyzed. Patients with undocumented vital status on the medical records were contacted through phone calls. We determined survival as time from histological diagnosis to death. The Kaplan-Meier survival analysis was performed to estimate the median survival time and the 5-year overall survival rate. Results Of the 207 patients enrolled, 56.5% (n = 117) were female, median age was 60 years (range: 20–94), 78.7% (n = 163) were never-smokers and 18 (8.7%) were living with HIV. Presumptive anti-tuberculosis treatment was given to 23.2% (n = 48). Majority had non-small cell lung cancer (96.6%, n = 200) with 74.5% (n = 149) adenocarcinoma and 19% (n = 38) squamous cell carcinoma. All had advanced (stage III or IV) disease with 96.1% (n = 199) in stage IV. Chemotherapy (44.9%, n = 93) and biological therapy (34.8%, n = 72) were the commonest treatments used. Overall survival at 6 months, 1-, 2- and 5-years was 41.7, 29.7, 11.8, and 1.7%, respectively. The median survival time of 4.4 months was not statistically significantly different between participants with NSCLC or SCLC (4.5 versus 3.9 months, p = .335). Conclusion In Uganda, adenocarcinoma is the predominant histologic subtype of lung cancer and patients are predominantly females, and non-smokers. Patients present late with advanced disease and poor overall survival. Public awareness should be heightened to facilitate early detection and improve outcomes.
A 10-Year Risk of Cardiovascular Disease among Patients with Severe Mental Illness at Mbarara Regional Referral Hospital, Southwestern Uganda
(BioMed Research International, 2020) Agaba, David Collins; Migisha, Richard; Lugobe, Henry Mark; Katamba, Godfrey; Ashaba, Scholastic
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide. Patients with severe mental illness (SMI) are at a higher risk for developing CVD and have a higher risk for harboring factors related to CVD. In addition to the effects of antipsychotic medications, unhealthy lifestyle factors, such as poor diet, inadequate physical activity, cigarette smoking, and sedentary behaviors, are known to be risk factors that may contribute to poor cardiovascular health in patients with SMI. Early identification of individuals at elevated risk of CVD is essential so that dietary and lifestyle modifications or pharmacological interventions can be prescribed to alleviate the risk of cardiovascular disease. The objective of the study was to determine the 10-year risk of cardiovascular disease among patients with severe mental illness at Mbarara Regional Referral Hospital, southwestern Uganda. We conducted a cross-sectional study at the outpatient mental health clinic of Mbarara Regional Referral Hospital, between October 2018 and March 2019. We used the Globorisk CVD risk score to estimate the 10-year risk of CVD among patients with SMI, using the online Globorisk calculator. Participants were then assigned to one of three categories depending on their 10-year CVD risk score: <3% (low), 3–10% (intermediate), and >10% (high). We calculated the risk scores of 125 participants aged 40-74 years. Most of the participants were female 75 (60%), had a diagnosis of bipolar disorder 75 (60%), and had mental illness for ≥10 years 57 (46%). Eighty five percent (85%) of the participants had intermediate to high 10-year risk of CVD (64% with intermediate and 21% with high risk). The average risk score was significantly higher in males compared to females, 8.82% versus 6.43%, p = 0:016. We detected a high 10-year risk of CVD in a significant proportion of patients with SMI in southwestern Uganda. We recommend lifestyle modifications and pharmacological interventions to reverse risk or delay progression to CVD in this patient population.
A bibliometric Analysis of Cancer Research in South Africa: study protocol
(BMJ open, 2015) Moodley, Jennifer; Singh, Vedantha; Kagina, Benjamin M.; Abdullahi, Leila; Hussey, Gregory D.
Cancer is an important and growing public health burden in South Africa (SA). Over the past few decades, there has been considerable scientific activity in cancer in SA. However, there has been limited analysis of cancer scientific publications. In this paper, we present a protocol for bibliometric analysis of cancer research conducted in SA. A comprehensive search of the journal databases PubMed, SCOPUS, Web of Science and EBSCO will be conducted to identify and retrieve data from primary peer-reviewed cancer research articles using a set of consensus search words. Articles that involve cancer research conducted in SA or using biological or clinical data from South African participants and published between 2004 and 2014 will be included in the study. Two independent researchers will screen the articles for eligibility. Bibliometric indicators and study characteristics will be extracted, entered into a database and analysed. The cancer disease site will be recorded and research will be classified using the Common Scientific Outline system. Data obtained will be analysed to determine SA's publication productivity index in cancer research. Annual trends in bibliometric indicators and the type of cancer research will be determined. The degree of collaboration in research conducted in SA will be analysed using co-authorship matrix software. A publication to disease type ratio will be used to assess scientific production relative to disease burden.
A cascade model of mentorship for frontline health workers in rural health facilities in Eastern Uganda: processes, achievements and lessons
(Global Health Action, 2017) Ajeani, Judith; Mangwi Ayiasi, Richard; Tetui, Moses; Ekirapa-Kiracho, Elizabeth; Namazzi, Gertrude; Muhumuza Kananura, Rornald; Namusoke Kiwanuka, Suzanne; Beyeza-Kashesya, Jolly
There is increasing demand for trainers to shift from traditional didactic training to innovative approaches that are more results-oriented. Mentorship is one such approach that could bridge the clinical knowledge gap among health workers. Objectives: This paper describes the experiences of an attempt to improve health-worker performance in maternal and newborn health in three rural districts through a mentoring process using the cascade model. The paper further highlights achievements and lessons learnt during implementation of the cascade model. Methods: The cascade model started with initial training of health workers from three districts of Pallisa, Kibuku and Kamuli from where potential local mentors were selected for further training and mentorship by central mentors. These local mentors then went on to conduct mentorship visits supported by the external mentors. The mentorship process concentrated on partograph use, newborn resuscitation, prevention and management of Post-Partum Haemorrhage (PPH), including active management of third stage of labour, preeclampsia management and management of the sick newborn. Data for this paper was obtained from key informant interviews with district-level managers and local mentors. Results: Mentorship improved several aspects of health-care delivery, ranging from improved competencies and responsiveness to emergencies and health-worker professionalism. In addition, due to better district leadership for Maternal and Newborn Health (MNH), there were improved supplies/medicine availability, team work and innovative local problem-solving approaches. Health workers were ultimately empowered to perform better. Conclusions: The study demonstrated that it is possible to improve the competencies of frontline health workers through performance enhancement for MNH services using locally built capacity in clinical mentorship for Emergency Obstetric and Newborn Care (EmONC). The cascade mentoring process needed strong external mentorship support at the start to ensure improved capacity among local mentors to provide mentorship among local district staff.
A case control study of the factors associated with occurrence of aerodigestive foreign bodies in children in a regional referral hospital in South Western Uganda
(BMC Ear Nose Throat Disord, 2016) Nakku, Doreen; Byaruhanga, Richard; Bajunirwe, Francis; Kyamwanga, Imelda T.
Aerodigestive foreign bodies (ADFB) in children are a common emergency in ENT clinics globally. The aim of this study was to determine the prevalence and common types of ADFB’s presenting to a referral hospital in South Western Uganda, and to review clinical presentation and factors that influence their occurrence among children under 12 years of age.
A case for urban liveability from below: exploring the politics of water and land access for greater liveability in Kampala, Uganda
(Research Sqaure, 2019) Nastar, Maryam; Isoke, Jennifer; Kulabako, Robinah; Silvestri, Giorgia
Improving urban liveability and prosperity is commonly set as a priority in urban development plans and policy around the world. Several annual reports produced by international consulting firms, media, and global agencies rank the liveability of cities based on a set of indicators, to represent the quality of life in these cities. The higher is the ranking, the more liveable is the city. In this paper, we argue that such quantitative approaches to framing and addressing urban liveability challenges leave little room to reflect on people's experiences of this liveability, which cannot be expressed through numbers. To illustrate our argument, we draw on empirical evidence of urban liveability challenges in access to water and land in Kampala, the capital city of Uganda, ranked recently as the most liveable East African city by various global agencies and media outlets. By showing that increasing the number of water connections does not guarantee improved access to water and sanitation in the long run, first, we demonstrate how urban liveability challenges are tightly linked with land-title issues in the city. Second, we highlight the political game-playing between the central government, the opposition, the traditional leadership, and the slum dwellers in governance processes of service delivery. Finally, by arguing that urban liveability can be enhanced by broadening political participation in city development planning, we discuss some of the strategies that can be used by communities to make collective claims towards improving their quality of life and the environment.th cities related poor air quality to specific health outcomes such as asthma or lung cancer.
A Case of Cryptococcal Lymphadenitis in an HIV-Infected Child
(AIDS research and human retroviruses, 2011) Natukunda, Eva; Musiime, Victor; Ssali, Francis; Kizito, Hilda; Kityo, Cissy; Mugyenyi, Peter
An 8-year-old HIV-positive antiretroviral therapy-naive child developed severe headache and generalized lymphadenopathy. The serum cryptococcal antigen (CRAG) test was positive, the histology on the lymph node biopsy revealed budding yeast cells, and Cryptococcus neoformans was isolated on culture of his cerebrospinal fluid. He was treated with intravenous amphotericin B followed by oral fluconazole with a good response. Therefore cryptococcal lymphadenitis should be considered in the differential diagnosis of children presenting with lymphadenopathy and a positive serum CRAG.
A case of forensic genomics in Uganda reveals animal ownership and low exotic genetic introgression in indigenous cattle
(Veterinary Medicine and Science, 2023-09-19) Masembe, Charles; Benda, Kirungi Katali; Opoola, Oluyinka; Ndinawe, Ruth Pamela; Beine, Peter; Mukiibi, Robert
The cattle industry contributes to Uganda's agricultural output. It faces challenges that include theft and parentage ascertainment. These challenges can benefit from recent molecular genomics and bioinformatics technologies. We employed genomic analyses to establish potential ownership of a group of nine cattle that were being claimed by two farmers in Uganda. We investigated the genetic relationship of Ugandan cattle with regional indigenous breeds as well as exotic breeds that are currently present in Uganda. In addition, we investigated regions that are likely to be under selection in the Ugandan cattle. Hair samples were collected from seven and two animals from farmers A and B, respectively. They were genotyped for 53,218 Single Nucleotide Polymorphism markers. To establish genetic relationships between the sampled animals, we performed genomic analyses including, principal component analysis (PCA), hierarchical clustering analysis and identity by state/descent. We also performed admixture and runs of homozygosity analyses to assess the ancestry composition and identify regions potentially under selection in Ugandan cattle, respectively. The seven animals from Farmer A were genetically close to each other but showed minimal relationship with the disputed animals. The two animals from Farmer B were genetically distant from each other but showed greater similarity to four of the disputed animals. Four of the disputed animals showed great dissimilarity from the animals of both farmers. Comparison of these with the reference breeds revealed minimal European exotic genetic introgression into these animals, but rather high similarity to the Sheko. Results also revealed high homozygosity in the major histocompatibility complex regions. Our results demonstrate the use of currently available genomic tools to empirically establish the ownership of cattle; these could be scaled up as a resourceful and viable tool that could be employed to support conflict resolution where reliable livestock identification is unavailable.
A Case of Palatal Perforation Caused by Toxoplasmosis
(Southern African Journal of HIV Medicine, 2010) Katusiime, Christine; Ocama, Ponsiano; Kambugu, Andrew
HIV infection has several oral manifestations, including oral candidiasis and oral hairy leucoplakia. Occasionally unusual presentations requiring rigorous investigations are seen, and in these cases the diagnosis sometimes remains a dilemma owing to limited investigation facilities.1-3 We present the case of a patient who presented with a puzzling oral lesion.
A case of toxoplasmic encephalitis in a patient on cancer chemotherapy in Uganda
(African Journals Online (AJOL), 2025-01-11) Mitala, Yekosani; Atwine, Raymond; Birungi, Abraham; Ambaru, Jacinta; Kuraishi, Baluku; Sekitene, Semei; Nuwagira, Edwin
Background: Reactivation of central nervous system (CNS) toxoplasmosis can be caused by immunosuppression (ISS) of any kind. However, anti-cancer chemotherapy combined with human immunodeficiency virus (HIV) induced ISS results in an atypical presentation that is fatal. Case presentation: A 46 years old man with a well-controlled infection of the human immunodeficiency virus presented with generalized tonic-clonic seizures following the second dose of anti-cancer chemotherapy for esophageal cancer. His brain's computerized tomography (CT) scan showed enlarged ventricles with no space-occupying lesions. Cerebrospinal fluid (CSF) smears stained with hematoxylin and eosin (H&E) revealed numerous bradyzoites and tachyzoites consistent with central nervous system toxoplasmosis. Conclusion: With a double burden of cancer and Human immunodeficiency virus (HIV) infection in low-income countries, this case raises awareness about the atypical presentation of CNS toxoplasmosis reactivation among patients on cancer chemotherapy.
A case-control study of Burkitt lymphoma in East Africa: are local health facilities an appropriate source of representative controls?
(Infectious Agents and Cancer, 2012) Baik, Sonya; Mbaziira, Mike; Williams, Makeda; Ogwang, Martin D.; Kinyera, Tobias; Emmanuel, Benjamin; Ziegler, John L.; Reynolds, Steven J.; Mbulaiteye, Sam M.
We investigated the feasibility and appropriateness of enrolling controls for Burkitt lymphoma (BL) from local health facilities in two regions in Uganda. Methods: BL case data were compiled from two local hospitals with capacity to diagnose and treat BL in Northwest and North-central regions of Uganda during 1997 to 2009. Local health facility data were compiled from children attending four representative local health facilities in the two regions over a two week period in May/June 2010. Age and sex patterns of BL cases and children at local facilities were compared and contrasted using frequency tables. Results: There were 999 BL cases diagnosed in the study area (92% of all BL cases treated at the hospitals): 64% were from North-central and 36% from North-west region. The mean age of BL cases was 7.0 years (standard deviation [SD] 3.0). Boys were younger than girls (6.6 years versus 7.2 years, P = 0.004) and cases from North-central region were younger than cases from North-west region (6.8 years versus 7.3 years, P = 0.014). There were 1012 children recorded at the four local health facilities: 91% at facilities in North-central region and 9% from facilities in North-west region. Daily attendance varied between 1 to 75 children per day. The mean age of children at health facilities was 2.2 years (SD 2.8); it did not differ by sex. Children at North-central region facilities were younger than children at North-west region facilities (1.8 years versus 6.6 years, P < 0.001). Conclusions: While many children attend local health facilities, confirming feasibility of obtaining controls, their mean age is much lower than BL cases. Health facilities may be suitable for obtaining young, but not older, controls.
A clinical score for identifying active tuberculosis while awaiting microbiological results: Development and validation of a multivariable prediction model in sub- Saharan Africa
(PLoS medicine, 2020) Baik, Yeonsoo; Rickman, Hannah M.; Hanrahan, Colleen F.; Mmolawa, Lesego; Kitonsa, Peter J.; Sewelana, Tsundzukana; Nalutaaya, Annet; Kendall, Emily A.; Lebina, Limakatso; Martinson, Neil; Katamba, Achilles; Dowdy, David W.
In highly resource-limited settings, many clinics lack same-day microbiological testing for active tuberculosis (TB). In these contexts, risk of pretreatment loss to follow-up is high, and a simple, easy-to-use clinical risk score could be useful. Methods and findings We analyzed data from adults tested for TB with Xpert MTB/RIF across 28 primary health clinics in rural South Africa (between July 2016 and January 2018). We used least absolute shrinkage and selection operator regression to identify characteristics associated with Xpert-confirmed TB and converted coefficients into a simple score. We assessed discrimination using receiver operating characteristic (ROC) curves, calibration using Cox linear logistic regression, and clinical utility using decision curves. We validated the score externally in a population of adults tested for TB across 4 primary health clinics in urban Uganda (between May 2018 and December 2019). Model development was repeated de novo with the Ugandan population to compare clinical scores. The South African and Ugandan cohorts included 701 and 106 individuals who tested positive for TB, respectively, and 686 and 281 randomly selected individuals who tested negative. Compared to the Ugandan cohort, the South African cohort was older (41% versus 19% aged 45 years or older), had similar breakdown of biological sex (48% versus 50% female), and had higher HIV prevalence (45% versus 34%). The final prediction model, scored from 0 to 10, included 6 characteristics: age, sex, HIV (2 points), diabetes, number of classical TB symptoms (cough, fever, weight loss,and night sweats; 1 point each), and >14-day symptom duration. Discrimination was moderate in the derivation (c-statistic = 0.82, 95% CI = 0.81 to 0.82) and validation (c-statistic = 0.75, 95% CI = 0.69 to 0.80) populations. A patient with 10% pretest probability of TB would have a posttest probability of 4% with a score of 3/10 versus 43% with a score of 7/10. The de novo Ugandan model contained similar characteristics and performed equally well. Our study may be subject to spectrum bias as we only included a random sample of people without TB from each cohort. This score is only meant to guide management while awaiting microbiological results, not intended as a community-based triage test (i.e., to identify individuals who should receive further testing). Conclusions In this study, we observed that a simple clinical risk score reasonably distinguished individuals with and without TB among those submitting sputum for diagnosis. Subject to prospective validation, this score might be useful in settings with constrained diagnostic resources where concern for pretreatment loss to follow-up is high.
A clinical score for identifying active tuberculosis while awaiting microbiological results: Development and validation of a multivariable prediction model in subSaharan Africa
(PLoS Med, 2020) Yeonsoo, Baik; Hannah, M. Rickman; Colleen, F. Hanrahan; Lesego, Mmolawa; Peter, J. Kitonsa; Tsundzukana, Sewelana; Nalutaaya, Annet; Emily, A. Kendall; Limakatso, Lebina; Neil, Martinson; Katamba, Achilles; David, W. Dowdy
Background In highly resource-limited settings, many clinics lack same-day microbiological testing for active tuberculosis (TB). In these contexts, risk of pretreatment loss to follow-up is high, and a simple, easy-to-use clinical risk score could be useful. Methods and findings We analyzed data from adults tested for TB with Xpert MTB/RIF across 28 primary health clinics in rural South Africa (between July 2016 and January 2018). We used least absolute shrinkage and selection operator regression to identify characteristics associated with Xpert-confirmed TB and converted coefficients into a simple score. We assessed discrimination using receiver operating characteristic (ROC) curves, calibration using Cox linear logistic regression, and clinical utility using decision curves. We validated the score externally in a population of adults tested for TB across 4 primary health clinics in urban Uganda (between May 2018 and December 2019). Model development was repeated de novo with the Ugandan population to compare clinical scores. The South African and Ugandan cohorts included 701 and 106 individuals who tested positive for TB, respectively, and 686 and 281 randomly selected individuals who tested negative. Compared to the Ugandan cohort, the South African cohort was older (41% versus 19% aged 45 years or older), had similar breakdown of biological sex (48% versus 50% female), and had higher HIV prevalence (45% versus 34%). The final prediction model, scored from 0 to 10, included 6 characteristics: age, sex, HIV (2 points), diabetes, number of classical TB symptoms (cough, fever, weight loss, and night sweats; 1 point each), and >14-day symptom duration. Discrimination was moderate in the derivation (c-statistic = 0.82, 95% CI = 0.81 to 0.82) and validation (c-statistic = 0.75, 95% CI = 0.69 to 0.80) populations. A patient with 10% pretest probability of TB would have a posttest probability of 4% with a score of 3/10 versus 43% with a score of 7/10. The de novo Ugandan model contained similar characteristics and performed equally well. Our study may be subject to spectrum bias as we only included a random sample of people without TB from each cohort. This score is only meant to guide management while awaiting microbiological results, not intended as a community-based triage test (i.e., to identify individuals who should receive further testing). Conclusions In this study, we observed that a simple clinical risk score reasonably distinguished individuals with and without TB among those submitting sputum for diagnosis. Subject to prospective validation, this score might be useful in settings with constrained diagnostic resources where concern for pretreatment loss to follow-up is high.
A cluster randomised trial to evaluate the effectiveness of household alcohol‑based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol
(Trials, 2023-04-17) Chebet, Martin; Mukunya, David; Faragher, Eric Brian; Wandabwa, Julius; Weeks, Andrew
Infections are one of the leading causes of death in the neonatal period. This trial aims to evaluate if the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use prevents severe infections (including sepsis, diarrhoea, pneumonia, or death) among infants during the first three postnatal months.
A Cluster Randomized Trial of Routine HIV-1 Viral Load Monitoring in Zambia: Study Design, Implementation, and Baseline Cohort Characteristics
(PLoS One, 2010) Koethe, John R.; Westfall, Andrew O.; Luhanga, Dora K.; Clark, Gina M.; Goldman, Jason D.; Mulenga, Priscilla L.; Cantrell, Ronald A.; Chi, Benjamin H.; Zulu, Isaac; Saag, Michael S.; Stringer, Jeffrey S. A.
The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree).Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months.From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites.A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings.
A Cluster-Randomised Trial to Compare Home-Based with Health Facility- Based Antiretroviral Treatment in Uganda: Study Design and Baseline Findings
(Bentham Science Publishers Ltd., 2007) Amuron, Barbara; Coutinho, Alex; Grosskurth, Heiner; Nabiryo, Christine; Birungi, Josephine; Namara, Geoffrey; Levin, Jonathan; Smith, Peter G.; Jaffar, Shabbar
The scale-up of antiretroviral therapy is progressing rapidly in Africa but with a limited evidence-base. We re- port the baseline results from a large pragmatic cluster-randomised trial comparing different strategies of ART delivery. The trial is integrated in normal health service delivery. 1453 subjects were recruited into the study. Significantly more women (71%) than men (29%) were recruited. The WHO HIV clinical stage at presentation did not differ significantly between men and women: 58% and 53% respectively were at WHO stage III or IV (p=0.9). Median CD4 counts (IQR) x 10 6 cells/l were 98 (28, 160) among men and 111 (36, 166) among women. Sixty-four percent of women and 61% men had plasma viral load 100,000 copies. Baseline characteris- tics did not change over time. Considerably fewer men than women presented for treatment.

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