Browsing by Author "Mugerwa, Henry"

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    Efficacy and Safety of Dolutegravir or Darunavir in Combination with Lamivudine plus either Zidovudine or Tenofovir for second-line Treatment of HIV Infection (NADIA): week 96 results from a Prospective, Multicentre, Open-label, Factorial, Randomised, Non-inferiority trial
    (The Lancet HIV, 2022) Paton, Nicholas I.; Musaazi, Joseph; Kityo, Cissy; Walimbwa, Stephen; Hoppe, Anne; Balyegisawa, Apolo; Mirembe, Grace; Lugemwa, Abbas; Ategeka, Gilbert; Mugerwa, Henry; Kambugu, Andrew
    WHO guidelines recommend dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) for second-line HIV therapy, with NRTI switching from first-line tenofovir to zidovudine. We aimed to examine whether dolutegravir is non-inferior to darunavir, the best-in-class protease inhibitor drug, and whether maintaining tenofovir in second-line therapy is non-inferior to switching to zidovudine. In this prospective, multicentre, open-label, factorial, randomised, non-inferiority trial (NADIA), participants with confirmed HIV first-line treatment failure (HIV-1 RNA ≥1000 copies per mL) were recruited at seven clinical sites in Kenya, Uganda, and Zimbabwe. Following a 2 × 2 factorial design and stratified by site and screening HIV-1 RNA concentration, participants were randomly assigned (1:1:1:1) to receive a 96-week regimen containing either dolutegravir (50 mg once daily) or ritonavir-boosted darunavir (800 mg of darunavir plus 100 mg of ritonavir once daily) in combination with either tenofovir (300 mg once daily) plus lamivudine (300 mg once daily) or zidovudine (300 mg twice daily) plus lamivudine (150 mg twice daily). The NRTI drugs allocated by randomisation were administered orally in fixed-dose combination pills; other drugs were administered orally as separate pills. The previously reported primary outcome was the proportion of participants with a plasma HIV-1 RNA concentration of less than 400 copies per mL at 48 weeks. Here, we report the main secondary outcome: the proportion of participants with a plasma HIV-1 RNA concentration of less than 400 copies per mL at 96 weeks (non-inferiority margin 12%). We analysed this outcome and safety outcomes in the intention-to-treat population, which excluded only those who were randomly assigned in error and withdrawn before receiving trial drugs. This study was registered at ClinicalTrials.gov, NCT03988452, and is complete.
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    Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda
    (Research Ethics, 2021) Nalubega, Sylivia; Cox, Karen; Mugerwa, Henry; Evans, Catrin
    There is a gap in evidence regarding how research trial closure processes are managed to ensure continuity of HIV care for HIV positive participants following trial closure within low income settings. This research aimed to establish how research staff in Uganda understood and practised post-trial care for HIV positive trial participants. A grounded theory study was conducted using in-depth individual interviews and focus group discussions with 22 research staff from three different trials in Uganda. The results indicated that researchers engaged in three main activities to support trial participants, including: (i) preparing for post-trial care, which included instituting trial closure guidelines, planning necessary resources, and informing trial participants about post-trial care; (ii) facilitating participants during trial exit by engaging in psychological and practical support activities and (iii) providing follow up care and support for participants after trial exit, to respond to the needs of trial participants which often arose after trial exit. This study established a need for a holistic approach to post-trial-care of HIV positive trial participants in Uganda, and the need to engage multiple stakeholders including ethics authorities.
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    Factors associated with virological nonsuppression among HIV-positive children receiving antiretroviral therapy at the Joint Clinical Research Centre in Lubowa, Kampala Uganda
    (PLoS One, 2021) Nabukeera, Sarah; Kagaayi, Joseph; Makumbi, Fredrick E.; Mugerwa, Henry; Matovu, Joseph K. B.
    While the proportion of HIV-positive children (under 15 years) enrolled on antiretroviral therapy (ART) has increased in recent years, up to 60% of children started on ART do not achieve virological suppression. We set out to determine the factors associated with virological non-suppression among children living with HIV receiving ART at a peri-urban HIV care clinic in Kampala, Uganda. Method This was a retrospective cohort study conducted at the pediatric HIV/AIDS clinic at the Joint Clinical Research Centre (JCRC) in Kampala, Uganda. Three hundred (300) HIV-positive children (0–14 years) were randomly selected from existing medical records and data on children’s socio-demographic and clinical characteristics (age at ART initiation, WHO clinical staging, and ART-induced side effects) were abstracted using a data abstraction form. Virological non-suppression was defined as a viral load ≥1000 copies/Ml of blood after six months of ART initiation. Incident rate ratios (IRRs) were determined as a measure of association between virological non-suppression and child/patient characteristics. The IRRs were obtained via a modified Poisson regression with corresponding 95% confidence intervals (95%CI). All analyses were done using statistical package, Stata version 15. Results The overall non-suppression rate among HIV-positive children on ART was 23%. Being at WHO clinical stage 4 at ART initiation [adj. IRR 2.74; 95%CI: 1.63, 4.61] and ART-induced side effects [adj. IRR 1.77; 95%CI: 1.06, 2.97] were significantly associated with non-suppression. Older age at ART initiation (age 5–9 years: [adj. IRR 0.42; 95%CI: 0.28, 0.65]; age 10–14 years: [adj. IRR 0.34; 95%CI: 0.18, 0.64] was less likely to be associated with virological non-suppression. Conclusion Nearly a quarter of HIV-positive children on ART had a non-suppressed viral load after six months of treatment. Being at WHO clinical stage 4 at ART initiation and ART-induced side effects were significantly associated with virological non-suppression while older age at ART initiation was protective. Our findings suggest a need for age-specific interventions, particularly those targeting children below five years of age, to improve virological suppression among HIV-positive children receiving ART in this setting.
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    High Prevalence of tuberculosis infection among medical students in Makerere University, Kampala: results of a cross sectional study
    (Archives of Public Health, 2013) Mugerwa, Henry; Byarugaba, Denis K.; Mpooya, Simon; Miremba, Penelope; Kalyang, Joan N.; Karamagi, Charles; Katamba, Achilles
    Uganda’s Ministry of Health registered a 12% increase in new Tuberculosis (TB) cases between 2001 and 2005. Of these, 20% were from Kampala district and most from Mulago national referral hospital where the largest and the oldest medical school is found. Medical students are likely to have an increased exposure to TB infection due to their training in hospitals compared to other university students. The study compared the prevalence of TB infection and associated factors among undergraduate medical and veterinary students in Makerere University, Uganda. Methods: This was a cross-sectional study with 232 medical and 250 veterinary undergraduate students. Socio-demographic and past medical history data was collected using questionnaires. A tuberculin skin test was performed on the volar aspect of the left forearm. An induration ≥10 mm in diameter after 48-72 hrs was considered positive. Logistic regression was used to determine association of independent variables with TB infection. Results: The prevalence of TB infection was higher in medical students (44.8%, 95% C.I= 38.4-51.3%) compared to veterinary students (35.2%, 95% C.I = 29.3-41.1%). The significant predictors of TB infection were: being a medical student (aOR=1.56, 95% CI = 1.05-2.31), male sex (aOR=1.75, 95% CI = 1.17-2.63), history of contact with a confirmed TB case (aOR=1.57, 95% CI = 1.06-2.31) and residing at home (aOR=2.08, 95% CI = 1.20-3.61). Among the medical students, having gone to a day compared to boarding high school (aOR=2.31, 95% CI = 1.06-5.04), involvement in extracurricular clinical exposure (aOR=3.39 95% CI = 1.60-7.16), male sex, residence at home, and history of contact with a TB case predicted TB infection. Conclusion: Medical students have a higher prevalence of TB infection than veterinary students probably due to increased exposure during training. There is a need to emphasize TB infection control measures in hospitals and the general community.
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    Performance of Frontloading for Smear Microscopy in the Diagnosis of Pulmonary Tuberculosis: A Cross- Sectional Study at a Referral Hospital in Uganda
    (PLoS ONE, 2012) Miremba, Penelope; Kalyango, Joan N.; Worodria, William; Mugerwa, Henry; Nakakawa, Ethel; Asiimwe, Benon B.
    To compare the performance of frontloading and the standard WHO method for diagnosis of pulmonary TB at Mulago Hospital in order to validate the technique in this setting. Methods: This was a cross-sectional study in which 229 adult ($18 years) TB suspects were consecutively enrolled. Suspects submitted three sputum samples as follows: at initial presentation, one hour after the first sample, and the next morning. The first and next morning samples formed the standard WHO method, while the first and the one hour later samples formed the frontloading method. Sample processing was by the standard N-acetyl L-cystein (NALC)-NaOH method, and fluorescent microscopy was done for both methods, while cultures of the first sample on Lowenstein-Jensen slants acted as a gold standard. The sensitivity, specificity and predictive values for the WHO standard and frontloading methods were compared. Results: The sensitivity of both the frontloading and standard schemes was 91.1% while their specificities were 86.2% and 91.7% respectively. There was excellent agreement between the diagnostic capacity of the two methods (kappa statistic = 0.87, P,0.0001). The positive predictive value for the frontloading scheme was 87.2% and that for the standard approach was 91.9%, while the negative predictive values were 90.4% and 90.9%, respectively. Among the HIV positive patients, frontloading identified 59/79 (74.7%) culture positive samples while the standard approach identified 55/79 (69.6%). In the HIV sero-negative category, on the other hand, front-loading identified 48/110 (43.6%) culture positive samples compared to 45/110 (40.9%) by the standard approach. Conclusion: Frontloading based on smear examination of two same-day sputum samples has a similar performance to the current standard method and would not be associated with any significant missed diagnosis. It may therefore be advocated for use in our setting so as to reduce time to completion of diagnosis and patient loss to follow-up.
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    Prevalence of non-communicable diseases among HIV positive patients on antiretroviral therapy at joint clinical research centre, Lubowa, Uganda
    (PLoS ONE, 2019) Kansiime, Sheila; Mwesigire, Doris; Mugerwa, Henry
    Antiretroviral therapy (ART) has changed the course of HIV/AIDs by enabling patients to live longer, raising concern of the co- existence of HIV with other chronic illnesses, notably non-communicable diseases (NCDs). NCDs are on the rise in developing countries and evidence shows higher occurrence among people living with HIV (PLHIV). In Uganda, the burden of NCDs among PLHIV remains largely unquantified. Objective To determine the prevalence of hypertension, osteoporosis, diabetes mellitus, renal impairment, asthma, cardiomyopathy and multi-morbidity among HIV positive patients, receiving Anti-Retroviral Therapy at Joint Clinical Research Centre, Lubowa, Uganda. Methods This was a cross-sectional study conducted among 387 systematically sampled patients, receiving ART at the Joint Clinical Research Centre, Lubowa, between March and April 2017. The study used data extracted from routine care patient files to identify individuals with non-communicable diseases. Prevalence of the NCDs was estimated and reported with 95% confidence intervals. Prevalence was also reported at various levels of socio- demographic, behavioural and clinical factors. Results The overall prevalence of having at least one NCD was 20.7% (95% CI: 16.7–24.5). The prevalence of hypertension was 12.4% (95% CI: 9.1–15.7), osteoporosis 6.5% (95% CI: 4.0–8.9), diabetes mellitus 4.7% (95% CI: 2.6–6.8), renal impairment 1.6% (95% CI: 0.3–2.8), asthma 1.6% (95% CI: 0.3–2.8), and cardiomyopathy 1.3% (95% CI: 0.2–2.4). Prevalence of multi-morbidity was 4.7% (95% CI: 2.6–6.8). Prevalence was significantly higher among older participants, widowed participants and individuals with an opportunistic infection. Conclusion Non-communicable diseases are common among people living with HIV. There is need to encourage early diagnosis and treatment of non-communicable diseases in PLHIV in Uganda.