Browsing by Author "Kambugu, Andrew"

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Assessment of Second-Line Antiretroviral Regimens for HIV Therapy in Africa
(Massachusetts Medical Society., 2014-07-17) Paton, I. Nicholas; Kityo, Cissy; Hoppe, Anne; Reid, Andrew; Kambugu, Andrew; Lugemwa, Abbas; Oosterhout, van J. Joep; Kiconco, Mary; Siika, Abraham; Mwebaze, Raymond; Abwola, Mary; Abongomera, George; Mweemba, Aggrey; Alima, Hillary; Atwongyeire, Dickens; Nyirenda, Rose; Boles, Justine; Thompson, Jennifer; Tumukunde, Dinah; Chidziva, Ennie; Mambule, Ivan; Arribas, R. Jose; Easterbrook, J. Philippa; Hakim, James; Walker, Sarah A.; Mugyenyi, Peter
Background The efficacy and toxic effects of nucleoside reverse-transcriptase inhibitors (NRTIs) are uncertain when these agents are used with a protease inhibitor in second-line therapy for human immunodeficiency virus (HIV) infection in resource-limited settings. Removing the NRTIs or replacing them with raltegravir may provide a benefit. Methods In this open-label trial in sub-Saharan Africa, we randomly assigned 1277 adults and adolescents with HIV infection and first-line treatment failure to receive a ritonavir-boosted protease inhibitor (lopinavir–ritonavir) plus clinician-selected NRTIs (NRTI group, 426 patients), a protease inhibitor plus raltegravir in a superiority comparison (raltegravir group, 433 patients), or protease-inhibitor monotherapy after 12 weeks of induction therapy with raltegravir in a noninferiority comparison (monotherapy group, 418 patients). The primary composite end point, good HIV disease control, was defined as survival with no new World Health Organization stage 4 events, a CD4+ count of more than 250 cells per cubic millimeter, and a viral load of less than 10,000 copies per milliliter or 10,000 copies or more with no protease resistance mutations at week 96 and was analyzed with the use of imputation of data (≤4%). Results Good HIV disease control was achieved in 60% of the patients (mean, 255 patients) in the NRTI group, 64% of the patients (mean, 277) in the raltegravir group (P=0.21 for the comparison with the NRTI group; superiority of raltegravir not shown), and 55% of the patients (mean, 232) in the monotherapy group (noninferiority of monotherapy not shown, based on a 10-percentage-point margin). There was no significant differ ence in rates of grade 3 or 4 adverse events among the three groups (P=0.82). The viral load was less than 400 copies per milliliter in 86% of patients in the NRTI group, 86% in the raltegravir group (P=0.97), and 61% in the monotherapy group (P<0.001). Conclusions When given with a protease inhibitor in second-line therapy, NRTIs retained substantial virologic activity without evidence of increased toxicity, and there was no advantage to replacing them with raltegravir. Virologic control was inferior with protease-inhibitor monotherapy. (Funded by European and Developing Countries Clinical Trials Partnership and others; EARNEST Current Controlled Trials number, ISRCTN 37737787, and ClinicalTrials.gov number, NCT00988039.)
Establishing the State of Practice about Data Standards in Monitoring Healthcare Interventions for HIV in Uganda’s EMR-based Health Information Systems
(Science and Technology Publications, 2021-01) Kiwanuka, Achilles; Bagyendera, Moses; Wamema, Joseph; Alunyu, Andrew; Amiyo, Mercy; Kambugu, Andrew; Nabukenya, Josephine
Electronic Health Information Systems (EHIS) in Uganda are characterised by inaccessibility to reliable, timely and integrated data for effectively monitoring and tracking continuity of care for people living with HIV, exacerbated by disparate, fragmented EHIS in varying health system levels that are not interoperable and lack common data standards. In order for data to be comparable, there has to be uniformity in terms of standards that are employed in a uniform manner in all data management processes. In this study, we established the state of current practice regarding data and interoperability standards in monitoring and evaluating healthcare interventions for HIV in Uganda’s EMR-based health information systems. The study findings indicate that there are scanty practices and/or implementation of the eHealth standards (data and interoperability), and limited to noncompliance of monitoring these standards in the implementation of the HIV healthcare interventions. Accordingly, our study recommendations point to the need of designing data and interoperability frameworks to provide for the specific set of standards, protocols, procedures, best practices and policies for eHealth standardisation in Uganda’s health system.
Feasibility and acceptability of integrating hepatitis B care into routine HIV services: a qualitative study among health care providers and patients in West Nile region, Uganda
(BMC Springer Nature, 2023-01-20) Mutyoba, Joan Nankya; Wandera, Claude; Ejalu, David; Seremba, Emmanuel; Beyagira, Rachel; Amandua, Jacinto; Mugagga, Kaggwa; Kambugu, Andrew; Muganzi, Alex; Easterbrook, Philippa; Ocama, Ponsiano
Despite facing a dual burden of HBV and HIV, Africa lacks experience in ofering integrated care for HIV and HBV. To contextualize individual and group-level feasibility and acceptability of an integrated HIV/HBV care model, we explored perspectives of health care providers and care recipients on feasibility and acceptability of integration. In two regional hospitals of West Nile region, we performed a demonstration project to assess feasibility and acceptability of merging the care of HBV-monoinfected patients with existing HIV care system. Using interviews with health care providers as key informants, and 6 focus groups discussions with 3 groups of patients, we explored feasibility [(i)whether integration is perceived to ft within the existing healthcare infrastructure, (ii) perceived ease of implementation of HIV/HBV integrated care, and (iii) perceived sustainability of integration] and acceptability [whether the HIV/HBV care model is perceived as (i) suitable, (ii) satisfying and attractive (iii) there is perceived demand, need and intention to recommend its use]. We audio-recorded the interviews and data was analysed using framework analysis. The following themes emerged from the data (i) integrating HBV into HIV care is perceived to be feasible, ft and benefcial, after making requisite adjustments (ii) integration is acceptable due to the need for both free treatment and anticipated collaboration between HIV and HBV clients in terms of peer-support (iii) there are concerns about the likely rise in stigma and the lack of community awareness about integrated care. The integrated HIV/HBV care model is feasible and acceptable among both providers and recipients. Necessary adjustments to the existing care system, including training, for community sensitization on the reasons and signifcance of integration are required.
Integrating hepatitis B care and treatment with existing HIV services is possible: cost of integrated HIV and hepatitis B treatment in a low-resource setting: a cross-sectional hospital-based cost-minimisation assessment
(BMJ Publishing Group Ltd, 2022-07-01) Ejalu, David Livingstone; Mutyoba, Joan N; Wandera, Claude; Seremba, Emmanuel; Kambugu, Andrew; Muganzi, Alex; Beyagira, Racheal; Amandua, Jacinto; Mugagga, Kaggwa; Easterbrook, Philippa; Ocama, Ponsiano
Hepatitis B and HIV care share health system challenges in the implementation of primary prevention, screening, early linkage to care, monitoring of therapeutic success and long-term medication adherence. Arua regional referral hospital (RRH) and Koboko district hospital (DH), the West Nile region of Uganda. A cross-sectional hospital-based cost minimisation study from the providers’ perspective considers financial costs to measure the amount of money spent on resources used in the stand-alone and integrated pathways. Clinic inputs and procurement invoices, budgetary documents, open market information and expert opinion. Data were extracted from 3121 files of HIV and hepatitis B virus (HBV) monoinfected patients from the two study sites. To estimate provider costs associated with running an integrated HBV and HIV clinical pathway for patients on lifelong treatment in low-resource setting in Uganda. Outcome measures The annual cost per patient was simulated based on the total amount of resources spent for all the expected number of patient visits to the facility for HBV or HIV care per year. Findings showed that Arua hospital had a higher cost per patient in both clinics than did Koboko Hospital. The cost per HBV patient was US$163.59 in Arua and US$145.76 in Koboko while the cost per HIV patient was US$176.52 in Arua and US$173.23 in Koboko. The integration resulted in a total saving of US$36.73 per patient per year in Arua RRH and US$17.5 in Koboko DH.nThe application of the integrated Pathway in HIV and HBV patient management could improve hospital cost efficiency compared with operating stand-alone clinics.
Integrating hepatitis B care and treatment with existing HIV services is possible: cost of integrated HIV and hepatitis B treatment in a low-resource setting: a cross-sectional hospital-based cost-minimisation assessment
(BMJ, 2022-07-01) Ejalu, David Livingstone; Mutyoba, Joan N; Wandera, Claude; Seremba, Emmanuel; Kambugu, Andrew; Muganzi, Alex; Beyagira, Racheal; Amandua, Jacinto; Mugagga, Kaggwa; Easterbrook, Philippa; Ocama, Ponsiano
Hepatitis B and HIV care share health system challenges in the implementation of primary prevention, screening, early linkage to care, monitoring of therapeutic success and long-term medication adherence. Setting was Arua regional referral hospital (RRH) and Koboko district hospital (DH), the West Nile region of Uganda. The research design used was a cross-sectional hospital-based cost minimisation study from the providers’ perspective considers financial costs to measure the amount of money spent on resources used in the stand-alone and integrated pathways. Data sources were clinic inputs and procurement invoices, budgetary documents, open market information and expert opinion. Data were extracted from 3121 files of HIV and hepatitis B virus (HBV) monoinfected patients from the two study sites. The objective was to estimate provider costs associated with running an integrated HBV and HIV clinical pathway for patients on lifelong treatment in low-resource setting in Uganda. The outcome measures were the annual cost per patient was simulated based on the total amount of resources spent for all the expected number of patient visits to the facility for HBV or HIV care per year. Findings showed that Arua hospital had a higher cost per patient in both clinics than did Koboko Hospital. The cost per HBV patient was US$163.59 in Arua and US$145.76 in Koboko while the cost per HIV patient was US$176.52 in Arua and US$173.23 in Koboko. The integration resulted in a total saving of US$36.73 per patient per year in Arua RRH and US$17.5 in Koboko DH. In conclusion, the application of the integrated Pathway in HIV and HBV patient management could improve hospital cost efficiency compared with operating stand-alone clinics.
Investigating the Impediments to Accessing Reliable, Timely and Integrated Electronic Patient Data in Healthcare Sites in Uganda
(Science and Technology Publications,, 2021-01) Alunyu, Andrew Egwar; Wamema, Joseph; Kiwanuka, Achilles; Bagyendera, Moses; Amiyo, Mercy; Kambugu, Andrew; Nabukenya, Josephine
The purpose of collecting patient data is to support their care and wellbeing. Patient-centred care is attained by securely availing all records about the patient whenever it's necessary to the right persons and at the right time. However, healthcare providers have often failed to share integrated patient data on time due to limitations in accessing reliable patient data required to inform care/treatment decisions. This study aimed to investigate impediments to accessing reliable, timely and integrated patient data through investigating the processes for collection, analysis, and presentation of data across various healthcare sites in Uganda. A cross-sectional study design was followed, and data was collected from purposively selected National level (policymakers) and Sub-national level (health facilities). The field findings indicate various impediments to accessing patient data including but not limited to inadequate mechanisms for electronic health data collection, storage and access, non-standardised health data sharing mechanisms, inadequate Health Information System (HIS) and Information and Communication Technology (ICT) infrastructure, and inadequate skills, knowledge and training. Other impediments included; insufficient security and privacy measures, weak eHealth governance, and inadequate management support. Accordingly, these have negatively impacted on patient data use and quality of patient care in Uganda.
Lopinavir Plus Nucleoside Reverse-transcriptase Inhibitors, Lopinavir Plus Raltegravir, or Lopinavir Monotherapy for Second-line Treatment of HIV (EARNEST): 144-week Follow-up Results From a Randomised Controlled Trial
(Elsevier, 2018-01) Hakim, G. James; Thompson, Jennifer; Kityo, Cissy; Hoppe, Anne; Kambugu, Andrew; van Oosterhout, J Joep; Lugemwa, Abbas; Siika, Abraham; Mwebaze, Raymond; Mweemba, Aggrey; Abongomera, George; Thomason, J Margaret; Easterbrook, Philippa; Mugyenyi, Peter; Walker, A Sarah
Background Millions of HIV-infected people worldwide receive antiretroviral therapy (ART) in programmes using WHO-recommended standardised regimens. Recent WHO guidelines recommend a boosted protease inhibitor plus raltegravir as an alternative second-line combination. We assessed whether this treatment option offers any advantage over the standard protease inhibitor plus two nucleoside reverse-transcriptase inhibitors (NRTIs) second-line combination after 144 weeks of follow-up in typical programme settings. Methods We analysed the 144-week outcomes at the completion of the EARNEST trial, a randomised controlled trial done in HIV-infected adults or adolescents in 14 sites in five sub-Saharan African countries (Uganda, Zimbabwe, Malawi, Kenya, Zambia). Participants were those who were no longer responding to non-NRTI-based first-line ART, as assessed with WHO criteria, confirmed by viral-load testing. Participants were randomly assigned to receive a ritonavir-boosted protease inhibitor (lopinavir 400 mg with ritonavir 100 mg, twice per day) plus two or three clinician selected NRTIs (protease inhibitor plus NRTI group), protease inhibitor plus raltegravir (400 mg twice per day; protease inhibitor plus raltegravir group), or protease inhibitor monotherapy (plus raltegravir induction for first 12 weeks, re-intensified to combination therapy after week 96; protease inhibitor monotherapy group). Randomisation was by computer-generated randomisation sequence, with variable block size. The primary outcome was viral load of less than 400 copies per mL at week 144, for which we assessed non-inferiority with a one-sided α of 0·025, and superiority with a two-sided α of 0·025. The EARNEST trial is registered with ISRCTN, number 37737787. Findings Between April 12, 2010, and April 29, 2011, 1837 patients were screened for eligibility, of whom 1277 patients were randomly assigned to an intervention group. In the primary (complete-case) analysis at 144 weeks, 317 (86%) of 367 in the protease inhibitor plus NRTI group had viral loads of less than 400 copies per mL compared with 312 (81%) of 383 in the protease inhibitor plus raltegravir group (p=0·07; lower 95% confidence limit for difference 10·2% vs specified non-inferiority margin 10%). In the protease inhibitor monotherapy group, 292 (78%) of 375 had viral loads of less than 400 copies per mL; p=0·003 versus the protease inhibitor plus NRTI group at 144 weeks. There was no difference between groups in serious adverse events, grade 3 or 4 adverse events (total or ART-related), or events that resulted in treatment modification. Interpretation Protease inhibitor plus raltegravir offered no advantage over protease inhibitor plus NRTI in virological efficacy or safety. In the primary analysis, protease inhibitor plus raltegravir did not meet non-inferiority criteria. A regimen of protease inhibitor with NRTIs remains the best standardised second-line regimen for use in programmes in resource-limited settings.
Neurocognitive Function at the First-Line Failure and on the Second-Line Antiretroviral Therapy in Africa
(Wolters Kluwer Health, Inc., 2016-04-15) Kambugu, Andrew; Thompson, Jennifer; Hakim, James; Tumukunde, Dinah; van Oosterhout, Joep J.; Mwebaze, Raymond; Hoppe, Anne; Abach, James; Kwobah, Charles
Objective: To assess neurocognitive function at the first-line antiretroviral therapy failure and change on the second-line therapy. Design: Randomized controlled trial was conducted in 5 sub-Saharan African countries. Methods: Patients failing the first-line therapy according to WHO criteria after .12 months on non-nucleoside reverse transcriptase inhibitors-based regimens were randomized to the second-line therapy (open-label) with lopinavir/ritonavir (400 mg/100 mg twice daily) plus either 2–3 clinician-selected nucleoside reverse transcriptase inhibitors, raltegravir, or as monotherapy after 12-week induction with raltegra vir. Neurocognitive function was tested at baseline, weeks 48 and 96 using color trails tests 1 and 2, and the Grooved Pegboard test. Test results were converted to an average of the 3 individual test z-scores. Results: A total of 1036 patients (90% of those .18 years enrolled at 13 evaluable sites) had valid baseline tests (58% women, median: 38 years, viral load: 65,000 copies per milliliter, CD4 count: 73 cells per cubic millimeter). Mean (SD) baseline z-score was 22.96 (1.74); lower baseline z-scores were independently associated with older age, lower body weight, higher viral load, lower hemoglobin, less education, fewer weekly working hours, previous central nervous system disease, and taking fluconazole (P , 0.05 in multivariable model). Z-score was increased by mean (SE) of +1.23 (0.04) after 96 weeks on the second-line therapy (P , 0.001; n = 915 evaluable), with no evidence of difference between the treatment arms (P = 0.35). Conclusions: Patients in sub-Saharan Africa failing the first-line therapy had low neurocognitive function test scores, but performance improved on the second-line therapy. Regimens with more central nervous system-penetrating drugs did not enhance neurocognitive recovery indicating this need not be a primary consideration in choosing a second-line regimen.
Uganda’s experience in Ebola virus disease outbreak preparedness, 2018–2019
(BMC, 2020) Aceng, Jane Ruth; Ario, Alex R.; Muruta, Allan N.; Makumbi, Issa; Nanyunja, Miriam; Komakech, Innocent; Bakainaga, Andrew N.; Talisuna, Ambrose O.; Mwesigye, Collins; Mpairwe, Allan M.; Tusiime, Jayne B.; Lali, William Z.; Katushabe, Edson; Ocom, Felix; Kaggwa, Mugagga; Bongomin, Bodo; Kasule, Hafisa; Mwoga, Joseph N.; Sensasi, Benjamin; Mwebembezi, Edmund; Katureebe, Charles; Sentumbwe, Olive; Nalwadda, Rita; Mbaka, Paul; Fatunmbi, Bayo S.; Nakiire, Lydia; Lamorde, Mohammed; Walwema, Richard; Kambugu, Andrew; Nanyondo, Judith; Okware, Solome; Ahabwe, Peter B.; Nabukenya, Immaculate; Kayiwa, Joshua; Wetaka, Milton M.; Kyazze, Simon; Kwesiga, Benon; Kadobera, Daniel; Bulage, Lilian; Nanziri, Carol; Monje, Fred; Aliddeki, Dativa M.; Ntono, Vivian; Gonahasa, Doreen; Nabatanzi, Sandra; Nsereko, Godfrey; Nakinsige, Anne; Mabumba, Eldard; Lubwama, Bernard; Sekamatte, Musa; Kibuule, Michael; Muwanguzi, David; Amone, Jackson; Upenytho, George D.; Driwale, Alfred; Seru, Morries; Sebisubi, Fred; Akello, Harriet; Kabanda, Richard; Mutengeki, David K.; Bakyaita, Tabley; Serwanjja, Vivian N.; Okwi, Richard; Okiria, Jude; Ainebyoona, Emmanuel; Opar, Bernard T.; Mimbe, Derrick; Kyabaggu, Denis; Ayebazibwe, Chrisostom; Sentumbwe, Juliet; Mwanja, Moses; Ndumu, Deo B.; Bwogi, Josephine; Balinandi, Stephen; Nyakarahuka, Luke; Tumusiime, Alex; Kyondo, Jackson; Mulei, Sophia; Lutwama, Julius; Kaleebu, Pontiano; Kagirita, Atek; Nabadda, Susan; Oumo, Peter; Lukwago, Robinah; Kasozi, Julius; Masylukov, Oleh; Kyobe, Henry Bosa; Berdaga, Viorica; Lwanga, Miriam; Opio, Joe C.; Matseketse, David; Eyul, James; Oteba, Martin O.; Bukirwa, Hasifa; Bulya, Nulu; Masiira, Ben; Kihembo, Christine; Ohuabunwo, Chima; Antara, Simon N.; Owembabazi, Wilberforce; Okot, Paul B.; Okwera, Josephine; Amoros, Isabelle; Kajja, Victoria; Mukunda, Basnet S.; Sorela, Isabel; Adams, Gregory; Shoemaker, Trevor; Klena, John D.; Taboy, Celine H.; Ward, Sarah E.; Merrill, Rebecca D.; Carter, Rosalind J.; Harris, Julie R.; Banage, Flora; Nsibambi, Thomas; Ojwang, Joseph; Kasule, Juliet N.; Stowell, Dan F.; Brown, Vance R.; Zhu, Bao-Ping; Homsy, Jaco; Nelson, Lisa J.; Tusiime, Patrick K.; Olaro, Charles; Mwebesa, Henry G.; Woldemariam, Yonas Tegegn
Since the declaration of the 10th Ebola Virus Disease (EVD) outbreak in DRC on 1st Aug 2018, several neighboring countries have been developing and implementing preparedness efforts to prevent EVD cross-border transmission to enable timely detection, investigation, and response in the event of a confirmed EVD outbreak in the country. We describe Uganda’s experience in EVD preparedness. : On 4 August 2018, the Uganda Ministry of Health (MoH) activated the Public Health Emergency Operations Centre (PHEOC) and the National Task Force (NTF) for public health emergencies to plan, guide, and coordinate EVD preparedness in the country. The NTF selected an Incident Management Team (IMT), constituting a National Rapid Response Team (NRRT) that supported activation of the District Task Forces (DTFs) and District Rapid Response Teams (DRRTs) that jointly assessed levels of preparedness in 30 designated high-risk districts representing category 1 (20 districts) and category 2 (10 districts). The MoH, with technical guidance from the World Health Organisation (WHO), led EVD preparedness activities and worked together with other ministries and partner organisations to enhance community-based surveillance systems, develop and disseminate risk communication messages, engage communities, reinforce EVD screening and infection prevention measures at Points of Entry (PoEs) and in high-risk health facilities, construct and equip EVD isolation and treatment units, and establish coordination and procurement mechanisms. As of 31 May 2019, there was no confirmed case of EVD as Uganda has continued to make significant and verifiable progress in EVD preparedness. There is a need to sustain these efforts, not only in EVD preparedness but also across the entire spectrum of a multi-hazard framework. These efforts strengthen country capacity and compel the country to avail resources for preparedness and management of incidents at the source while effectively cutting costs of using a “fire-fighting” approach during public health emergencies.