Mother Kevin Postgraduate Medical School

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Adverse Pregnancy Outcomes Associated With Moderate Elevations in Blood Pressure or Blood Glucose in Ugandan Women: A Prospective Cohort Study
(Elsevier, 2021-05) Milln, Jack; Nakabuye, Betty; Natamba, Barnabas; Sekitoleko, Isaac; Mubiru, Michael; Namara, Arthur; Tumwesigire, Samuel; Tino, Salome; Mirembe, Mandy; Kakanda, Ayoub; Agaba, Brian; Nansubuga, Faridah; Zaake, Daniel; Ayiko, Ben; Kalema, Herbert; Nakubulwa, Sarah; Sekikubo, Musa; Nakimuli, Annette; Webb, L. Emily; Nyirenda, J. Maffat
BACKGROUND: The association between overt hypertension and diabetes and adverse pregnancy outcomes is well documented. Recentevidence suggests that even moderate elevations in blood pressure or blood glucose may confer a significant risk in a dose-dependent manner. However, these studies have primarily been undertaken in white populations in high-income settings. Hypertension and diabetes are emerging as major public health issues in sub-Saharan Africa as the region undergoes rapid urbanization. It is therefore important to understand how such noncommunicable conditions contribute to pregnancy outcomes in these populations. OBJECTIVE: This study aimed to determine the association between stage 1 hypertension or fasting blood glucose in the gestational diabetes mellitus-range and adverse pregnancy outcomes in Uganda, and to describe the effects of other contributing factors such as maternal obesity. STUDY DESIGN: This was a prospective cohort study of 2857 women at 5 major hospitals in urban and semiurban central Uganda. Women were enrolled at 24 to 28 weeks’ gestation. Data about the maternal demographics, anthropometrics, fasting venous blood glucose, blood pressure, and pregnancy outcomes were collected. Moderate elevations in blood pressure and blood glucose were defined using the latest American College of Cardiology and American Heart Association definition of stage 1 hypertension and the World Health Organization’s criteria for fasting blood glucose in the gestational diabetes mellitus-range. The primary outcomes of interest were perinatal death and large birthweight for gestational age, and the secondary outcomes were preterm birth, cesarean delivery, and neonatal admission. A multivariable logistic regression analysis was used. RESULTS: Stage 1 hypertension increased the odds of perinatal death by more than 2-fold (adjusted odds ratio, 2.68; 95% confidence interval, 1.36−5.29), with a positive but insignificant association with preterm birth. Hyperglycemia in the gestational diabetes mellitus-range was associated with cesarean delivery only (adjusted odds ratio, 1.65; 95% confidence interval, 1.20−2.27). Maternal obesity increased the risk of having large birthweight babies (adjusted odds ratio, 2.30; 95% confidence interval, 1.74−3.02), a cesarean delivery (adjusted odds ratio, 2.75; 95% confidence interval, 2.17−3.48), and neonatal admission (adjusted odds ratio, 1.63; 95% confidence interval, 1.16−2.30). CONCLUSION: Moderate elevations in blood pressure and maternal obesity are stronger predictors of adverse maternal and neonatal outcomes than moderate elevations in blood glucose levels and should be the focus of intervention in these resource-poor settings. Further research is needed to determine the cost-effectiveness of identifying and managing moderate elevations in blood pressure and maternal obesity
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.)
Community Knowledge of and Attitudes Toward Epilepsy in Rural and Urban Mukono District, Uganda: A Cross-Sectional Study
(Elsevier, 2016-01) Kaddumukasa, Mark; Kakooza, Angelina; Kayima, James; Kaddumukasa, N. Martin; Ddumba, Edward; Mugenyi, Levi; Furlan, Anthony; Lhatoo, Samden; Sajatovic, Martha; Katabira, Elly
Introduction: The lack of adequate knowledge poses a barrier in the provision of appropriate treatment and care of patients with epilepsy within the community. The purpose of this study was to determine the knowledge of and attitude towards epilepsy and its treatment by community dwellers in Uganda. Methods: A cross sectional population survey was conducted in urban and rural Mukono district, central Uganda. Adult respondents through multistage stratified sampling were interviewed about selected aspects of epilepsy knowledge, attitudes, and perception using a pretested structured questionnaire. Results: Ninety-one percent of the study respondents had heard or read about epilepsy or knew someone who had epilepsy and had seen someone having a seizure. Thirty-seven percent of the respondents did not know the cause of epilepsy, while 29% cited genetic causes. About seventeen percent of the subjects believed that epilepsy is contagious. Only 5.6% (21/377) of the respondents would take a patient with epilepsy to hospital for treatment. Conclusion: Adults in Mukono are very acquainted with epilepsy but have many erroneous beliefs about the condition. Negative attitudes are pervasive within communities in Uganda. The national epilepsy awareness programs need to clarify the purported modes of transmission of epilepsy, available treatment options, and care offered during epileptic seizures during community sensitizations in our settings.
A Descriptive Epidemiological Study on Stroke in Kampala, Uganda: A Hospital Based Study
(Pan African Association of Neurological Sciences, 2012) Nakibuuka, Jane; Nyakoojo, Abwooli; Namale, Alice; Blondin, Nicholas A.; Ddumba, Edward
Background Basic stroke features are hardly known in sub-Saharan countries, and no data are available in Uganda. Objective To characterize patients presenting with clinical stroke to Mulago Hospital. Design Descriptive epidemiological study. Setting Mulago National referral Hospital in Kampala, Uganda. Participants Patients presenting with clinical stroke from 1st July to 30th November 2006. Patients with confirmed stroke had comprehensive assessments for stroke risk factors. Results Among 139 patients presenting with clinical stroke, 127 had a non-contrast head CT scan and 12 died prior to scan. Eighty five patients were confirmed to have stroke while 42 had non stroke lesions. Among patients with confirmed stroke, 77.6% had ischemic stroke while 22.4% had hemorrhagic stroke. The mean age for all stroke patients was 62.2 ± 16.2 yrs and 51.8% were men. The incidence of both ischemic and hemorrhagic stroke increased with age. Atherosclerotic stroke was the most common ischemic stroke etiology, observed in 43.5% patients with ischemic stroke, while intraparenchymal hemorrhage was the most common hemorrhagic stroke etiology, observed in 78.9% of patients with hemorrhagic stroke. Hypertension was the commonest risk factor with more than 50% of all stroke patients reporting a history of hypertension, and more than half found to have blood pressure greater than 140/90 mm Hg. Physical inactivity and hypercholesterolemia were encountered in more than 36% and 30% of patients with ischemic and haemorrhagic strokes respectively.
Development of Phenotypic and Genotypic Resistance to Antiretroviral Therapy in the UNAIDS HIV Drug Access Initiative – Uganda
(Wolters Kluwer Health, Inc., 2003-07) Weidlea, J. Paul; Downingb, Robert; Sozic, Catherine; Mwebaze, Raymond; Rukundo, Gideon; Malamba, Samuel; Respessa, Richard; Hertogsf, Kurt; Larderg, Brendan; Ochola, Dorothy; Mermin, Jonathan; Badara Sambk, Badara; Lackritz, Eve
Objective: We describe phenotypic drug resistance, response to therapy, and geno-typic mutations among HIV-infected patients in Uganda taking antiretroviral medica-tions for ≥ 90 days who had a viral load ≥ 1000 copies/ml. Methods: HIV-1 group and subtype, virologic and immunologic responses to anti-retroviral therapy, phenotypic resistance to antiretroviral drugs, and associated geno-typic mutations among patients at three treatment centers in Uganda between June 1999 and August 2000 were assessed. Therapy was two nucleoside reverse tran-scriptase inhibitors (NRTIs) or highly active antiretroviral therapy (HAART). Results: All HIV identified was HIV-1, group M, subtypes A, C, and D. Sixty-one (65%) of 94 patients with a phenotypic resistance result had evidence of phenotypic resistance including resistance to a NRTI for 51 of 92 (55%) taking NRTIs, to a non-nucleoside reverse transcriptase inhibitor (NNRTI) for nine of 16 (56%) taking NNRTIs, and to a protease inhibitor (PI) for eight of 37 (22%) taking PIs. At the time of the first specimen with resistance, the median change from baseline viral load was –0.56 log copies/ml [interquartile range (IQR), –1.47 to +0.29] and CD4+ cell count was +35 × 106 cells/l (IQR, –18 to +87). Genotypic resistance mutations, matched with phenotypic resistance assay results and drug history, were generally consistent with those seen for HIV-1, group M, subtype B infections in industrialized countries. Conclusion: Initial phenotypic resistance and corresponding genotypic mutations among patients treated in Uganda were similar to those with subtype B infections in North America and Europe. These data support policies that promote the use of HAART regimens against HIV-1, group M, non-B subtypes in a manner consistent with that used for subtype B infections.
Gestational Diabetes (GDM) Does Not Predict Large Birthweight or Perinatal Death in a Relatively Untreated Population in Uganda: A Prospective Observational Cohort Study.
(Elsevier, 2021-05) Milln, Jack; Nakabuye, Betty; Natamba, Barnabas; Sekitoleko, Isaac; Mubiru, Michael; Namara, Arthur; Tumwesigire, Samuel; Tino, Salome; Wilja, Mandy; Kakande, Ayoub; Agaba, Brian; Nansubuga, Faridah; Zaake, Daniel; Ayiko, Ben; Nakubulwa, Sarah; Sekikubo, Musa; Nakimuli, Annettee; Webb, Emily; Nyirenda, Moffat
BACKGROUND The association between overt hypertension and diabetes and adverse pregnancy outcomes is well documented. Recent evidence suggests that even moderate elevations in blood pressure or blood glucose may confer a significant risk in a dose-dependent manner. However, these studies have primarily been undertaken in white populations in high-income settings. Hypertension and diabetes are emerging as major public health issues in sub-Saharan Africa as the region undergoes rapid urbanization. It is therefore important to understand how such noncommunicable conditions contribute to pregnancy outcomes in these populations. OBJECTIVE This study aimed to determine the association between stage 1 hypertension or fasting blood glucose in the gestational diabetes mellitus-range and adverse pregnancy outcomes in Uganda, and to describe the effects of other contributing factors such as maternal obesity. STUDY DESIGN This was a prospective cohort study of 2857 women at 5 major hospitals in urban and semiurban central Uganda. Women were enrolled at 24 to 28 weeks’ gestation. Data about the maternal demographics, anthropometrics, fasting venous blood glucose, blood pressure, and pregnancy outcomes were collected. Moderate elevations in blood pressure and blood glucose were defined using the latest American College of Cardiology and American Heart Association definition of stage 1 hypertension and the World Health Organization's criteria for fasting blood glucose in the gestational diabetes mellitus-range. The primary outcomes of interest were perinatal death and large birthweight for gestational age, and the secondary outcomes were preterm birth, cesarean delivery, and neonatal admission. A multivariable logistic regression analysis was used. RESULTS Stage 1 hypertension increased the odds of perinatal death by more than 2-fold (adjusted odds ratio, 2.68; 95% confidence interval, 1.36–5.29), with a positive but insignificant association with preterm birth. Hyperglycemia in the gestational diabetes mellitus-range was associated with cesarean delivery only (adjusted odds ratio, 1.65; 95% confidence interval, 1.20–2.27). Maternal obesity increased the risk of having large birthweight babies (adjusted odds ratio, 2.30; 95% confidence interval, 1.74–3.02), a cesarean delivery (adjusted odds ratio, 2.75; 95% confidence interval, 2.17–3.48), and neonatal admission (adjusted odds ratio, 1.63; 95% confidence interval, 1.16–2.30). CONCLUSION Moderate elevations in blood pressure and maternal obesity are stronger predictors of adverse maternal and neonatal outcomes than moderate elevations in blood glucose levels and should be the focus of intervention in these resource-poor settings. Further research is needed to determine the cost-effectiveness of identifying and managing moderate elevations in blood pressure and maternal obesity
Long-Term Experience Providing Antiretroviral Drugs in a Fee-for-Service HIV Clinic in Uganda
(Wolters Kluwer Health, Inc., 2005-04-15) Kabugo, Charles; Bahendeka, Sylver; Mwebaze, Raymond; Malamba, Samuel; Katuntu, David; Downing, Robert; Mermin, Jonathan; Weidle, J. Paul
Objective: To describe the long-term experience of providing anti-retroviral (ARV) therapy, including CD4+ cell count and virologic response, at St. Francis Hospital, Nsambya, Uganda. Methods: The HIV clinic established in 1998 is a fee-for-service model where patients pay for ARVs. The care of patients who started ARVs from August 1, 1998 until October 31, 2000 was evaluated through December 31, 2002. Data were collected at the HIV clinic on standardized clinical forms. These patients had free CD4+ cell count and viral load testing performed at times determined by the physician. All persons who had ≥1 CD4+ cell count or viral load done ≥90 days after starting therapy were evaluated. Results: Three hundred twenty-one patients (49% women, 66% ARV naive, median age = 38 years, median CD4+ cell count = 79 cells/mm3, and median viral load = 249,489 copies/mL) attended the HIV clinic. Two hundred sixty-three (82%) patients returned at least once after the initial visit, of whom 54 (21%) had an interruption in therapy for >1 year. One hundred thirty-five patients were in care in 2002, 69 were known to have died (9 of whom died in 2002), and 68 were lost to follow-up. The probability of remaining alive and in care at 1 year was 0.56 (95% confidence interval [CI]: 0.50-0.61), 0.46 (95% CI: 0.41-0.51) at 2 years, 0.40 (95% CI: 0.34-0.45) at 3 years, and 0.35 (95% CI: 0.29-0.41) at 4 years. In an on-treatment analysis, the median CD4+ cell count increase during year 1 was +55 cells/mm3, +112 cells/mm3 during year 2, +142 cells/mm3 during year 3, and +131 cells/mm3 during year 4. The median log viral load change from baseline during year 1 was −1.4 copies/mL, −1.32 copies/mL during year 2, −1.9 copies/mL during year 3, and −1.51 copies/mL during year 4. Conclusions: This fee-for-service HIV clinic providing ARV treatment has successfully operated and managed patients for more than 4 years. Those who survived and remained on therapy derived long-term virologic and immunologic responses to ARV drugs in a manner similar to that observed in industrialized countries. Strategies to reduce the financial burden and other barriers to uninterrupted care as well as incentives to increase such practice models should be further explored in the African context.
Mentorship Needs at Academic Institutions in Resource-Limited Settings: A Survey at Makerere University College of Health Sciences
(BMC , CAMPUS, 4 CRINAN ST, LONDON, ENGLAND, N1 9XW, 2011-07-29) Nakanjako, Damalie; Byakika-Kibwika, Pauline; Kintu, Kenneth; Aizire, Jim; Nakwagala, Fred; Luzige, Simon; Namisi, Charles; Mayanja-Kizza, Harriet; Kamya, R Moses
Background: Mentoring is a core component of medical education and career success. There is increasing global emphasis on mentorship of young scientists in order to train and develop the next leaders in global health. However, mentoring efforts are challenged by the high clinical, research and administrative demands. We evaluated the status and nature of mentoring practices at Makerere University College of Health Sciences (MAKCHS). Methods: Pre-tested, self-administered questionnaires were sent by email to all Fogarty alumni at the MAKCHS (mentors) and each of them was requested to complete and email back the questionnaire. In addition to training level and number of mentors, the questionnaires had open-ended questions covering themes such as; status of mentorship, challenges faced by mentors and strategies to improve and sustain mentorship within MAKCHS. Similarly, open-ended questionnaires were sent and received by email from all graduate students (mentees) registered with the Uganda Society for Health Scientists (USHS). Qualitative data from mentors and mentees was analyzed manually according to the pre-determined themes. Results: Twenty- two out of 100 mentors responded (14 email and 8 hard copy responses). Up to 77% (17/22) of mentors had Master’s-level training and only 18% (4/22) had doctorate-level training. About 40% of the mentors had ≥ two mentees while 27% had none. Qualitative results showed that mentors needed support in terms of training in mentoring skills and logistical/financial support to carry out successful mentorship. Junior scientists and students reported that mentorship is not yet institutionalized and it is currently occurring in an adhoc manner. There was lack of awareness of roles of mentors and mentees. The mentors mentioned the limited number of practicing mentors at the college and thus the need for training courses and guidelines for faculty members in regard to mentorship at academic institutions. Conclusions: Both mentors and mentees were willing to improve mentorship practices at MAKCHS. There is need for institutional commitment to uphold and sustain the mentorship best practices. We recommend a collaborative approach by the stakeholders in global health promotion to build local capacity in mentoring African health professionals.
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.
An Overview Cancer Management And Prevention In Africa
(The College of Surgeons of East, Central and Southern Africa (COSECSA), 2001) Kakande, Ignatius
Poststroke Hypertension in Africa
(LIPPINCOTT WILLIAMS & WILKINS , TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, USA, PA, 19103, 2012-09-25) Kaddumukasa, Martin; Ddumba, Edward; Duncan, Pamela; Goldstein, B. Larry
Background and Purpose—Little is known about the frequency of hypertension and related knowledge in Africans who have had a stroke. The objective of this study was to determine the frequency of hypertension, its control, and associated knowledge among patients with and without a history of stroke at Uganda’s main referral hospital. Methods—Subjects with a history of stroke (n=157) were compared with stroke-free control subjects (n=149). Demographics and clinical characteristics were recorded and hypertension-related knowledge assessed by questionnaire. Multiple logistic regression including cases and control subjects was used to determine factors independently associated with blood pressure control and hypertension-related knowledge. Results—A total of 69.4% of cases versus 54.7% of control subjects were hypertensive at the time of the research visit (P=0.001). Univariable analyses showed the odds of having good blood pressure control (OR, 0.53; 95% CI, 0.33–0.84; P=0.006) and good hypertension knowledge (OR, 0.35; 95% CI, 0.22–0.56; P<0.0001) were lower in cases. Age <40 years (P=0.002), good hypertension-related knowledge (P=0.002), and poorer medication adherence (P<0.0001) were independently associated with poorer blood pressure control. Those with a history of hypertension had better hypertension related knowledge (P=0.001), but knowledge was poorer among cases (P<0.0001). Conclusion—Hypertension is common in Ugandans with and without a history of stroke. Barriers to effective blood pressure control in Uganda other than patient knowledge need to be identified
Prosthetic thrombosis and pregnancy on warfarin: Debate on mechanical mitral valve replacement in sub-Saharan Africa based on a case report
(Elsevier - International Journal of Cardiology, 2014) Ariol, Francesco; D’Arbela, Paul G.; Aloi, Francesco; Nsubuga, Martin; Grimaidi, Antonio; Ammirati, Enrico
Rheumatic heart disease (RHD) is the most common cardiovascular disease in children and young adults in the world. Echocardiographic screenings have documented a large prevalence of RHD in sub-Saharan Africa; there is, however, a great discrepancy in prevalence data due to different clinical and echocardiographic diagnostic criteria of probable or possible RHD and mean age of the screened population. Advanced valve disease requires cardiac surgery, which is not routinely available in many developing countries, as is the case of Uganda. RHD affects mainly the young of both genders. Mitral valve is the most commonly affected, and mitral regurgitation (MR) the most common manifestation. Surgical repair of rheumatic mitral lesions is complex and need for replacement is frequent. When valve replacement is planned for sub-Saharan patients, the choice between biological and mechanical prosthesis represents a major issue. Monitoring international normalized ratio (INR) to guide oral anticoagulant dosage can be expensive and difficult, particularly in rural areas, and adherence to oral anticoagulation regimens may be low, thus patients with mechanical valve prosthesis are at increased risk both for valve thrombosis and major bleeding. In female patients, moreover, the need for anticoagulation may preclude or complicate pregnancy. Keywords:
The Uganda Newborn Study (UNEST): An Effectiveness Study on Improving Newborn Health and Survival in Rural Uganda Through a Community-based Intervention Linked to Health Facilities - Study Protocol for a Cluster Randomized Controlled Trial
(BioMed Central, 2012) Waiswa, Peter; Peterson, S Stefan; Namazzi, Gertrude; Ekirapa, Kiracho Elizabeth; Naikoba, Sarah; Byaruhanga, Romano; Kiguli, Juliet; Kallander, Karin; Tagoola, Abner; Nakakeeto, Margaret; Pariyo, George
Background Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4. Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions, but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture, health system and policy environment is different. In Uganda, health outcomes are poor for both mothers and newborn babies. Policy opportunities for neonatal health include the new national Health Sector Strategic Plan, which now prioritizes newborn health including use of a community model through Village Health Teams (VHT). The aim of the present study is to adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda. Methods/Design Through formative research around evidence-based practices, and dialogue with policy and technical advisers, we constructed a home-based neonatal care package implemented by the responsible VHT member, effectively a Community Health Worker (CHW). This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas. The study is taking place in a new Demographic Surveillance Site in two rural districts, Iganga and Mayuge, in Uganda. It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHWs to visit the mother five times in her home during pregnancy and the neonatal period. Both areas benefit from a standardized strengthening of facility care for mothers and neonates. Discussion UNEST is designed to directly feed into the operationalization of maternal and newborn care in the national VHT strategy, thereby helping to inform scale-up in rural Uganda. The study is registered as a randomized controlled trial, number ISRCTN50321130.

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