Malariometric indices from Iganga, Uganda: baseline characterization in preparation of GMZ2 vaccine trial.

BACKGROUND: Malaria still remains the leading cause of childhood morbidity and mortality in Uganda. Interventions like malaria vaccines which reduce the malaria burden are needed in malaria endemic communities. There is need to establish baseline characteristics in vaccine trial study sites. This study determined the following baseline malariometric indices: spleen rates, bed net use, malaria parasitaemia and malaria episodes in an inception cohort of children aged 12 - 60 months in Iganga district, Uganda. METHODS: In a longitudinal cohort study, 748 children were enrolled with 397 in an active follow up arm and 351 in a passive arm. The children in the two arms were followed for 6 months to determine the incidence of malaria episodes. RESULTS: The overall baseline spleen rate was 8.2% (61/748) among the study participants. Of the households surveyed, about 36% reported using bed nets and almost 30% of the users had insecticide-treated nets. 274 (36.6%) of the study participants had a history of fever in the past 24 hrs at the time of the baseline survey. All participants had a peripheral blood smear for malaria parasites done at enrollment with 76.8% having the asexual form of malaria parasites. The malaria episodes per child per year were 1.5 and 0.79 in the active and passive follow up arms respectively. CONCLUSIONS: There is a high prevalence of malaria asexual parasitaemia in children below five years. The bed net usage still remains low among this population. These baseline malariometric indices have important implication for malaria control interventions.

Health service delay among pulmonary tuberculosis patients presenting to a National Referral Hospital, Kampala, Uganda: a cross sectional study.

INTRODUCTION: Delay in the diagnosis of pulmonary tuberculosis (PTB) is common in many countries in Sub-Saharan Africa. Timely diagnosis of active tuberculosis is crucial in minimizing morbidity and mortality in the community as well as nosocomial transmission in health care facilities. This study aimed at determining factors associated with health service delay in the diagnosis and initiation of treatment among new PTB patients presenting to the National Referral Hospital-Mulago. METHODS: This was a cross-sectional study among eligible new PTB patients presenting at the National referral TB treatment center Mulago hospital, between March to May 2009. The patients were consecutively recruited and interviewed using a semi-structured questionnaire to assess socio- demographic and health service factors. Multivariate logistic regression using odds ratios and 95% confidence intervals was done. RESULTS: Two hundred and sixty six newly diagnosed PTB patients were enrolled, of which 65.4% experienced health systems delay. The median health service delay was 9days (IQR=8-19). Factors associated with health service delay were: 1n-patient (OR= 4.68, 95% CI: 1.91-11.45), secondary as highest level of education attained (OR= 3.56, 95% CI: 1.18-10.74), primary as highest level of education attained (OR= 6.70, 95% CI: 2.13-21.02), presence of fever (OR= 3.28, 95% CI: 1.05-10.79), and patient delay at health facility (OR= 5.01, 95% CI: 1.33-18.9). CONCLUSION: The study found a significant proportion of Health service delay among pulmonary tuberculosis patients presenting at the referral hospital. Being an in-patient and having fever as a symptom of tuberculosis needs further attention in order to have timely diagnosis. There is need for awareness on TB especially that most of the TB symptoms present like other febrile illnesses such as malaria and needs consideration when patients present to a health facility.

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

BACKGROUND: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. METHODS: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. RESULTS: Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. CONCLUSIONS: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.