Background The development of a malaria vaccine remains a public health priority for sub-Saharan... more Background The development of a malaria vaccine remains a public health priority for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to be safe and immunogenic in previous studies in adults and staggered dose-escalation studies in children in The Gambia. However, genetic features and the intensity of malaria transmission may modify the safety and immune response of a vaccine.Objective We carried out a phase I, double-blind randomized controlled trial in 60 children aged 1–4 in Mozambique to evaluate the safety, reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 μg RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb proof-of-concept of efficacy study in the same population.Method Children were randomized to receive either RTS,S/AS02A or Engerix-B® vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs).Results The RTS,S/...
Keywords: Mortality/statistics; Cause of death; Statistics; Africa South of the Sahara; Banglades... more Keywords: Mortality/statistics; Cause of death; Statistics; Africa South of the Sahara; Bangladesh (source: MeSH, NLM). ... OBJECTIF: Fournir des données comparables au niveau international sur la fréquence des différentes causes de décès. MÉTHODES: Il s'agissait d'analyser les ...
Varying efficacy of intermittent preventive treatment for malaria in infants in two similar trial... more Varying efficacy of intermittent preventive treatment for malaria in infants in two similar trials: public health implications
Background: Human papillomavirus (HPV) infection is now a well-established cause of cervical canc... more Background: Human papillomavirus (HPV) infection is now a well-established cause of cervical cancer and other anogenital cancers. An association between human immunodeficiency virus (HIV) infection and higher HPV incidence and prevalence are commonly reported. This study was conducted to demonstrate HPV prevalence, genotypes and its characteristics, according to the HIV status in women from Maputo in Mozambique. Methods: A total of 233 participants with ages ranging from fourteen to forty-five were included. Cervical samples were collected, DNA extracted, and HPV genotyping was performed using the HPV Direct Flow CHIP Kit. Results: In total, 177 HIV-negative and 56 HIV-positive women were included in the analysis. The overall HPV prevalence was 63% and was significantly higher among HIV-positive women (79% versus 58% among HIV-negative women; p = 0.005). The prevalence of multiple HPV type infections was 32%. High-risk HPV types 52, 68, 35, 18 and 16 were the most frequent. A higher...
Journal of empirical research on human research ethics : JERHRE, Jul 1, 2018
Participants' understanding of key elements of a research protocol is essential to their ethi... more Participants' understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study's aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study's informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans...
Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a grow... more Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, f...
In the face of rising mortality rates from cervical cancer (CC) among women of reproductive age, ... more In the face of rising mortality rates from cervical cancer (CC) among women of reproductive age, a nationwide screening program based on visual inspection with acetic acid was introduced in Mozambique in 2009. The objective of the study is to examine the impact of per capita income on the effectiveness of school-based health education programs to promote the utilization of CC screening services. We conducted a cross-sectional study in 2013 involving 105 women randomly selected from households of different economic backgrounds. Marginal effect estimates derived from a logit model were used to explore the patterns in the effectiveness of school-based health education to promote CC screening uptake according to household per capita income, based on purchasing power parity. We found a CC screening uptake of 16.1% (95% confidence interval [CI], 9.7%-24.6%) even though 64.6% (95% CI, 54.2%-74.1%) of women had heard of it. There are important economic differentials in the effectiveness of ...
Non-tuberculous mycobacteria (NTM) can cause disease which can be clinically and radiologically u... more Non-tuberculous mycobacteria (NTM) can cause disease which can be clinically and radiologically undistinguishable from tuberculosis (TB), posing a diagnostic and therapeutic challenge in high TB settings. We aim to describe the prevalence of NTM isolation and its clinical characteristics in children from rural Mozambique. This study was part of a community TB incidence study in children <3 years of age. Gastric aspirate and induced sputum sampling were performed in all presumptive TB cases and processed for smear testing using fluorochrome staining and LED Microscopy, liquid and solid culture, and molecular identification by GenoType® Mycobacterium CM/AS assays. NTM were isolated in 26.3% (204/775) of children. The most prevalent NTM species was M. intracellulare (N = 128), followed by M. scrofulaceum (N = 35) and M. fortuitum (N = 9). Children with NTM were significantly less symptomatic and less likely to present with an abnormal chest radiograph than those with M. tuberculosis...
Background The development of a malaria vaccine remains a public health priority for sub-Saharan... more Background The development of a malaria vaccine remains a public health priority for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to be safe and immunogenic in previous studies in adults and staggered dose-escalation studies in children in The Gambia. However, genetic features and the intensity of malaria transmission may modify the safety and immune response of a vaccine.Objective We carried out a phase I, double-blind randomized controlled trial in 60 children aged 1–4 in Mozambique to evaluate the safety, reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 μg RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb proof-of-concept of efficacy study in the same population.Method Children were randomized to receive either RTS,S/AS02A or Engerix-B® vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs).Results The RTS,S/...
Keywords: Mortality/statistics; Cause of death; Statistics; Africa South of the Sahara; Banglades... more Keywords: Mortality/statistics; Cause of death; Statistics; Africa South of the Sahara; Bangladesh (source: MeSH, NLM). ... OBJECTIF: Fournir des données comparables au niveau international sur la fréquence des différentes causes de décès. MÉTHODES: Il s'agissait d'analyser les ...
Varying efficacy of intermittent preventive treatment for malaria in infants in two similar trial... more Varying efficacy of intermittent preventive treatment for malaria in infants in two similar trials: public health implications
Background: Human papillomavirus (HPV) infection is now a well-established cause of cervical canc... more Background: Human papillomavirus (HPV) infection is now a well-established cause of cervical cancer and other anogenital cancers. An association between human immunodeficiency virus (HIV) infection and higher HPV incidence and prevalence are commonly reported. This study was conducted to demonstrate HPV prevalence, genotypes and its characteristics, according to the HIV status in women from Maputo in Mozambique. Methods: A total of 233 participants with ages ranging from fourteen to forty-five were included. Cervical samples were collected, DNA extracted, and HPV genotyping was performed using the HPV Direct Flow CHIP Kit. Results: In total, 177 HIV-negative and 56 HIV-positive women were included in the analysis. The overall HPV prevalence was 63% and was significantly higher among HIV-positive women (79% versus 58% among HIV-negative women; p = 0.005). The prevalence of multiple HPV type infections was 32%. High-risk HPV types 52, 68, 35, 18 and 16 were the most frequent. A higher...
Journal of empirical research on human research ethics : JERHRE, Jul 1, 2018
Participants' understanding of key elements of a research protocol is essential to their ethi... more Participants' understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study's aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study's informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans...
Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a grow... more Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, f...
In the face of rising mortality rates from cervical cancer (CC) among women of reproductive age, ... more In the face of rising mortality rates from cervical cancer (CC) among women of reproductive age, a nationwide screening program based on visual inspection with acetic acid was introduced in Mozambique in 2009. The objective of the study is to examine the impact of per capita income on the effectiveness of school-based health education programs to promote the utilization of CC screening services. We conducted a cross-sectional study in 2013 involving 105 women randomly selected from households of different economic backgrounds. Marginal effect estimates derived from a logit model were used to explore the patterns in the effectiveness of school-based health education to promote CC screening uptake according to household per capita income, based on purchasing power parity. We found a CC screening uptake of 16.1% (95% confidence interval [CI], 9.7%-24.6%) even though 64.6% (95% CI, 54.2%-74.1%) of women had heard of it. There are important economic differentials in the effectiveness of ...
Non-tuberculous mycobacteria (NTM) can cause disease which can be clinically and radiologically u... more Non-tuberculous mycobacteria (NTM) can cause disease which can be clinically and radiologically undistinguishable from tuberculosis (TB), posing a diagnostic and therapeutic challenge in high TB settings. We aim to describe the prevalence of NTM isolation and its clinical characteristics in children from rural Mozambique. This study was part of a community TB incidence study in children <3 years of age. Gastric aspirate and induced sputum sampling were performed in all presumptive TB cases and processed for smear testing using fluorochrome staining and LED Microscopy, liquid and solid culture, and molecular identification by GenoType® Mycobacterium CM/AS assays. NTM were isolated in 26.3% (204/775) of children. The most prevalent NTM species was M. intracellulare (N = 128), followed by M. scrofulaceum (N = 35) and M. fortuitum (N = 9). Children with NTM were significantly less symptomatic and less likely to present with an abnormal chest radiograph than those with M. tuberculosis...
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