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The University of Zimbabwe College of Health Sciences (UZ-CHS) BIRTH COHORT study: rationale, design and methods.

ABSTRACT: BACKGROUND:Commencing lifelong antiretroviral therapy (ART) immediately following HIV diagnosis (Option B+), has greatly improved maternal-infant health. Thus, large and increasing numbers of HIV-infected women are on ART during pregnancy, a situation concurrently increasing numbers of HIV-exposed-uninfected (HEU) infants. Compared to their HIV-unexposed-uninfected (HUU) counterparts, HEU infants show higher rates of adverse birth outcomes, mortality, infectious/non-communicable diseases including impaired growth and neurocognitive development. There is an urgent need to understand the impact of HIV and early life ART exposures, immune-metabolic dysregulation, comorbidities and environmental confounders on adverse paediatric outcomes. METHODS:Six hundred (600) HIV-infected and 600 HIV-uninfected pregnant women ?20?weeks of gestation will be enrolled from four primary health centres in high density residential areas of Harare. Participants will be followed up as mother-infant-pairs at delivery, week(s) 1, 6, 10, 14, 24, 36, 48, 72 and 96 after birth. Clinical, socio-economic, nutritional and environmental data will be assessed for adverse birth outcomes, impaired growth, immune/neurodevelopment, vertical transmission of HIV, hepatitis-B/C viruses, cytomegalovirus and syphilis. Maternal urine, stool, plasma, cord blood, amniotic fluid, placenta and milk including infant plasma, dried blood spot and stool will be collected at enrolment and follow-up visits. The composite primary endpoint is stillbirth and infant mortality within the first two years of life in HEU versus HUU infants. Maternal mortality in HIV-infected versus -uninfected women is another primary outcome. Secondary endpoints include a range of maternal and infant outcomes. Sub-studies will address maternal stress and malnutrition, maternal-infant latent tuberculosis, Helicobacter pylori infections, immune-metabolomic dysregulation including gut, breast milk and amniotic fluid dysbiosis. DISCUSSION:The University of Zimbabwe-College of Health-Sciences-Birth-Cohort study will provide a comprehensive assessment of risk factors and biomarkers for HEU infants' adverse outcomes. This will ultimately help developing strategies to mitigate effects of maternal HIV, early-life ART exposures and comorbidities on infants' mortality and morbidity. TRIAL REGISTRATION:ClinicalTrial.gov Identifier: NCT04087239 . Registered 12 September 2019.

SUBMITTER: Duri K

PROVIDER: S-EPMC7532096 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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The University of Zimbabwe College of Health Sciences (UZ-CHS) BIRTH COHORT study: rationale, design and methods.

Duri Kerina K Gumbo Felicity Z FZ Munjoma Privilege T PT Chandiwana Precious P Mhandire Kudakwashe K Ziruma Asaph A Macpherson Andrew A Rusakaniko Simbarashe S Gomo Exnevia E Misselwitz Benjamin B Mazengera Lovemore Ronald LR

BMC infectious diseases 20201002 1

<h4>Background</h4>Commencing lifelong antiretroviral therapy (ART) immediately following HIV diagnosis (Option B+), has greatly improved maternal-infant health. Thus, large and increasing numbers of HIV-infected women are on ART during pregnancy, a situation concurrently increasing numbers of HIV-exposed-uninfected (HEU) infants. Compared to their HIV-unexposed-uninfected (HUU) counterparts, HEU infants show higher rates of adverse birth outcomes, mortality, infectious/non-communicable diseases ...[more]

PMID: 33008316

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Project description:We describe the study design and methods used in a 9-month pedometer-based worksite intervention called "ASUKI Step" conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona."ASUKI Step" was based on the theory of social support and a quasi-experimental design was used for evaluation. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Study aims were: 1) to have a minimum of 400 employee participants from each university site reach a level of 10,000 steps per day on at least 100 days (3.5 months) during the trial period; 2) to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day; 3) to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and 4) to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps."ASUKI Step" is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive. The study also evaluates the intra- and interpersonal determinants for success in the intervention and in a sub-sample of the study, changes in physical fitness and body composition during the study.Current Controlled Trials NCT01537939.

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Project description:BACKGROUND:Society demands a university education grounded on ethical principles. Education in ethics values is responsibility of universities but will not be viable unless also adopted by directly responsible agents, the teachers who work with the students. For this reason, our primary research objective was to conduct an in-depth analysis of how Health Sciences students self-perceive the ethical dimension. METHODS:A mixed research methodology with two phases, qualitative and quantitative, allowed us to address our research question from two complementary viewpoints. Conversational interviews were conducted in an intentional and purposive sample to identify a wide range of discursive representations. A questionnaire was designed based on previous studies and the topics of qualitative research. The response format for the questionnaire followed a Likert scale and modulators such as sex, age, degree and the score of a social desirability test were examined. RESULTS:After 24 conversational interviews, three main thematic blocks (coinciding with the three subscales of the questionnaire) were identified: "attitudes for harmony in human relations", "construction of the self" and "rules and regulations". A total of 246 students completed a questionnaire with 39 items. The total scores ranged from 93 to 152 points, with an average score of 122.72?±?10.64 points. Responsibility, the basic rules of education and respect were perceived as the two most important values, whereas solidarity and social participation as the least important. Results showed a significant positive linear correlation between total score on the questionnaire and age and social desirability. Age was also a significant predictor for the total score and the subscale score "rules and regulations". The students´ responses seemed to be conditioned by the degree of social desirability that they present. CONCLUSIONS:The ad-hoc questionnaire captured the maintenance of high ethical values in our college undergraduate students, which may be directly related to enhanced social desirability. The scores obtained on the questionnaire were correlated with the students' age, which may indicate that values might tend to acquire progressively more importance as students grow older. Further research is warranted to delve deeper on the determinants of professionalism and ethical decision-making in college students.

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The University of Zimbabwe College of Health Sciences (UZ-CHS) BIRTH COHORT study: rationale, design and methods.

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The University of Zimbabwe College of Health Sciences (UZ-CHS) BIRTH COHORT study: rationale, design and methods.

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