Assessment of the Impact of HIV Infection an Anti-retroviral Therapy (ART) on the Cardiometabolic Health of Pregnant Mothers and Their Offspring
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Assessment of changes in cardiovascular risk profile during pregnancy in pregnant HIV positive women on ARTs
研究概览
简要总结
The Human Immunodeficiency Virus (HIV) has been recently linked to increased risk for cardiovascular diseases (CVDs). The prevalence of cardiovascular diseases and its risk factor, hypertension, are very high in African communities especially in the working age group which also happens to have the bulk of young female adults in the reproductive age. Hypertension in African children is becoming a real cause for concern though its etiology remains elusive. Thanks to antiretroviral therapy (ART) use, many more infected persons live long enough to reproduce, consequently, an increasing number of children are being born to mothers who are infected with HIV. Could it be that in utero exposure of these children to HIV/ART contribute in programming them for increased risk for cardiovascular diseases thus making them more vulnerable to hypertension in childhood and adulthood? This study is aimed at exploring the possible association of in utero exposure to the HIV/ART environment and an increased risk for cardiovascular disease.
详细描述
I. Sample size calculation The number of participants required to show statistical significance is based on previously published studies in which vascular function was assessed in HIV patients (Agu et al., 2019). An error probability (α) of 0.05, and power (1- β) of 0.80 and an average effect size (d) of 0.5 were used to calculate the sample size (n= 64 persons). Assuming a 25% drop out rate, we will use N = (64 + (64*25)/100) = 80 mothers/group to ensure that we will have enough sample size/group to show statistical significance. Total number of participating mothers will therefore be 160 (80 cases and 80 controls) and their offspring - 160.
II. Ethical approval Ethical consent and permission to carry out the research project will be obtained from the Faculty of Health Sciences Research and Ethics Committee (HRSEC) at Walter Sisulu University (WSU). The purpose of the study will be explained to women attending the antenatal clinic in the Umtata General and Nelson Mandela Academic Hospitals, Mthatha, Eastern Cape Province. Pregnant women who will be willing to participate will be required to sign informed consent forms to participate in the study and to allow their children to participate in the study from birth.
III. Study design A prospective case control study design will be used in this study.
IV. Selection criteria Sub-Saharan women with singleton uncomplicated 11-14 week old pregnancies, be HIV positive for the case group and HIV negative for the control group. Pregnant women with type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health condition will be excluded from the study
V. Experimental Plan
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cases: sub-Saharan women with singleton uncomplicated 11-14 week old pregnancies, be HIV positive and have been on ARTs for at least four months before pregnancy.
- •Controls: 11-14 week old pregnant HIV negative women.
排除标准
- •Pregnant women with type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health.
结局指标
主要结局
Assessment of changes in cardiovascular risk profile during pregnancy in pregnant HIV positive women on ARTs
时间窗: March 2021 to March 2022
Cardiovascular risk will be assessed in pregnant
Assessment of of CVD risk in offspring of HIV positive mothers on ARTs
时间窗: March 2021 to March 2022
Cardiovascular risk will be assessed in the offspring of HIV positive mothers on ART at three time point: at birth, three, twelve and twenty months after birth.
次要结局
未报告次要终点