PDF(Pubmed)
Abstract：
OBJECTIVE: Globally, the number of children/adolescents exposed to HIV but uninfected (HIV-exposed uninfected, HEU) is growing. The HEU outcomes: population-evaluation and screening strategies study was designed to provide population-level evidence of the impact of HIV and recent antiretroviral therapy regimen exposure on neurodevelopmental, hearing and mental health outcomes from infancy to adolescence.
METHODS: The study includes a prospective mother-infant cohort and cross-sectional child/youth-caregiver cohorts conducted in Kenya.Between 2021 and 2022, the study enrolled 2000 mother-infant pairs (1000 HEU and 1000 HIV-unexposed uninfected (HUU)) for longitudinal follow-up. Infants were eligible if they were aged 4-10 weeks and healthy. Mothers were eligible if their HIV status was known and were ≥18 years. Study visits are 6 monthly until the child reaches age 3 years.Cross-sectional cohorts spanning ages 3-18 years started enrolment in 2022. Target enrolment is 4400 children/youth (4000 HEU and 400 HUU). Children and youth are eligible if they are HIV negative, maternal HIV status and timing of diagnosis is known, and caregivers are ≥18 years.Data on infant/child/youth growth, neurodevelopment, mental health, morbidity and hearing are collected at enrolment using standardised tools. Dry blood spots samples are collected for telomere length assessment at baseline and yearly for the longitudinal cohort. Growth z-scores, neurodevelopmental scores, telomere length and prevalence of developmental and hearing problems will be compared between HEU/HUU populations.
RESULTS: Full cohort enrolment for the longitudinal cohort is complete and participants are in follow-up. At 1 year of age, comparing HEU to HUU neurodevelopment using the Malawi developmental assessment tool, we found that HEU infants had higher language scores and comparable scores in fine motor, gross motor and social scores. The cross-sectional cohort has enrolled over 2000 participants and recruitment is ongoing.
UNASSIGNED: Longitudinal cohort follow-up and enrolment to the cross-sectional study will be completed in June 2024.
METHODS: The study includes a prospective mother-infant cohort and cross-sectional child/youth-caregiver cohorts conducted in Kenya.Between 2021 and 2022, the study enrolled 2000 mother-infant pairs (1000 HEU and 1000 HIV-unexposed uninfected (HUU)) for longitudinal follow-up. Infants were eligible if they were aged 4-10 weeks and healthy. Mothers were eligible if their HIV status was known and were ≥18 years. Study visits are 6 monthly until the child reaches age 3 years.Cross-sectional cohorts spanning ages 3-18 years started enrolment in 2022. Target enrolment is 4400 children/youth (4000 HEU and 400 HUU). Children and youth are eligible if they are HIV negative, maternal HIV status and timing of diagnosis is known, and caregivers are ≥18 years.Data on infant/child/youth growth, neurodevelopment, mental health, morbidity and hearing are collected at enrolment using standardised tools. Dry blood spots samples are collected for telomere length assessment at baseline and yearly for the longitudinal cohort. Growth z-scores, neurodevelopmental scores, telomere length and prevalence of developmental and hearing problems will be compared between HEU/HUU populations.
RESULTS: Full cohort enrolment for the longitudinal cohort is complete and participants are in follow-up. At 1 year of age, comparing HEU to HUU neurodevelopment using the Malawi developmental assessment tool, we found that HEU infants had higher language scores and comparable scores in fine motor, gross motor and social scores. The cross-sectional cohort has enrolled over 2000 participants and recruitment is ongoing.
UNASSIGNED: Longitudinal cohort follow-up and enrolment to the cross-sectional study will be completed in June 2024.
摘要：
目标：全球，暴露于艾滋病毒但未感染的儿童/青少年人数(未感染艾滋病毒，HEU）正在增长。HEU结果：人群评估和筛查策略研究旨在提供人群水平的证据，证明HIV和近期抗逆转录病毒治疗方案暴露对神经发育的影响。从婴儿期到青春期的听力和心理健康结果。
方法：该研究包括在肯尼亚进行的前瞻性母婴队列和横断面儿童/青年照顾者队列。在2021年至2022年之间，该研究招募了2000对母婴（1000HEU和1000未暴露于HIV的未感染（HUU））进行纵向随访。如果婴儿年龄在4-10周且健康，则符合资格。如果母亲的艾滋病毒状况已知且≥18岁，则符合资格。研究访问是6个月，直到孩子达到3岁。年龄在3-18岁之间的横断面队列于2022年开始注册。目标入学率为4400名儿童/青年(4000HEU和400HUU)。如果艾滋病毒呈阴性，儿童和青年有资格，孕妇的艾滋病毒状况和诊断时机是已知的，护理人员≥18岁。婴儿/儿童/青年成长数据，神经发育，心理健康,发病率和听力在注册时使用标准化工具进行收集。收集干血斑点样品用于基线时的端粒长度评估,并且每年用于纵向组群。增长z分数，神经发育评分,将在HEU/HUU人群之间比较端粒长度和发育和听力问题的患病率。
结果：纵向队列的全部队列登记完成，参与者正在随访中。一岁时，使用马拉维发育评估工具将HEU与HUU神经发育进行比较，我们发现HEU婴儿在精细运动方面有更高的语言分数和可比的分数，总运动和社会得分。横断面队列已招募了2000多名参与者，并且正在进行招募。
■纵向队列随访和横断面研究的注册将于2024年6月完成。
方法：该研究包括在肯尼亚进行的前瞻性母婴队列和横断面儿童/青年照顾者队列。在2021年至2022年之间，该研究招募了2000对母婴（1000HEU和1000未暴露于HIV的未感染（HUU））进行纵向随访。如果婴儿年龄在4-10周且健康，则符合资格。如果母亲的艾滋病毒状况已知且≥18岁，则符合资格。研究访问是6个月，直到孩子达到3岁。年龄在3-18岁之间的横断面队列于2022年开始注册。目标入学率为4400名儿童/青年(4000HEU和400HUU)。如果艾滋病毒呈阴性，儿童和青年有资格，孕妇的艾滋病毒状况和诊断时机是已知的，护理人员≥18岁。婴儿/儿童/青年成长数据，神经发育，心理健康,发病率和听力在注册时使用标准化工具进行收集。收集干血斑点样品用于基线时的端粒长度评估,并且每年用于纵向组群。增长z分数，神经发育评分,将在HEU/HUU人群之间比较端粒长度和发育和听力问题的患病率。
结果：纵向队列的全部队列登记完成，参与者正在随访中。一岁时，使用马拉维发育评估工具将HEU与HUU神经发育进行比较，我们发现HEU婴儿在精细运动方面有更高的语言分数和可比的分数，总运动和社会得分。横断面队列已招募了2000多名参与者，并且正在进行招募。
■纵向队列随访和横断面研究的注册将于2024年6月完成。
