Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial
Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial
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DOI：
10.1016/s2352-3018(16)00018-7
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发表时间：
2016-05-01
期刊：
影响因子：
16.1
通讯作者：
Vermund, Sten H.
中科院分区：
文献类型：
--
作者：
Aliyu, Muktar H.;Blevins, Meridith;Vermund, Sten H.
背景抗逆转录病毒治疗（ART）和继续护理对于预防母婴艾滋病毒传播（PMTCT）至关重要。我们的目的是评估以家庭为中心，综合PMTCT的护理package.Methods的影响，在这个平行的，集群随机对照试验，我们配对12个初级和二级卫生保健设施位于农村中北部尼日利亚。通过计算机生成的序列将诊所对随机分配到干预或标准护理（对照）。接受产前护理或分娩的艾滋病毒感染妇女（及其婴儿）如果在就诊时艾滋病毒状态未知（研究没有年龄限制，但最年轻的参与者为16岁）;抗逆转录病毒预防或治疗史，但在就诊时未接受这些;或已知艾滋病毒状态但从未接受过治疗，则纳入研究。标准护理包括保健信息、选择不接受艾滋病毒检测、婴儿喂养咨询、转诊进行CD 4细胞计数和治疗、家庭服务、抗逆转录病毒预防和婴儿早期诊断。该干预方案增加了任务转移、护理点CD 4检测、母婴综合服务提供以及男性伴侣和社区参与。主要结局是开始ART的合格女性比例以及产后6周和12周时保留护理的女性及其婴儿比例（通过广义线性混合效应模型进行评估，随机效应为匹配的诊所对）。该试验注册于ClinicalTrials.gov，编号NCT 01805752。结果在2013年4月1日至2014年3月31日期间，我们招募了369名符合条件的女性（172名干预，197名对照），各组的婚姻状况，HIV诊断持续时间和距离设施相似。干预组的中位CD 4计数为424个细胞/μ L（IQR 268-606），对照组为314个细胞/μ L（245-406）（p
Background Antiretroviral therapy (ART) and retention in care are essential for the prevention of mother-to-child HIV transmission (PMTCT). We aimed to assess the effect of a family-focused, integrated PMTCT care package.Methods In this parallel, cluster-randomised controlled trial, we pair-matched 12 primary and secondary level health-care facilities located in rural north-central Nigeria. Clinic pairs were randomly assigned to intervention or standard of care (control) by computer-generated sequence. HIV-infected women (and their infants) presenting for antenatal care or delivery were included if they had unknown HIV status at presentation (there was no age limit for the study, but the youngest participant was 16 years old); history of antiretroviral prophylaxis or treatment, but not receiving these at presentation; or known HIV status but had never received treatment. Standard of care included health information, opt-out HIV testing, infant feeding counselling, referral for CD4 cell counts and treatment, home-based services, antiretroviral prophylaxis, and early infant diagnosis. The intervention package added task shifting, point-of-care CD4 testing, integrated mother and infant service provision, and male partner and community engagement. The primary outcomes were the proportion of eligible women who initiated ART and the proportion of women and their infants retained in care at 6 weeks and 12 weeks post partum (assessed by generalised linear mixed effects model with random effects for matched clinic pairs). The trial is registered with ClinicalTrials.gov, number NCT01805752.Findings Between April 1, 2013, and March 31, 2014, we enrolled 369 eligible women (172 intervention, 197 control), similar across groups for marital status, duration of HIV diagnosis, and distance to facility. Median CD4 count was 424 cells per mu L (IQR 268-606) in the intervention group and 314 cells per mu L (245-406) in the control group (p