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临床试验/NCT03027258
NCT03027258Unknown不适用

Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome

University of Nevada, Las Vegas1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Acceptability

研究概览

简要总结

The investigators propose to adopt sustainable community networks (in this case churches) to implement an integrated community-based screening that incorporates mobile health technology (mHealth) to make prenatal test results available at the point-of-delivery to guide medical management.

详细描述

The investigators will develop and test the feasibility, acceptability, and usability of a mobile health platform that captures results for HIV, Hepatitis B virus (HBV) and sickle cell genotype obtained from participants during the Healthy Beginning Initiative (HBI) program; store data in a secure, web-based database; encrypt data on a "smart card" which is given to participants, and make these data available at the point-of-delivery using a cell-phone application to read the "smart card". Data on the web-based database can also be accessed directly using the cell phone application. Evidence exists that when clinician have maternal records available at the point of delivery, they are more likely to initiate antiretroviral prophylaxis for HIV-exposed infants, administer the first dose of hepatitis B vaccine with 24 hours for infants born to women who have positive hepatitis B surface antigen and screen infants born to mothers with sickle cell trait to allow early identification and initiation of penicillin prophylaxis for infants who have sickle cell disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women; 18 years or older enrolled in the Healthy Beginning Initiative
  • One of the three conditions - HIV, Hepatitis B, and Sickle cell trait/disease

排除标准

  • Those who do not accept to have their information uploaded on the secure database

研究组 & 干预措施

Intervention

Experimental

mHealth intervention

干预措施: mHealth (Other)

结局指标

主要结局

Acceptability

时间窗: 6 months

The proportion of enrolled pregnant women who accept to use the smart card for their health care services

Reach

时间窗: 6 months

Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.

Effectiveness

时间窗: 6 months

Effectiveness will be determined by assessing the impact of the mHealth platform on key outcomes such as screening for HIV, HBV, and sickle cell genotype, and health care utilizations for follow up visits. This will be measured by calculating the percentage of pregnant women that used the "smart card" at the point-of-delivery.

Adoption

时间窗: 6 months

Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Echezona Ezeanolue

Professor of Public Health and Pediatrics

University of Nevada, Las Vegas

研究点 (1)

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