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

Nevada System of Higher Education (NSHE) logo

Nevada System of Higher Education (NSHE)

Status

Unknown

Conditions

HIV
Hepatitis B
Sickle Cell Disease

Treatments

Other: mHealth

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03027258
820085-3
R21TW010252-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

Intervention
Experimental group
Description:
mHealth intervention
Treatment:
Other: mHealth

Trial contacts and locations

0

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Central trial contact

Semiu O Gbadamosi, MD, MPH; Echezona Ezeanolue, MD, MPH

Data sourced from clinicaltrials.gov

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