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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03027258
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 17, 2017
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Echezona Ezeanolue, University of Nevada, Las Vegas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Sickle Cell Disease Hepatitis B Other: mHealth Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
Study Start Date : September 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
mHealth intervention
Other: mHealth
HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.

Primary Outcome Measures :
  1. Reach [ Time Frame: 6 months ]
    Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.

  2. Effectiveness [ Time Frame: 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.

  3. Adoption [ Time Frame: 6 months ]
    Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.

  4. Acceptability [ Time Frame: 6 months ]
    The proportion of enrolled pregnant women who accept to use the smart card for their health care services

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03027258

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Contact: Echezona Ezeanolue, MD, MPH 7028952687
Contact: Semiu O Gbadamosi, MD, MPH 7028351946

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Catholic Caritas Foundation Recruiting
Makurdi, Benue, Nigeria
Contact: John Olawepo, MD, MSc    +234-805 564 8788   
Principal Investigator: Echezona Ezeanolue, MD, MPH         
Sponsors and Collaborators
University of Nevada, Las Vegas
John E. Fogarty International Center (FIC)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Echezona Ezeanolue, Professor of Public Health and Pediatrics, University of Nevada, Las Vegas Identifier: NCT03027258     History of Changes
Other Study ID Numbers: 820085-3
R21TW010252-01 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Echezona Ezeanolue, University of Nevada, Las Vegas:
Mobile health technology

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Virus Diseases
Liver Diseases
Digestive System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human