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

Primary Purpose

HIV, Sickle Cell Disease, Hepatitis B

Status
Unknown status
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
mHealth
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV focused on measuring Mobile health technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Catholic Caritas FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

mHealth intervention

Outcomes

Primary Outcome Measures

Reach
Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
Effectiveness
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
Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.
Acceptability
The proportion of enrolled pregnant women who accept to use the smart card for their health care services

Secondary Outcome Measures

Full Information

First Posted
January 6, 2017
Last Updated
October 13, 2017
Sponsor
University of Nevada, Las Vegas
Collaborators
Fogarty International Center of the National Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT03027258
Brief Title
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
Acronym
mHealth
Official Title
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
Fogarty International Center of the National Institute of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sickle Cell Disease, Hepatitis B
Keywords
Mobile health technology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
mHealth intervention
Intervention Type
Other
Intervention Name(s)
mHealth
Intervention Description
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 Measure Information:
Title
Reach
Description
Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
Time Frame
6 months
Title
Effectiveness
Description
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.
Time Frame
6 months
Title
Adoption
Description
Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.
Time Frame
6 months
Title
Acceptability
Description
The proportion of enrolled pregnant women who accept to use the smart card for their health care services
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Echezona Ezeanolue, MD, MPH
Phone
7028952687
Email
echezona.ezeanolue@unlv.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Semiu O Gbadamosi, MD, MPH
Phone
7028351946
Email
semiu.gbadamosi@unlv.edu
Facility Information:
Facility Name
Catholic Caritas Foundation
City
Makurdi
State/Province
Benue
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Olawepo, MD, MSc
Phone
+234-805 564 8788
Email
jolawepo@ccfng.org
First Name & Middle Initial & Last Name & Degree
Echezona Ezeanolue, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23758933
Citation
Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
Results Reference
background
PubMed Identifier
29335234
Citation
Gbadamosi SO, Eze C, Olawepo JO, Iwelunmor J, Sarpong DF, Ogidi AG, Patel D, Oko JO, Onoka C, Ezeanolue EE. A Patient-Held Smartcard With a Unique Identifier and an mHealth Platform to Improve the Availability of Prenatal Test Results in Rural Nigeria: Demonstration Study. J Med Internet Res. 2018 Jan 15;20(1):e18. doi: 10.2196/jmir.8716.
Results Reference
derived
PubMed Identifier
28550003
Citation
Ezeanolue EE, Gbadamosi SO, Olawepo JO, Iwelunmor J, Sarpong D, Eze C, Ogidi A, Patel D, Onoka C. An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol. JMIR Res Protoc. 2017 May 26;6(5):e100. doi: 10.2196/resprot.7743.
Results Reference
derived

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

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