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

Not Applicable

• Conditions: Hepatitis B; HIV; Sickle Cell Disease
• Interventions: Other: mHealth

• Registration Number: NCT03027258
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-23
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-17
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	mHealth	mHealth intervention

Primary Outcome Measures

Name	Time	Method
Acceptability	6 months	The proportion of enrolled pregnant women who accept to use the smart card for their health care services
Reach	6 months	Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
Effectiveness	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	6 months	Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.

Trial Locations

Locations (1)

Catholic Caritas Foundation; 🇳🇬 Makurdi, Benue, Nigeria