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

HIV Clinical Trial

— mHealth  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03027258
• Other study ID #: 820085-3
• Secondary ID: R21TW010252-01
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: October 13, 2017
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2017
• Source: University of Nevada, Las Vegas
• Contact: Echezona Ezeanolue, MD, MPH
• Phone: 7028952687
• Email: echezona.ezeanolue[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Hepatitis B
• HIV
• Sickle Cell Disease

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.

Locations

Country	Name	City	State
Nigeria	Catholic Caritas Foundation	Makurdi	Benue

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas	John E. Fogarty International Center (FIC)

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

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. — View Citation

Outcome

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