HIVmHealthNCT03027258
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
A study testing mHealth in people with HIV and Sickle Cell Disease, run by University of Nevada, Las Vegas at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sickle Cell Disease, Hepatitis B
- What is being tested?
- mHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNigeria
- Study dates
- Sep 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who do not accept to have their information uploaded on the secure database
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Catholic Caritas Foundation
Makurdi, Benue State
John Olawepo, MD, MSc, +234-805 564 8788, jolawepo@ccfng.org
Echezona Ezeanolue, MD, MPH
About this study
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.
Read the 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.
- Conditions
- HIV, Sickle Cell Disease, Hepatitis B
- Being tested
- mHealth
- Keywords
- Mobile health technology
- Medical subject headings
- Anemia, Sickle Cell, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | mHealth intervention Receives: Other: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
Measured: 6 months
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.
Measured: 6 months
Adoption
Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.
Measured: 6 months
Acceptability
The proportion of enrolled pregnant women who accept to use the smart card for their health care services
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Echezona Ezeanolue, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027258
- Sponsor's protocol ID
- 820085-3
- Other IDs
- R21TW010252-01
- Acronym
- mHealth
- Status last verified
- Oct 2017
- First submitted
- 6 Jan 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23758933Gbadamosi 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.
PubMed 29335234Ezeanolue 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.
PubMed 28550003
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
- ClinicalTrials.gov ID
- NCT03027258
- Acronym / sponsor ID
- mHealth / 820085-3
- Conditions
- HIV, Sickle Cell Disease, Hepatitis B
- Keywords
- Mobile health technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Sep 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: mHealthmHealth intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not accept to have their information uploaded on the secure database
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthHBI 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. | Other | Intervention |
Primary outcome
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.
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.
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.
Acceptability
Time frame: 6 months
The proportion of enrolled pregnant women who accept to use the smart card for their health care services
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Background: PubMed 23758933Ezeanolue 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.
- Derived from this study: PubMed 29335234Gbadamosi 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.
- Derived from this study: PubMed 28550003Ezeanolue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with HIV and Sickle Cell Disease, run by University of Nevada, Las Vegas at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Echezona Ezeanolue, MD, MPH (7028952687, echezona.ezeanolue@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027258, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.