Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

February 3, 2021 updated by: Elizabeth Glaser Pediatric AIDS Foundation
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This UNITAID-funded study aims to assess feasibility and utility of birth testing, [early infant diagnosis for HIV, (EID)], using point-of-care (POC) HIV nucleic acid testing (NAT) at high volume maternity settings. Birth testing is defined as tests within 3 days of life. Outcome measures will include age at testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of anti-retroviral therapy (ART) initiation for HIV-positive infants. The study will document retention in care for those who tested positive at birth, and the percent of those who tested negative at birth who returned for six week testing. The study will also assess the feasibility and acceptability of POC birth testing using interviews with policymakers, health care workers and caregivers of HIV-exposed infants (HEI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Swaziland
      • Mbabane, Swaziland
        • Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 4 days (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For quantitative component:

  1. All HEIs newly born at the selected sites or presenting in study sites within 3 days after birth

    For qualitative component:

  2. Health care workers and phlebotomists who are currently employed in study sites who are involved in providing POC EID services
  3. Laboratory managers and program leads/focal persons at the Ministry of Health
  4. Mothers/caregivers of HEI delivered or presenting in study sites within 3 days after birthwho were offered POC HIV EID testing at birth

Description

Inclusion Criteria:

  • HIV Exposed Infants

    • Must have been newly born at the study sites or presenting in study sites within 3 days after birth
    • Tested for HIV using POC EID platform (mother or caregiver agreed to have infant tested)

  • Health Care Workers (HCWs)

    • HCWs who have used POC EID for at least three months, at project sites
    • HCWs that work directly with POC EID services at maternity providing clinical services or operating the platform
    • HCWs who consent to be interviewed
    • HCWs able to speak one of the study languages

  • Laboratory Managers and program leads/focal persons:

    • National or regional level manager or head of department whose responsibilities include EID
    • Member of a national technical working group or advisory board member working on EID
    • National level representative from the MOH
    • Laboratory managers in the 3 study sites
    • Participants 18 years and above who consent to be interviewed

  • Mothers/caregivers:

    • Mother/caregiver of an HEI who was offered POC EID at birth
    • Provides consent to participate in the study
    • Is 18 years or older, or is less than 18 years old but is legally married (and thus legally emancipated)
    • Speaks one of the study languages

Exclusion Criteria:

  • HEIs:

    • HEI tested for HIV using conventional EID at projects sites
    • HEI whose caregivers refuse birth testing
    • HEI where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia)

  • HCWs:

    • HCWs who work within project sites that do not make use of EID (i.e. HCWs who are not involved directly with EID)
    • HCWs working in non-project sites
    • HCWs who are unable to consent or do not speak a study language

  • Laboratory Managers and program leads/focal persons:

    • Inability to give consent
    • Inability to speak study language

  • Mothers/Caregivers:

    • Not eligible for POC birth testing services
    • Not able to consent
    • Does not speak English or SiSwati

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HIV-exposed infants (HEI) eligible for birth testing
All HEI live births born at, or presenting to, one of the 3 study sites, within 3 days of birth.
Diagnostic test: Point-of-care birth test
Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth
Time Frame: 24 months
Number of eligible HEI born at or presenting to pilot facilities receiving POC EID testing as a proportion of the number of HEI born or presenting to pilot facilities
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of tested HEI whose caregivers receive results of the POC EID birth testing
Time Frame: 24 months
Number of tested HEI whose caregivers receive results of the POC EID birth testing as a proportion of the number of tested HEI
24 months
HIV positivity rate among HEI tested at birth
Time Frame: 24 months
Number of HEI testing HIV positive at birth as a proportion of the number of HEI tested at birth
24 months
Number of HIV-infected infants (HII) tested at birth who are started on ART within 2 weeks of the birth test
Time Frame: 24 months
Number of HII tested at birth started on ART within 2 weeks as a proportion of the number of HII tested at birth
24 months
Percent of HEI testing HIV negative at birth who return for testing at 6-8 weeks
Time Frame: 24 months
Number of HEI testing HIV negative at birth who return for testing at 6-8 weeks as a proportion of the number of HEI testing HIV negative at birth
24 months
Percent of HEI who test HIV negative at birth and who test positive at 6-8 weeks
Time Frame: 24 months
Number of HEI who test HIV negative at birth and who test HIV positive at 6-8 weeks as a proportion of the number of HEI who test HIV negative at birth
24 months
Percent of HII testing HIV positive at birth or at 6-8 weeks in care for the first 3 and/or 6 months of life
Time Frame: 24 months
The number of HII testing HIV positive at birth or at 6-8 weeks in care for the first and/or 6 months of life as a proportion of the number of HII testing HIV positive at birth or at 6-8 week of life
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UNITAID

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jennifer Cohn, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EG0206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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