HIV InfectionsNCT04206878
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
An observational study of HIV Infections and HIV/AIDS, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Eswatini.
Trial summary
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini. Read more about this study
- Who is it for?
- Ages Up to 4 days
- Conditions the study is for
- HIV Infections, HIV/AIDS, Pediatric HIV Infection
- What is being tested?
- Point-of-care birth test
- How many people
- 3,316 participants
- Where
- 1 siteEswatini
- Study dates
- 1 Jun 2017to 31 Dec 2020
- Phase
- Observational
- 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 Up to 4 days
- All sexes
- Child
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Eswatini1 site
Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital
Mbabane
About this study
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
Read the 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).
- Conditions
- HIV Infections, HIV/AIDS, Pediatric HIV Infection, Transmission, Perinatal Infection, Infant Morbidity, Neonatal Infection
- Being tested
- Point-of-care birth test
- Keywords
- HIV, POC, EID, Pediatrics
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care birth testDiagnostic test
Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Point-of-care birth test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth
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
Measured: 24 months
Secondary outcomes (6)
Percent of tested HEI whose caregivers receive results of the POC EID birth testing
Number of tested HEI whose caregivers receive results of the POC EID birth testing as a proportion of the number of tested HEI
Measured: 24 months
HIV positivity rate among HEI tested at birth
Number of HEI testing HIV positive at birth as a proportion of the number of HEI tested at birth
Measured: 24 months
Number of HIV-infected infants (HII) tested at birth who are started on ART within 2 weeks of the birth test
Number of HII tested at birth started on ART within 2 weeks as a proportion of the number of HII tested at birth
Measured: 24 months
Percent of HEI testing HIV negative at birth who return for testing at 6-8 weeks
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
Measured: 24 months
Percent of HEI who test HIV negative at birth and who test positive at 6-8 weeks
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
Measured: 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
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jun 2017
- Primary completion3 Jul 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID
- Responsible party
- Sponsor
- Investigators
- Jennifer Cohn, Study director, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206878
- Sponsor's protocol ID
- EG0206
- Status last verified
- Feb 2021
- First submitted
- 11 Mar 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
- ClinicalTrials.gov ID
- NCT04206878
- Acronym / sponsor ID
- EG0206
- Conditions
- HIV Infections, HIV/AIDS, Pediatric HIV Infection, Transmission, Perinatal Infection, Infant Morbidity, Neonatal Infection
- Keywords
- HIV, POC, EID, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,316 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- UNITAID
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- 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.
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-exposed infants (HEI) eligible for birth testing | – | Diagnostic Test: Point-of-care birth testAll HEI live births born at, or presenting to, one of the 3 study sites, within 3 days of birth. |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (19 listed)
- HIV Exposed Infants
- Health Care Workers (HCWs)
- Laboratory Managers and program leads/focal persons:
- Mothers/caregivers:
Key exclusion criteria (15 listed)
- HEIs:
- HCWs:
- Laboratory Managers and program leads/focal persons:
- Mothers/Caregivers:
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 |
|---|---|---|
| Point-of-care birth testCollect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers | Diagnostic test | HIV-exposed infants (HEI) eligible for birth testing |
Primary outcome
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
6 secondary outcomes
Percent of tested HEI whose caregivers receive results of the POC EID birth testing
Time frame: 24 months
HIV positivity rate among HEI tested at birth
Time frame: 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
Percent of HEI testing HIV negative at birth who return for testing at 6-8 weeks
Time frame: 24 months
Percent of HEI who test HIV negative at birth and who test positive at 6-8 weeks
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- 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.
Jennifer Cohn study director
Elizabeth Glaser Pediatric AIDS Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV/AIDS, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Eswatini.
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 19 inclusion and 15 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: finished, as of the sponsor's last update on 5 Feb 2021. 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 Eswatini. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2021.