HIV/AIDSNCT04206241
Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe
An observational study of HIV/AIDS and Infant Morbidity, run by Elizabeth Glaser Pediatric AIDS Foundation at 10 sites in Zimbabwe.
Trial summary
This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Read more about this study
- Who is it for?
- Ages Up to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Infant Morbidity, Perinatal HIV Infection
- What is being tested?
- Point of care early infant diagnosis (POC EID)
- How many people
- 278,833 participants
- Where
- 10 sitesZimbabwe
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: * HIV-exposed infants newly born at the selected sites or presenting in study sites within 48 hours after birth * Health care workers and phlebotomists who are currently employed in study sites who are involved in providing POC EID services * Laboratory managers and program leads/focal persons at the Ministry of Health * Mothers/caregivers of HEI delivered or presenting in study sites within 48 hours after birth
Who may be able to join
- HIV-exposed infants (HEI)
- All HEI who access maternity/post-natal services within 48 hours of life
- Tested for HIV at birth using the POC NAT platform
- Caregiver provides informed consent for participation
- Caregivers
- Mother/caregiver of an HEI who was offered POC EID at birth
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- Able to provide informed consent to participate in the study
- Health workers
- All health workers working in maternity services in the study sites
- Provides informed consent to be interviewed
- Key informants (laboratory managers and program leads/focal persons)
- Health managers working in the field of pediatric HIV services or PMTCT
- Provides informed consent to be interviewed
Who cannot join
- HIV-exposed infants (HEI)
- HEI tested for HIV using conventional EID at project 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)
- Caregivers
- Caregivers of HEI who cannot legally provide consent to participate in the study
Show all 10Show fewer
- Health workers
- Healthcare workers who do not make use of EID or results of EID
- Key informants
- Key informants who cannot legally provide consent to participate in the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Zimbabwe10 sites
Beitbridge District Hospital
Beitbridge
Bindura Provincial Hospital
Bindura
Chegutu District Hospital
Chegutu
Norton Hospital
Chegutu
Chiredzi District Hospital
Chiredzi
Gweru Provincial Hospital
Gweru
Victoria Falls District Hospital
Hwange
Kadoma District Hospital
Kadoma
Kwekwe General Hospital
Kwekwe
Masvingo Provincial Hospital
Masvingo
About this study
This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.
Read the detailed description
This Unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of ART initiation for HIV-positive infants. This study will compare outcomes between HIV-exposed at high vs low risk of maternal HIV transmission. The study will also assess the impact of POC birth testing on retention in care and impact on subsequent testing at 6 weeks.
- Conditions
- HIV/AIDS, Infant Morbidity, Perinatal HIV Infection, HIV Infections
- Being tested
- Point of care early infant diagnosis (POC EID)
- Keywords
- HIV, POC, EID
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care early infant diagnosis (POC EID)Diagnostic test
Also called POC EID
HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
| Study group | Role | What they receive |
|---|---|---|
| High-risk infants | Mother answered yes to any of the following questions on a risk-screening tool:
* Mother diagnosed with HIV in labor and delivery?
* Mother start ART after 32 weeks' gestation?
* Maternal viral load above 1000 copies/ml in the 3rd trimester?
* Mother seroconvert during pregnancy?
* Was the mother not adhering to ART during pregnancy? Receives: Diagnostic Test: Point of care early infant diagnosis (POC EID) | |
| Low-risk infants | Mothers did not answer affirmatively to any of the four screening questions Receives: Diagnostic Test: Point of care early infant diagnosis (POC EID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth
Number of eligible HEI who received POC EID divided by the total number of eligible HEI
Measured: 18 months
Secondary outcomes (11)
Proportion of tested HEI whose caregivers receive results of the POC EID birth testing
Number of HEI whose caregivers received results of the POC EID birth testing, divided by the number of HEI who received POC EID birth testing
Measured: 18 months
Average number of days between sample collection of HEI and results received by caregiver
Date HEI sample collected minus date results received
Measured: 18 months
Proportion of HEI tested at birth who are HIV positive
Number of HEI tested at birth who are HIV positive divided by the number of HEI tested at birth
Measured: 18 months
Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test
Number of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test, divided by the number of HIV-infected infants tested at birth
Measured: 18 months
Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive
Date of sample collection of HEI minus date of date of ART initiation on ART for infants testing HIV-positive
Measured: 18 months
Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks
Number of infants testing HIV-negative at birth who return for testing at 6-8 weeks, divided by the number of infants who tested HIV-negative at birth
Measured: 18 months
Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth
Number of infants who test HIV-positive at 6-8 weeks divided by those who tested HIV-negative at birth
Measured: 18 months
The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life
Number of infants who tested HIV-positive at birth in care at 3 and/or 6 months of life, divided by the number who tested HIV-positive at birth
Measured: 18 months
Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission
Number of HEI tested at birth who meet the criteria for high risk of vertical transmission divided by the number who meet the criteria for high risk of vertical transmission
Measured: 18 months
Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth
Number of high-risk infants according to the risk screening tool who test HIV-positive at birth, divided by the number of high-risk infants according to the risk screening tool
Measured: 18 months
Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth
Number of low-risk infants according to the risk screening tool who test HIV-positive at birth, divided by the number of low-risk infants according the risk screening tool
Measured: 18 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 Jan 2018
- Primary completion1 Nov 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- 278,833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID
- Responsible party
- Sponsor
- Investigators
- Agnes Mahomva, MBCHB, MPH, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation - Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206241
- Sponsor's protocol ID
- EG0219
- Status last verified
- Aug 2021
- First submitted
- 18 Dec 2019
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe
- ClinicalTrials.gov ID
- NCT04206241
- Acronym / sponsor ID
- EG0219
- Conditions
- HIV/AIDS, Infant Morbidity, Perinatal HIV Infection, HIV Infections
- Keywords
- HIV, POC, EID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278,833 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- UNITAID
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (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, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.
Detailed description
This Unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of ART initiation for HIV-positive infants. This study will compare outcomes between HIV-exposed at high vs low risk of maternal HIV transmission. The study will also assess the impact of POC birth testing on retention in care and impact on subsequent testing at 6 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk infants | – | Diagnostic Test: Point of care early infant diagnosis (POC EID)Mother answered yes to any of the following questions on a risk-screening tool: * Mother diagnosed with HIV in labor and delivery? * Mother start ART after 32 weeks' gestation? * Maternal viral load above 1000 copies/ml in the 3rd trimester? * Mother seroconvert during pregnancy? * Was the mother not adhering to ART during pregnancy? |
| Low-risk infants | – | Diagnostic Test: Point of care early infant diagnosis (POC EID)Mothers did not answer affirmatively to any of the four screening questions |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * HIV-exposed infants newly born at the selected sites or presenting in study sites within 48 hours after birth * Health care workers and phlebotomists who are currently employed in study sites who are involved in providing POC EID services * Laboratory managers and program leads/focal persons at the Ministry of Health * Mothers/caregivers of HEI delivered or presenting in study sites within 48 hours after birth
Key inclusion criteria (13 listed)
- HIV-exposed infants (HEI)
- All HEI who access maternity/post-natal services within 48 hours of life
- Tested for HIV at birth using the POC NAT platform
- Caregiver provides informed consent for participation
- Caregivers
Key exclusion criteria (10 listed)
- HIV-exposed infants (HEI)
- HEI tested for HIV using conventional EID at project 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)
- 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 early infant diagnosis (POC EID)Also: POC EIDHIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing. | Diagnostic test | High-risk infants, Low-risk infants |
Primary outcome
Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth
Time frame: 18 months
Number of eligible HEI who received POC EID divided by the total number of eligible HEI
11 secondary outcomes
Proportion of tested HEI whose caregivers receive results of the POC EID birth testing
Time frame: 18 months
Average number of days between sample collection of HEI and results received by caregiver
Time frame: 18 months
Proportion of HEI tested at birth who are HIV positive
Time frame: 18 months
Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test
Time frame: 18 months
Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive
Time frame: 18 months
Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks
Time frame: 18 months
Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth
Time frame: 18 months
The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life
Time frame: 18 months
Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission
Time frame: 18 months
Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth
Time frame: 18 months
Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth
Time frame: 18 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 18 Aug 2021.
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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.
Agnes Mahomva, MBCHB, MPH principal investigator
Elizabeth Glaser Pediatric AIDS Foundation - Zimbabwe
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Infant Morbidity, run by Elizabeth Glaser Pediatric AIDS Foundation at 10 sites in Zimbabwe.
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 13 inclusion and 10 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Zimbabwe. 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?
Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth (time frame: 18 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 18 Aug 2021.