Evaluating the Feasibility of Point of Care Birth Testing... | NCT04206878

Studies
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

NCT04206878

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Status

Completed

Last Update Posted

Feb 5, 2021Actual

Enrollment

3,316Actual

Phase

Not provided

Conditions

HIV Infections
HIV/AIDS
Pediatric HIV Infection
Transmission, Perinatal Infection
Infant Morbidity
Neonatal Infection

Interventions

Point-of-care birth test

Countries

Eswatini

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jul 3, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Dec 18, 2019

First Posted Date

Dec 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2021

Last Update Posted Date

Feb 5, 2021Actual

Name	Class
UNITAID	OTHER

Description Module

Brief Summary

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).

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Point-of-care birth test	Diagnostic Test	Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	24 months

Secondary Outcomes

Measure	Description	Time Frame
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	24 months
HIV positivity rate among HEI tested at birth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

4 Days

Standard Ages

Child

Study Population

For quantitative component:

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

For qualitative component:
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 3 days after birthwho were offered POC HIV EID testing at birth

Sampling Method

Non-Probability Sample

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral