Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

HIV Infections Clinical Trial

Official title:

Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206878
• Other study ID #: EG0206
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3316
• Est. completion date: December 31, 2020
• Est. primary completion date: July 3, 2020
• Gender: All
• Age group: N/A to 4 Days

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV/AIDS
• Infant Morbidity
• Infection
• Neonatal Infection
• Pediatric HIV Infection
• Transmission, Perinatal Infection

Intervention

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

Locations

Country	Name	City	State
Swaziland	Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital	Mbabane

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	UNITAID

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months