Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

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: Completed
• Conditions: HIV Infections; HIV/AIDS; Neonatal Infection; Infant Morbidity; Pediatric HIV Infection; Transmission, Perinatal Infection
• Intervention / Treatment: Diagnostic test: Point-of-care birth test

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: Observational
• Enrollment (Actual): 3316

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	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 Outcome Measures

Outcome Measure	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	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	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	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	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	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

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: UNITAID
• Investigators: Study Director: Jennifer Cohn, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): July 3, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Pediatrics; POC; EID
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID 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