NCT04206878

Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,316 (actual)
• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation · Academic / Other
• Sex: All
• Age: 4 Days
• Healthy volunteers: —

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).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-07-03
• Completion: 2020-12-31
• First posted: 2019-12-20
• Last updated: 2021-02-05

Locations

1 site across 1 country: Eswatini