This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
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
3,316
Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers
Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital
Mbabane, Eswatini
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
Time frame: 24 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 months
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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
Time frame: 24 months