Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

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

Intervention / Treatment
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* Diagnostic Test: Point-of-care birth test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 4 Days

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-exposed infants (HEI) eligible for birth testing<br>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<br>* Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, POC, EID, Pediatrics