Clinical trial NCT04206878: Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
Official title: Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HIV/AIDS
Pediatric HIV Infection
Transmission, Perinatal Infection
Infant Morbidity
Neonatal Infection
Keywords: HIV
POC
EID
Pediatrics
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: UNITAID
First posted: 2019-12-20
Enrollment: 3316
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth
timeFrame: 24 months
Secondary outcomes:
measure: Percent of tested HEI whose caregivers receive results of the POC EID birth testing
timeFrame: 24 months
measure: HIV positivity rate among HEI tested at birth
timeFrame: 24 months
measure: Number of HIV-infected infants (HII) tested at birth who are started on ART within 2 weeks of the birth test
timeFrame: 24 months
measure: Percent of HEI testing HIV negative at birth who return for testing at 6-8 weeks
timeFrame: 24 months
measure: Percent of HEI who test HIV negative at birth and who test positive at 6-8 weeks
timeFrame: 24 months
measure: 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
timeFrame: 24 months
Other outcomes:
Locations:
city: Mbabane
country: Swaziland
facility: Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Jennifer Cohn
role: STUDY_DIRECTOR
References: