Skip to main content
OpenTrials
Completed

NCT Number: NCT04206878

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infant Morbidity Infections Lentivirus Infections Neonatal Infection Pediatric HIV Infection RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Transmission, Perinatal Infection Urogenital Diseases Virus Diseases

Age range

Up to 4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital

Mbabane, Eswatini

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-care birth test

Diagnostic Test

Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers

Primary outcomes

  1. Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth

    Time frame: 24 months

    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

Secondary outcomes

  1. Percent of tested HEI whose caregivers receive results of the POC EID birth testing

    Time frame: 24 months

    Number of tested HEI whose caregivers receive results of the POC EID birth testing as a proportion of the number of tested HEI

  2. HIV positivity rate among HEI tested at birth

    Time frame: 24 months

    Number of HEI testing HIV positive at birth as a proportion of the number of HEI tested at birth

  3. Number of HIV-infected infants (HII) tested at birth who are started on ART within 2 weeks of the birth test

    Time frame: 24 months

    Number of HII tested at birth started on ART within 2 weeks as a proportion of the number of HII tested at birth

  4. Percent of HEI testing HIV negative at birth who return for testing at 6-8 weeks

    Time frame: 24 months

    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

  5. Percent of HEI who test HIV negative at birth and who test positive at 6-8 weeks

    Time frame: 24 months

    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

  6. 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

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • UNITAID

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2019
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.