Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

NCT04206878 | Completed DMC

• 1 other identifier: EG0206
• Study Type: observational
• Target: 3,316
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV; POC; EID; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  24 months

• HIV positivity rate among 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

  24 months

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

  24 months

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

  24 months

Study Arms (1)

HIV-exposed infants (HEI) eligible for birth testing

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

Interventions

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

HIV-exposed infants (HEI) eligible for birth testing

Eligibility Criteria

• Age: Up to 4 Days
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• UNITAID: collaborator

Study Sites (1)

Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital

Mbabane, Eswatini

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Jennifer Cohn

  Elizabeth Glaser Pediatric AIDS Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: December 20, 2019
• Study Start: June 1, 2017
• Primary Completion: July 3, 2020
• Study Completion: December 31, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)