Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

NCT ID: NCT04206878

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3316 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-12-31

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Point-of-care birth test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Point-of-care birth test

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

Intervention Type: DIAGNOSTIC_TEST

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

• Maximum Eligible Age: 4 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNITAID

OTHER

Sponsor Role: collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Cohn

Role: STUDY_DIRECTOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

Mbabane Government Hospital, Hlathikhulu Hospital, and Good Shepherd Hospital

Mbabane, , Eswatini

Countries

Eswatini

Other Identifiers

EG0206

Identifier Type: -

Identifier Source: org_study_id