Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: Perinatal HIV Infection; HIV Infections; HIV/AIDS; Infant Morbidity

Treatments: Diagnostic Test: Point of care early infant diagnosis (POC EID)

Study type: Observational

Funder types: Other

Identifiers

NCT04206241

EG0219

Details and patient eligibility

About

This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.

Full description

This Unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of ART initiation for HIV-positive infants. This study will compare outcomes between HIV-exposed at high vs low risk of maternal HIV transmission. The study will also assess the impact of POC birth testing on retention in care and impact on subsequent testing at 6 weeks.

Enrollment: 278,833 patients

Sex: All

Ages: Under 48 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

HIV-exposed infants (HEI)

• All HEI who access maternity/post-natal services within 48 hours of life
• Tested for HIV at birth using the POC NAT platform
• Caregiver provides informed consent for participation

Caregivers

• Mother/caregiver of an HEI who was offered POC EID at birth
• Able to provide informed consent to participate in the study

Health workers

• All health workers working in maternity services in the study sites
• Provides informed consent to be interviewed

Key informants (laboratory managers and program leads/focal persons)

• Health managers working in the field of pediatric HIV services or PMTCT
• Provides informed consent to be interviewed

Exclusion criteria

HIV-exposed infants (HEI)

• HEI tested for HIV using conventional EID at project 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)

Caregivers

• Caregivers of HEI who cannot legally provide consent to participate in the study

Health workers

• Healthcare workers who do not make use of EID or results of EID

Key informants

• Key informants who cannot legally provide consent to participate in the study

Trial design

278,833 participants in 2 patient groups

High-risk infants

Description:

Mother answered yes to any of the following questions on a risk-screening tool: * Mother diagnosed with HIV in labor and delivery? * Mother start ART after 32 weeks' gestation? * Maternal viral load above 1000 copies/ml in the 3rd trimester? * Mother seroconvert during pregnancy? * Was the mother not adhering to ART during pregnancy?

Treatment:

Diagnostic Test: Point of care early infant diagnosis (POC EID)

Low-risk infants

Description:

Mothers did not answer affirmatively to any of the four screening questions

Treatment:

Diagnostic Test: Point of care early infant diagnosis (POC EID)