NCT04206241

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 278,833 (actual)
• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation · Academic / Other
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• HIV/AIDS
• Infant Morbidity
• Perinatal HIV Infection
• HIV Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point of care early infant diagnosis (POC EID)	HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-11-01
• Completion: 2019-12-31
• First posted: 2019-12-20
• Last updated: 2021-08-18

Locations

10 sites across 1 country: Zimbabwe