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

N/ACompletedNCT04206241

Elizabeth Glaser Pediatric AIDS Foundation278,833 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

278,833

Conditions

HIV/AIDS Infant Morbidity Perinatal HIV Infection HIV Infections

Interventions

Point of care early infant diagnosis (POC EID)DIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMax age: 48 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Beitbridge District Hospital

Beitbridge, Zimbabwe

Bindura Provincial Hospital

Bindura, Zimbabwe

Chegutu District Hospital

Chegutu, Zimbabwe

Norton Hospital

Chegutu, Zimbabwe

Outcomes

Primary Outcomes

Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth

Number of eligible HEI who received POC EID divided by the total number of eligible HEI

Time frame: 18 months

Secondary Outcomes

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

Number of HEI whose caregivers received results of the POC EID birth testing, divided by the number of HEI who received POC EID birth testing

Time frame: 18 months

Average number of days between sample collection of HEI and results received by caregiver

Date HEI sample collected minus date results received

Time frame: 18 months

Proportion of HEI tested at birth who are HIV positive

Number of HEI tested at birth who are HIV positive divided by the number of HEI tested at birth

Time frame: 18 months

Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test

Number of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test, divided by the number of HIV-infected infants tested at birth

Time frame: 18 months

Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive

Date of sample collection of HEI minus date of date of ART initiation on ART for infants testing HIV-positive

Time frame: 18 months

Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks

Data from ClinicalTrials.gov

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