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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV/AIDS; Infant Morbidity; Perinatal HIV Infection
• Intervention / Treatment: Diagnostic test: Point of care early infant diagnosis (POC EID)

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.

• Study Type: Observational
• Enrollment (Actual): 278833

Contacts and Locations

Study Locations

• Zimbabwe
  • Beitbridge, Zimbabwe
    • Beitbridge District Hospital
  • Bindura, Zimbabwe
    • Bindura Provincial Hospital
  • Chegutu, Zimbabwe
    • Chegutu District Hospital
  • Chegutu, Zimbabwe
    • Norton Hospital
  • Chiredzi, Zimbabwe
    • Chiredzi District Hospital
  • Gweru, Zimbabwe
    • Gweru Provincial Hospital
  • Hwange, Zimbabwe
    • Victoria Falls District Hospital
  • Kadoma, Zimbabwe
    • Kadoma District Hospital
  • Kwekwe, Zimbabwe
    • Kwekwe General Hospital
  • Masvingo, Zimbabwe
    • Masvingo Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• HIV-exposed infants newly born at the selected sites or presenting in study sites within 48 hours after birth
• Health care workers and phlebotomists who are currently employed in study sites who are involved in providing POC EID services
• Laboratory managers and program leads/focal persons at the Ministry of Health
• Mothers/caregivers of HEI delivered or presenting in study sites within 48 hours after birth

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High-risk infants; 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?	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.; Other Names: POC EID
Low-risk infants; Mothers did not answer affirmatively to any of the four screening questions	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.; Other Names: POC EID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months
Average number of days between sample collection of HEI and results received by caregiver	Date HEI sample collected minus date results received	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	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	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	18 months
Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks	Number of infants testing HIV-negative at birth who return for testing at 6-8 weeks, divided by the number of infants who tested HIV-negative at birth	18 months
Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth	Number of infants who test HIV-positive at 6-8 weeks divided by those who tested HIV-negative at birth	18 months
The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life	Number of infants who tested HIV-positive at birth in care at 3 and/or 6 months of life, divided by the number who tested HIV-positive at birth	18 months
Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission	Number of HEI tested at birth who meet the criteria for high risk of vertical transmission divided by the number who meet the criteria for high risk of vertical transmission	18 months
Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth	Number of high-risk infants according to the risk screening tool who test HIV-positive at birth, divided by the number of high-risk infants according to the risk screening tool	18 months
Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth	Number of low-risk infants according to the risk screening tool who test HIV-positive at birth, divided by the number of low-risk infants according the risk screening tool	18 months

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: UNITAID
• Investigators: Principal Investigator: Agnes Mahomva, MBCHB, MPH, Elizabeth Glaser Pediatric AIDS Foundation - Zimbabwe

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (ACTUAL): December 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: HIV; POC; EID
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: EG0219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No