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

NCT04206241 | Completed

• 1 other identifier: EG0219
• Study Type: observational
• Target: 278,833
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

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

Keywords

HIV; POC; EID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  18 months

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

  18 months

• Proportion of HEI tested at birth who are HIV positive

  18 months

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

  18 months

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

  18 months

Study Arms (2)

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)

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)

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.

Also known as: POC EID

High-risk infants; Low-risk infants

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• UNITAID: collaborator

Study Sites (10)

Beitbridge District Hospital

Beitbridge, Zimbabwe

Location

Bindura Provincial Hospital

Bindura, Zimbabwe

Location

Chegutu District Hospital

Chegutu, Zimbabwe

Location

Norton Hospital

Chegutu, Zimbabwe

Location

Chiredzi District Hospital

Chiredzi, Zimbabwe

Location

Gweru Provincial Hospital

Gweru, Zimbabwe

Location

Victoria Falls District Hospital

Hwange, Zimbabwe

Location

Kadoma District Hospital

Kadoma, Zimbabwe

Location

Kwekwe General Hospital

Kwekwe, Zimbabwe

Location

Masvingo Provincial Hospital

Masvingo, Zimbabwe

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Agnes Mahomva, MBCHB, MPH

  Elizabeth Glaser Pediatric AIDS Foundation - Zimbabwe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: January 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 31, 2019
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

ZI (10)