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

Completed

• Conditions: HIV Infections; Infant Morbidity; HIV/AIDS; Perinatal HIV Infection
• Interventions: Diagnostic Test: Point of care early infant diagnosis (POC EID)

• Registration Number: NCT04206241
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-11-01
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Study Completion: 2019-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278833

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-risk infants	Point of care early infant diagnosis (POC EID)	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?
Low-risk infants	Point of care early infant diagnosis (POC EID)	Mothers did not answer affirmatively to any of the four screening questions

Primary Outcome Measures

Name	Time	Method
Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth	18 months	Number of eligible HEI who received POC EID divided by the total number of eligible HEI

Secondary Outcome Measures

Name	Time	Method
Average number of days between sample collection of HEI and results received by caregiver	18 months	Date HEI sample collected minus date results received
Proportion of HEI tested at birth who are HIV positive	18 months	Number of HEI tested at birth who are HIV positive divided by the number of HEI tested at birth
Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks	18 months	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
The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life	18 months	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
Proportion of tested HEI whose caregivers receive results of the POC EID birth testing	18 months	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
Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test	18 months	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
Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive	18 months	Date of sample collection of HEI minus date of date of ART initiation on ART for infants testing HIV-positive
Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth	18 months	Number of infants who test HIV-positive at 6-8 weeks divided by those who tested HIV-negative at birth
Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission	18 months	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
Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth	18 months	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
Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth	18 months	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

Trial Locations

Locations (10)

Gweru Provincial Hospital; 🇿🇼 Gweru, Zimbabwe

Masvingo Provincial Hospital; 🇿🇼 Masvingo, Zimbabwe

Victoria Falls District Hospital; 🇿🇼 Hwange, Zimbabwe

Norton Hospital; 🇿🇼 Chegutu, Zimbabwe

Kadoma District Hospital; 🇿🇼 Kadoma, Zimbabwe

Chegutu District Hospital; 🇿🇼 Chegutu, Zimbabwe

Kwekwe General Hospital; 🇿🇼 Kwekwe, Zimbabwe

Chiredzi District Hospital; 🇿🇼 Chiredzi, Zimbabwe

Beitbridge District Hospital; 🇿🇼 Beitbridge, Zimbabwe

Bindura Provincial Hospital; 🇿🇼 Bindura, Zimbabwe