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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS, Infant Morbidity, Perinatal HIV Infection, HIV Infections

Intervention / Treatment
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* Diagnostic Test: Point of care early infant diagnosis (POC EID)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-risk infants<br>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)<br>* 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.<br>* Other names: POC EID;|
| Low-risk infants<br>Mothers did not answer affirmatively to any of the four screening questions | Diagnostic Test: Point of care early infant diagnosis (POC EID)<br>* 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.<br>* Other names: POC EID;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, POC, EID