HIV/AIDS, HIV Infections, Infant Morbidity, Perinatal HIV Infection
Conditions
Keywords
HIV, POC, EID
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.
Interventions
DIAGNOSTIC_TESTPoint 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.
Sponsors
UNITAID
Elizabeth Glaser Pediatric AIDS Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
| 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 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 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 |
| 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 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 |
Countries
Zimbabwe
Outcome results
None listed