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| Name | Class |
|---|---|
| UNITAID | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk infants | Mother answered yes to any of the following questions on a risk-screening tool:
|
| |
| Low-risk infants | Mothers did not answer affirmatively to any of the four screening questions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
HIV-exposed infants (HEI)
Caregivers
Health workers
Key informants (laboratory managers and program leads/focal persons)
Exclusion Criteria:
HIV-exposed infants (HEI)
Caregivers
Health workers
Key informants
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Mahomva, MBCHB, MPH | Elizabeth Glaser Pediatric AIDS Foundation - Zimbabwe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beitbridge District Hospital | Beitbridge | Zimbabwe | ||||
| Bindura Provincial Hospital |
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|
|
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 |
| Bindura |
| Zimbabwe |
| Chegutu District Hospital | Chegutu | Zimbabwe |
| Norton Hospital | Chegutu | Zimbabwe |
| Chiredzi District Hospital | Chiredzi | Zimbabwe |
| Gweru Provincial Hospital | Gweru | Zimbabwe |
| Victoria Falls District Hospital | Hwange | Zimbabwe |
| Kadoma District Hospital | Kadoma | Zimbabwe |
| Kwekwe General Hospital | Kwekwe | Zimbabwe |
| Masvingo Provincial Hospital | Masvingo | Zimbabwe |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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