Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya
Abstract Background Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants’ first 2–3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40814-019-0402-0 |
| _version_ | 1818014459011006464 |
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| author | Matthew R. Sandbulte Brad J. Gautney May Maloba Catherine Wexler Melinda Brown Natabhona Mabachi Kathy Goggin Raphael Lwembe Niaman Nazir Thomas A. Odeny Sarah Finocchario-Kessler |
| author_facet | Matthew R. Sandbulte Brad J. Gautney May Maloba Catherine Wexler Melinda Brown Natabhona Mabachi Kathy Goggin Raphael Lwembe Niaman Nazir Thomas A. Odeny Sarah Finocchario-Kessler |
| author_sort | Matthew R. Sandbulte |
| collection | DOAJ |
| description | Abstract Background Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants’ first 2–3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis. Sustainable scale-up and optimal utility in Kenya and other high-prevalence countries depend on robust implementation studies in diverse clinical settings. Methods We will pilot the implementation of birth testing by HIV DNA PCR, as well as two POC testing systems (Xpert HIV-1 Qual [Xpert] and Alere q HIV-1/2 Detect [Alere q]), on specimens collected from Kenyan infants at birth (0 to 2 weeks) and 6 weeks (4 to < 24 weeks) postnatal. The formative phase will inform optimal implementation of birth testing and two POC testing technologies. Qualitative interviews with stakeholders (providers, parents of HIV-exposed infants, and community members) will assess attitudes, barriers, and recommendations to optimize implementation at their respective sites. A non-blinded pilot study at four Kenyan hospitals (n = 2 Xpert, n = 2 Alere q platforms) will evaluate infant HIV POC testing compared with standard of care HIV DNA PCR testing in both the birth and 6-week windows. Objectives of the pilot are to assess uptake, efficiency, quality, implementation variables, user experiences of birth testing with both POC testing systems or with HIV DNA PCR, and costs. Discussion This study will generate data on the clinical impact and feasibility of adding HIV testing at birth utilizing POC and traditional PCR HIV testing strategies in resource-limited settings. Data from this pilot will inform the optimal implementation of Kenya’s birth testing guidelines and of POC testing systems for the improvement of EID outcomes. Trial registration ClinicalTrials.gov, NCT03435887. Registered 26 February 2018. |
| first_indexed | 2024-04-14T06:44:51Z |
| format | Article |
| id | doaj.art-80883774eaee4020bb16f7939035cea5 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-14T06:44:51Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-80883774eaee4020bb16f7939035cea52022-12-22T02:07:12ZengBMCPilot and Feasibility Studies2055-57842019-01-015111010.1186/s40814-019-0402-0Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in KenyaMatthew R. Sandbulte0Brad J. Gautney1May Maloba2Catherine Wexler3Melinda Brown4Natabhona Mabachi5Kathy Goggin6Raphael Lwembe7Niaman Nazir8Thomas A. Odeny9Sarah Finocchario-Kessler10Department of Family Medicine, University of Kansas Medical CenterGlobal Health InnovationsGlobal Health InnovationsDepartment of Family Medicine, University of Kansas Medical CenterDepartment of Family Medicine, University of Kansas Medical CenterDepartment of Family Medicine, University of Kansas Medical CenterHealth Services and Outcomes Research, Children’s Mercy Hospitals and ClinicsCentre for Virus Research, Kenya Medical Research InstituteDepartment of Preventive Medicine and Public Health, University of Kansas Medical CenterUniversity of Missouri–Kansas City School of MedicineDepartment of Family Medicine, University of Kansas Medical CenterAbstract Background Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants’ first 2–3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis. Sustainable scale-up and optimal utility in Kenya and other high-prevalence countries depend on robust implementation studies in diverse clinical settings. Methods We will pilot the implementation of birth testing by HIV DNA PCR, as well as two POC testing systems (Xpert HIV-1 Qual [Xpert] and Alere q HIV-1/2 Detect [Alere q]), on specimens collected from Kenyan infants at birth (0 to 2 weeks) and 6 weeks (4 to < 24 weeks) postnatal. The formative phase will inform optimal implementation of birth testing and two POC testing technologies. Qualitative interviews with stakeholders (providers, parents of HIV-exposed infants, and community members) will assess attitudes, barriers, and recommendations to optimize implementation at their respective sites. A non-blinded pilot study at four Kenyan hospitals (n = 2 Xpert, n = 2 Alere q platforms) will evaluate infant HIV POC testing compared with standard of care HIV DNA PCR testing in both the birth and 6-week windows. Objectives of the pilot are to assess uptake, efficiency, quality, implementation variables, user experiences of birth testing with both POC testing systems or with HIV DNA PCR, and costs. Discussion This study will generate data on the clinical impact and feasibility of adding HIV testing at birth utilizing POC and traditional PCR HIV testing strategies in resource-limited settings. Data from this pilot will inform the optimal implementation of Kenya’s birth testing guidelines and of POC testing systems for the improvement of EID outcomes. Trial registration ClinicalTrials.gov, NCT03435887. Registered 26 February 2018.http://link.springer.com/article/10.1186/s40814-019-0402-0HIVEarly infant diagnosisPoint-of-care testingBirth testingImplementation |
| spellingShingle | Matthew R. Sandbulte Brad J. Gautney May Maloba Catherine Wexler Melinda Brown Natabhona Mabachi Kathy Goggin Raphael Lwembe Niaman Nazir Thomas A. Odeny Sarah Finocchario-Kessler Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya Pilot and Feasibility Studies HIV Early infant diagnosis Point-of-care testing Birth testing Implementation |
| title | Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya |
| title_full | Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya |
| title_fullStr | Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya |
| title_full_unstemmed | Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya |
| title_short | Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya |
| title_sort | infant hiv testing at birth using point of care and conventional hiv dna pcr an implementation feasibility pilot study in kenya |
| topic | HIV Early infant diagnosis Point-of-care testing Birth testing Implementation |
| url | http://link.springer.com/article/10.1186/s40814-019-0402-0 |
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