HIV Infections Clinical Trial
Official title:
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Verified date | July 2020 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework. The programmatic impact of these tools on early infant diagnosis (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing initiated at 6 weeks of age.
Status | Completed |
Enrollment | 1999 |
Est. completion date | April 30, 2020 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - HIV-positive pregnant women enrolled in PMTCT services or who deliver at the study hospitals and/or mothers with exposed infants presenting for EID prior to 24 weeks - Provide informed consent Exclusion Criteria: - HIV-positive pregnant women less than 18 years of age - HIV-positive pregnant women unable to provide informed consent - HIV-exposed infants presenting for HIV testing at > 24 weeks |
Country | Name | City | State |
---|---|---|---|
Kenya | Kisumu County Hospital | Kisumu | |
Kenya | Kombewa District Hospital | Kombewa | |
Kenya | Tudor Sub-County Hospital | Mombasa | |
Kenya | Rift Valley Provincial General Hospital | Nakuru | |
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States, Kenya,
Sandbulte MR, Gautney BJ, Maloba M, Wexler C, Brown M, Mabachi N, Goggin K, Lwembe R, Nazir N, Odeny TA, Finocchario-Kessler S. Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya. Pilot Feasibility Stud. 2019 Jan 25;5:18. doi: 10.1186/s40814-019-0402-0. eCollection 2019. — View Citation
Wexler C, Kamau Y, Halder R, Brown M, Maloba M, Mabachi N, Sandbulte M, Gautney B, Goggin K, Odeny T, Finocchario-Kessler S. "Closing the Gap": Provider Recommendations for Implementing Birth Point of Care HIV Testing. AIDS Behav. 2019 Apr;23(4):1073-1083 — View Citation
Wexler C, Maloba M, Brown M, Mabachi N, Goggin K, Gautney B, Odeny B, Finocchario-Kessler S. Factors affecting acceptance of at-birth point of care HIV testing among providers and parents in Kenya: A qualitative study. PLoS One. 2019 Nov 22;14(11):e022564 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of infants tested at birth | The proportion of infants receiving HIV testing (POC and/or PCR) during the birth testing window | 0-4 weeks | |
Primary | Proportion of infants tested at 6-weeks | The proportion of infants receiving HIV testing (POC and/or PCR) during the 6 week window | 4-12 weeks postpartum | |
Secondary | Completeness of POC and SOC tests | Proportions of birth and 6-week tests with results returned and notified to mother | up to 24 weeks postnatal | |
Secondary | Efficiency of POC and SOC tests | Measures include turnaround time (TAT) associated with key steps in POC or SOC testing: TAT from specimen collection to result availability, TAT from result availability to mother notification of results, and overall TAT from specimen collection to mother notification. | up to 24 weeks postnatal | |
Secondary | Retention in EID services | Complete retention will be measured as the proportion of infants receiving a completed sequence of at-birth test result notification, 6-week-postnatal test result notification, and antiretroviral therapy (ART) initiation if HIV-positive. | up to 24 weeks postnatal | |
Secondary | POC system implementation | Number of POC tests performed successfully, versus indeterminate results or failed tests, on each platform. Number of missed opportunities to engage infants with POC testing due to documented machine breakdown, machine error, or cartridge stockout. |
Month 12 | |
Secondary | Costs | Costs of implementing each POC strategy into an existing system compared to HIV DNA PCR will be quantified, including up-front purchase of machines and accessory equipment; site-specific training and secure equipment storage; purchase of test cartridges, including delivery and customs fees; and machine repair. | Month 12 | |
Secondary | Infant age at notification of HIV test results (birth and 6 week) | Infant age when mother is notified of at-birth (0-2 weeks postnatal) and 6 week (4-8 wks) POC and SOC test results | 0-8 weeks postnatal |
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