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Piloting At-birth Point of Care HIV Testing Strategies in Kenya

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ClinicalTrials.gov Identifier: NCT03435887
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sarah Kessler, PhD, MPH, University of Kansas Medical Center

Brief Summary:
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be evaluated from 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Alere q HIV-1/2 Detect for point of care infant testing Behavioral: GeneXpert HIV-1 Qual for point of care infant testing Behavioral: HIV DNA PCR testing (Standard of Care) Not Applicable

Detailed Description:

Testing HIV-exposed infants by polymerase chain reaction (PCR) testing at 6 weeks is often not early enough to mitigate the substantial mortality peak that occurs around 2-3 months of age. Initial testing at birth would foster more rapid identification of infants with intrauterine (IU) infection and speed up the initiation of antiretroviral therapy (ART) for HIV-positive infants. Consequently, Kenya introduced new early infant diagnosis guidelines recommending at-birth (0-2 weeks) virologic testing in addition to the SOC tests at 6 weeks (6 - <24 weeks), 6 months and 12 months. POC testing performed in the clinic setting can potentially further reduce the time to diagnosis. Investigators will pilot test the implementation, performance, and cost-effectiveness of two POC test systems (Xpert HIV-1 Qual, Alere q HIV-1/2 Detect) in samples from neonates (at-birth test) and older infants (6-week test) in four government hospitals in Kenya.

In the formative phase of the study, interviews will be conducted with parents, providers and community members regarding benefits and concerns about the implementation of at-birth and POC testing. Interviews with parents (pregnant women living with HIV and their partners if available) will focus on the impact for the child and family. Interviews with providers who would carry out POC testing at each site (maternity nurses, mentor mothers, hospital laboratory staff) will highlight issues of training, logistics and implementation. Interviews with community members (parents of HIV-exposed infants, community health workers, community leaders) in surrounding communities will elicit attitudes and suggestions regarding the potential for POC HIV testing in hard to access communities. Investigators will develop a codebook with typical exemplars for each theme, calculating the frequency and distribution of themes within the larger topic areas. The study team will rapidly review themes to inform the POC pilot.

In the clinical phase the investigators will pilot at-birth and POC infant testing strategies in four hospitals. Sites will be randomized to pilot Xpert HIV-1 Qual (n=2) or Alere q HIV-1/2 Detect (n=2), both targeting the at-birth and 6-week testing points. A second blood sample will be collected at each time point to be tested by SOC laboratory-based HIV DNA PCR, which will correspond with the Kenya government's 2016 guidelines that recommend adding an at-birth test to the EID schedule. At-birth samples will ideally be collected within 24 hours of delivery and results communicated to the mother with counseling prior to discharge from maternity. The expected due dates of exposed infant will be tracked to encourage mothers who deliver outside the hospital to return for infant testing within two weeks postnatal. Infants enrolled in this pilot will be tracked until HIV results at birth and 6 weeks postnatal have been provided by POC and standard PCR, or until ART is initiated for HIV-positive infants. Investigators will assess user uptake, age at notification of HIV test results, age of ART initiation among HIV+ infants, POC machine performance, costs, and user experiences (providers will participate in a monthly focus group to discuss challenges and solutions) to inform the feasibility and optimal implementation of Kenya's 2016 at-birth test recommendation and of the mobile POC test systems for the improvement of EID outcomes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Actual Study Start Date : December 2, 2016
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Alere q HIV-1/2 Detect for point of care infant testing
POC testing with Alere q HIV-1/2 Detect at birth and 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing
Behavioral: Alere q HIV-1/2 Detect for point of care infant testing
The investigators will pilot the Alere q HIV-1/2 Detect mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth and at 6 weeks of age for analysis with Alere q HIV-1/2 Detect, with results available within 1-2 hours to enable mother notification at the same clinic visit.

Behavioral: HIV DNA PCR testing (Standard of Care)
This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital.

Active Comparator: GeneXpert HIV-1 Qual for point of care infant testing
POC testing with GeneXpert HIV-1 Qual at-birth and at 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing
Behavioral: GeneXpert HIV-1 Qual for point of care infant testing
The investigators will pilot the GeneXpert HIV-1 Qual mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth and at 6 weeks of age for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit.

Behavioral: HIV DNA PCR testing (Standard of Care)
This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital.




Primary Outcome Measures :
  1. Infant age when mother is notified of at-birth (0-2 weeks postnatal) POC and SOC test results [ Time Frame: Up to 2 weeks postnatal ]
  2. Infant age when mother is notified of 6-week (3-24 weeks postnatal) POC and SOC test results [ Time Frame: Up to 24 weeks postpartum ]

Secondary Outcome Measures :
  1. Proportion of infants testing HIV+ at birth compared to 6 weeks [ Time Frame: Week 6 ]
  2. Retention in EID services [ Time Frame: up to 24 weeks ]
    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.

  3. Sensitivity and specificity of POC test [ Time Frame: Month 12 ]
    Each pilot POC technology (Alere q HIV-1/2 Detect or Xpert HIV-1 Qual POC) will be analyzed for sensitivity and specificity against gold standard SOC HIV DNA PCR technology.

  4. POC system implementation [ Time Frame: Month 12 ]
    Number of POC tests performed successfully, versus indeterminate results or failed tests

  5. Costs [ Time Frame: Month 12 ]
    Costs of implementing each POC strategy into an existing system compared to HIV DNA PCR will be quantified.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435887


Contacts
Contact: Matthew Sandbulte, PhD msandbulte@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66160
Kenya
Kisumu County Hospital Recruiting
Kisumu, Kenya
Kombewa District Hospital Recruiting
Kombewa, Kenya
Tudor Sub-County Hospital Recruiting
Mombasa, Kenya
Rift Valley Provincial General Hospital Recruiting
Nakuru, Kenya
Sponsors and Collaborators
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Sarah Kessler, PhD University of Kansas Medical Center
Principal Investigator: Raphael Lwembe, PhD Kenya Medical Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Kessler, PhD, MPH, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03435887     History of Changes
Other Study ID Numbers: STUDY00140399
R01HD076673-04S2 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sarah Kessler, PhD, MPH, University of Kansas Medical Center:
Point of Care Testing
HIV
Pediatric HIV-exposed infants
at-birth testing
early infant diagnosis
Kenya

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases