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

NCT03435887 | Completed

• 2 other identifiers: STUDY00140399R01HD076673-04S2
• Study Type: interventional
• Target: 1,999
• Locations: 2 countries
• Sites: 5

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 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.

Conditions

HIV Infections

Keywords

Point of Care Testing; HIV; Pediatric HIV-exposed infants; at-birth testing; early infant diagnosis; Kenya

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Completeness of POC and SOC tests

  up to 24 weeks postnatal

• Efficiency of POC and SOC tests

  up to 24 weeks postnatal

• Retention in EID services

  up to 24 weeks postnatal

• POC system implementation

  Month 12

• Costs

  Month 12

Study Arms (2)

Alere q HIV-1/2 Detect for point of care infant testing

ACTIVE COMPARATOR

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; Behavioral: HIV DNA PCR testing (Standard of Care)

GeneXpert HIV-1 Qual for point of care infant testing

ACTIVE COMPARATOR

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; Behavioral: HIV DNA PCR testing (Standard of Care)

Interventions

Alere q HIV-1/2 Detect for point of care infant testing BEHAVIORAL

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 (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4-8 weeks postnatal) 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.

Alere q HIV-1/2 Detect for point of care infant testing

GeneXpert HIV-1 Qual for point of care infant testing BEHAVIORAL

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 (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4 to \<24 weeks postnatal) for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit.

GeneXpert HIV-1 Qual for point of care infant testing

HIV DNA PCR testing (Standard of Care) BEHAVIORAL

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.

Alere q HIV-1/2 Detect for point of care infant testing; GeneXpert HIV-1 Qual for point of care infant testing

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kisumu County Hospital

Kisumu, Kenya

Location

Kombewa District Hospital

Kombewa, Kenya

Location

Tudor Sub-County Hospital

Mombasa, Kenya

Location

Rift Valley Provincial General Hospital

Nakuru, Kenya

Location

Related Publications (4)

• 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.

  PMID: 30701079 BACKGROUND

• 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):e0225642. doi: 10.1371/journal.pone.0225642. eCollection 2019.

  PMID: 31756242 RESULT

• 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. doi: 10.1007/s10461-018-2363-3.

  PMID: 30542834 RESULT

• Wexler C, Kamau Y, Muchoki E, Babu S, Maosa N, Maloba M, Brown M, Goggin K, Mabachi N, Gautney B, Finocchario-Kessler S. Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research. Implement Sci Commun. 2021 Aug 11;2(1):89. doi: 10.1186/s43058-021-00188-9.

  PMID: 34380567 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah Kessler, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Raphael Lwembe, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 19, 2018
• Study Start: December 2, 2016
• Primary Completion: July 1, 2019
• Study Completion: April 30, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); KE (4)