Clinical trial NCT03435887: Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Official title: Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Point of Care Testing
HIV
Pediatric HIV-exposed infants
at-birth testing
early infant diagnosis
Kenya
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-02-19
Enrollment: 1999
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 intervention phase the investigators will pilot at-birth and POC infant testing strategies in four hospitals over a continuous 12-month enrollment period. 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.

Eligibility 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

Primary outcomes:
measure: Proportion of infants tested at birth
timeFrame: 0-4 weeks
measure: Proportion of infants tested at 6-weeks
timeFrame: 4-12 weeks postpartum
Secondary outcomes:
measure: Completeness of POC and SOC tests
timeFrame: up to 24 weeks postnatal
measure: Efficiency of POC and SOC tests
timeFrame: up to 24 weeks postnatal
measure: Retention in EID services
timeFrame: up to 24 weeks postnatal
measure: POC system implementation
timeFrame: Month 12
measure: Costs
timeFrame: Month 12
measure: Infant age at notification of HIV test results (birth and 6 week)
timeFrame: 0-8 weeks postnatal
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kisumu
country: Kenya
facility: Kisumu County Hospital
city: Kombewa
country: Kenya
facility: Kombewa District Hospital
city: Mombasa
country: Kenya
facility: Tudor Sub-County Hospital
city: Nakuru
country: Kenya
facility: Rift Valley Provincial General Hospital
Study officials:
affiliation: University of Kansas Medical Center
name: Sarah Kessler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Raphael Lwembe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):e0225642. doi: 10.1371/journal.pone.0225642. eCollection 2019.
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. doi: 10.1007/s10461-018-2363-3.
citation: 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.