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

University of Kansas

Status: Completed

Conditions: HIV Infections

Treatments: 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)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03435887

R01HD076673-04S2 (U.S. NIH Grant/Contract)

STUDY00140399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,999 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,999 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Behavioral: HIV DNA PCR testing (Standard of Care)

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

GeneXpert HIV-1 Qual for point of care infant testing

Active Comparator group

Description:

POC testing with GeneXpert HIV-1 Qual at-birth and at 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing

Treatment:

Behavioral: HIV DNA PCR testing (Standard of Care)

Behavioral: GeneXpert HIV-1 Qual for point of care infant testing