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CTN 315: The KIND Study

Kids Imaging and Neurocognitive Development Study

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About the study (objectives)

Thanks to advances in treatment, many women living with HIV can get pregnant with minimal risk of giving birth to a child who has the virus. While most children who are HIV-exposed but uninfected (CHEU) are in good health, it is unclear how exposure to HIV and antiretroviral therapy (ART) during pregnancy could impact their brain development and long-term health.

CTN 315 aims to examine brain development and long-term behavioural and cognitive function of CHEU by comparing brain structure and function between CHEU and children who are HIV-unexposed and uninfected (CHUU). The study hopes to address clinically important knowledge gaps that affect the long-term health of CHEU.

About the disease/condition (background/context)

In Canada, 200-300 babies are born to women living with HIV each year, and almost all of these children are HIV-negative despite exposure to the virus, thanks to ART and transmission prevention programs. A number of observational studies suggest that HEU children may have a higher risk of health issues such as increased morbidity and mortality in the first year of life, higher likelihood of pre-term birth, increased risk of infection, and mental health impairments. The increasing number of CHEU could result in more instances of health issues, impacting on public health and the CHEU’s ability to reach their full potential.

Study Approach (methodology)

This multi-site prospective clinical study will conduct cognitive, behavioural, and brain imaging (MRI and MR spectroscopy) investigations of 180 CHEU and 65 CHUU to better characterize overall brain function and explore links between brain function and behavioural deficits and changes in specific brain regions.

Eligibility criteria

Inclusion criteria:

For CHEU participants

  • Aged 6-10 years at time of enrolment
  • Mother was living with HIV during pregnancy
  • Mother was on ART for at least 4 weeks during pregnancy

For CHUU participants

  • Aged 6-10 years at time of enrolment
  • Mother who was HIV-negative during pregnancy

Exclusion criteria:

  • Presence of braces or other metal implants that would be prohibitive to MRI
  • Previous developmental or neurological condition unrelated to HIV/ART exposure (e.g. stroke, Trisomy 21) with residual function
  • For CHEU participants: Those diagnosed with autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) can participate in the study
  • For CHUU participants: Those diagnosed with autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) cannot participate in the study
  • Significant maternal smoking, regular alcohol consumption, or use of illicit drugs during pregnancy that are known to influence the unborn child’s brain development (e.g. cocaine use)

Participating Sites

Toronto

Hospital for Sick Children
Dr. Ari Bitnun
555 University Avenue
Toronto, Ontario
Phone: 416-813-6268
Email: ari.bitnun@sickkids.ca

Study Coordinator
Cheryl Arneson
cheryl.arneson@sickkids.ca

Ottawa

Children’s Hospital of Eastern Ontario (CHEO)
Dr. Jason Brophy
401 Smyth Road
Ottawa, Ontario
Phone: 613-737-7600 x2651
jbrophy@cheo.on.ca

Study Coordinator
Jen Bowes
jbowes@cheo.on.ca

Additional Information

For more information about the study, please contact the principal investigator.

Principal Investigator

Dr. Lena Serghides
University Health Network
Princess Margaret Cancer Research Tower
101 College Street, Room 10-359
Toronto, Ontario
Phone: 416-634-8175
Email: lena.serghides@utoronto.ca

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Research for treatments, prevention and a cure