Universal newborn hearing screening in Kenya using smartphone tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the accuracy of smartphone otoacoustic emissions screening compared with conventional methods in infants aged 5 to 7 months. It aims to determine the incidence of otitis media with effusions and abnormal hearing screening findings in infants with and without HIV exposure. Infants and their biological mothers will be followed for 6 months with three clinic visits, using both smartphone and standard devices to assess hearing and ear health. The findings may clarify the utility of smartphone screening as a scalable tool in this population. Exploratory analyses will consider whether HIV exposure modifies risk for otitis media with effusions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Is at least 18 years old
* Is a biological mother for the infant participant
* Willing to disclose HIV status with confirmation from medical record
* Planning to reside in the study catchment for the next 6 months

Infants must meet all of the following criteria:

* Age 5 to 7 months
* at least one patent ear canal

Exclusion Criteria:

• Unwilling to provide locator information for contact

Where it's running

• Mathare North Health Centre
  Nairobi, Kenya Recruiting

Study contacts

• Principal investigator: Sarah Benki-Nugent, PhD — University of Washington
• Study coordinator: Sarah Benki-Nugent, PhD
• Email: benki@u.washington.edu
• Phone: 206-685-9713

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.