Auditory Research in Children Living With HIV Exposure-uninfected (ARCHIVE)

This is a non-randomized, cross-sectional study of 7-10-year-old children that will also include an observational (pre-post) clinical trial for those children who will require intervention. Children/parent pairs will be contacted during their 7-year-old visit as part of the Healthy Child Study (HCS). Collaborators include investigators from the HCS trial. They will assist in the recruitment and data sharing of children with perinatally exposed to HIV, but HIV-free (PHEF) and children HIV-unexposed and HIV-free (HUF) from the HCS. All personnel conducting the assessments will be blinded to the child's HIV exposure status. All peripheral measures of hearing (i.e., otoscopy, tympanometry, distortion product otoacoustic emissions [DPOAEs], and pure-tone audiometry) are routinely performed in clinic. Central auditory processing measures (i.e., dichotic digits testing [DDT] and speech recognition in noise) are not part of routine audiological evaluation but will not require any additional training since these measures are within the scope of work for pediatric clinical audiologists.

Audiological Evaluation: The hearing examination consists of questionnaire, otoscopy, tympanometry, pure-tone air-conduction and bone-conduction audiometry, speech recognition thresholds (SRTs), speech recognition in noise, DDT, and DPOAEs. Questionnaires, otoscopy, and tympanometry can be completed in clinic rooms but pure-tone audiometry, SRTs, DDT, speech recognition in noise, and DPOAEs will be completed in sound treated rooms. The hearing examination portion will take 60 minutes and children will be given breaks when needed. A detailed explanation of the procedures is outlined below.

Questionnaire: The detailed hearing-related health questionnaire will be administered to all participants. Questions will include: whether the child had a newborn hearing screening test, and if so, these data will be extracted from medical records to determine if they passed or failed; history of middle ear involvement; trauma to the ear(s) or head; family history of hearing loss and any other medical-related hearing history, mother/caregiver-perception of any hearing problems, noise exposure, and any previous hearing aid use. The demographic questions will include date of birth, sex, race, primary language spoken, educational level of the child, child's performance at school, caregiver's education level, occupational status, annual income, and family history of hearing loss.

Otoscopy and Tympanometry: In a designated clinic room within the Speech Therapy & Audiology Clinic at Tygerberg Hospital, an audiologist will perform an otoscopic evaluation on each ear of the child. Information about the presence of debris (e.g., cerumen) in the external ear canal, color and position of the eardrum, and presence/absence of a perforation will be noted. Tympanometry will then be performed by the audiologists. This provides information regarding the functioning of the tympanic membrane. The tympanogram will be a critical component to this proposal, because these measures will most likely identify otitis media in children and poor middle ear function will have a negative, but temporary effect on DPOAEs. If there is an active middle ear involvement based on otoscopy and tympanometry measures, testing will be discontinued, the child will be referred to the Ear, Nose and Throat (ENT) clinic within Tygerberg Hospital, and the child will be rescheduled for testing once the fluid/infection has been resolved and tympanometry is within normal limits.

Pure-tone Hearing Testing: An audiologist will perform all pure-tone audiometric testing using traditional assessment protocols. Pure-tone audiometry using supra-aural earphones will be completed. Testing will be conducted in a sound-treated booth on calibrated equipment. Air conduction (AC) thresholds will be obtained at octave frequencies from 0.25-8 kHz bilaterally. Masking will be used when appropriate. If AC thresholds are >15 decibels of hearing level (dB HL), a bone conduction (BC) transducer will be placed on the mastoid of the poorer ear, as determined by the air-conduction thresholds. BC thresholds will be determined at 0.5-4 kHz. If air bone gaps are noted, masking to obtain BC thresholds will be used at all frequencies with an air-bone gap ≥15 dB HL.