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

NCT06635642 | Withdrawn

• 1 other identifier: 1 R01 DC022822-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the association of in utero antiretroviral therapy (ART) exposure and hearing abilities of children who were perinatally HIV-exposed, but HIV-free, stratified by timing of maternal ART initiation.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Post Treatment Dichotic Digits Performance

  A total of five trials will be presented in a sequence and there will be 10 sequences per training session. Each of the 25 consonant-vowel-consonant words or digits 1 through 10 (excluding 7) will be presented to each ear during the session. The pairs will be randomized every time, and a word will never be paired with itself. After a sequence is completed, the difficulty of the task will be adjusted, in real time, based on performance on the prior task. If the child scored 4 or 5 of 5 correct in the poorer ear, then the interaural intensity difference (IID) will be decreased by 2 dB making the task more difficult. If the child scores 0, 1, or 2 of 5 correct, then the IID will be increased by 2 dB making the task easier. Last, if the child scores 3 of 5 correct, then the IID will remain unchanged for the next sequence. Post treatment percent correct will be calculated and then compared to pre treatment percent correct.

  Intervention will be 1-2 months

Study Arms (1)

Dichotic Interaural Intensity Difference Training

EXPERIMENTAL

Behavioral: Dichotic Interaural Intensity Difference (DIID) Training

Interventions

Dichotic Interaural Intensity Difference (DIID) Training BEHAVIORAL

A total of five trials will be presented in a sequence and there will be 10 sequences per training session. Each of the 25 consonant-vowel-consonant words or digits 1 through 10 (excluding 7) will be presented to each ear during the session. The pairs will be randomized every time, and a word will never be paired with itself. After a sequence is completed, the difficulty of the task will be adjusted, in real time, based on performance on the prior task. If the child scored 4 or 5 of 5 correct in the poorer ear, then the IID will be decreased by 2 dB making the task more difficult. If the child scores 0, 1, or 2 of 5 correct, then the IID will be increased by 2 dB making the task easier. Last, if the child scores 3 of 5 correct, then the IID will remain unchanged for the next sequence.

Dichotic Interaural Intensity Difference Training

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants with delivery at \>36 weeks gestation age
• Birth weight \>2500g
• No major chromosomal anomalies, neural tube defects, seizures, HIV infection or other medical conditions that influenced neurodevelopmental outcomes and/or confounded the effects of ART and HIV exposure.

You may not qualify if:

• Child being older than the proposed age range
• Caregiver's or the child's refusal to participate

Sponsors & Collaborators

• San Diego State University: lead
• University of Kentucky: collaborator
• University of Stellenbosch: collaborator

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04