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

NCT06635642 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

BEHAVIORAL

Dichotic Interaural Intensity Difference (DIID) Training

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.

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • San Diego State University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2030-03-31
Completion
2030-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635642 on ClinicalTrials.gov