Plain English Summary
Background and study aims
People infected with the human immunodeficiency virus (HIV) are more likely to have hearing loss, as shown by some previous studies. However, there is no consensus about the age of hearing impairment, type of hearing loss and the real role of characteristics such as viral load (amount of virus in the blood) and the T CD4 cell count (number of an important type of cells of defense). The aim of this study is to assess the hearing status of children with HIV.
Who can participate?
Children with HIV aged 18 months to 11 years treated at a university hospital in Brazil, and children without HIV for comparison
What does the study involve?
Information on ear complaints (like ear infection, ear pain, difficulty in hearing, tinnitus, difficulty in word discrimination, and feeling of fullness in the ear), type and duration of antiretroviral therapy, viral load, and CD4+ cell count are obtained from the child’s caregiver. An ear examination and hearing test are performed.
What are the possible benefits and risks of participating?
The main benefit for the children involved was the early detection of hearing loss. The risks for participants were a little pain during the ear examination and hearing test if they moved their head.
Where is the study run from?
Hospital of the Federal University of Maranhão (Brazil)
When is the study starting and how long is it expected to run for?
April 2015 to September 2018
Who is funding the study?
FAPEMA (Fundação de Amparo à Pesquisa e ao Desenvolvimento Científico e Tecnológico do Estado do Maranhão)
Who is the main contact?
Prof. Janaína Pulcherio
Transient evoked otoacoustic emission in children infected with human immunodeficiency virus
HIV causes hearing loss.
Ethical Research Committee of Health Ministry of Brazil, Barão de Itapary Street, number 227, District: CENTER, São Luís, Maranhão, Brazil, Tel: +55 (98)2109-1250, Email: email@example.com, 07/08/2015, protocol number 1.175.254/2015
Cross-sectional observational study
Primary study design
Secondary study design
Cross sectional study
Patient information sheet
Data on complaints (like otorrhea, ear pain, difficulty in hearing, tinnitus, difficulty in word discrimination, and feeling of fullness in the ear), type and duration of antiretroviral therapy, viral load, and CD4+ cell count were obtained from the caregiver. Otoscopy and transient evoked otoacoustic emission (TEOAE) testing were then performed.
Primary outcome measure
Assessed at a single timpepoint:
1. Otologic complaints (like otorrhea, ear pain, difficulty in hearing, tinnitus, difficulty in word discrimination, and feeling of fullness in the ear) assessed using caregiver interview
2. Ear anatomy assessed using otoscopy
3. Hearing assessed using transient evoked otoacoustic emission (TEOAE) testing
Secondary outcome measures
Assessed at a single timpepoint:
1. Viral load, assessed using caregiver interview (the last test performed)
2. CD4+ cell count, assessed using caregiver interview (the last test performed)
3. Details of anti-retroviral therapy, assessed using caregiver interview
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Children living with HIV aged 18 months to 11 years
2. Attending the Hospital of the Federal University of Maranhão, in Northeast Brazil
Target number of participants
Participant exclusion criteria
1. Family history of deafness
2. Consanguineous parents
3. Psychomotor developmental delay due to neurological disease
4. Craniofacial anomalies
6. Hospitalization to a neonatal intensive care unit
8. Treatment with chemotherapy
9. Perinatal co-infection (toxoplasmosis, rubella, cytomegalovirus, syphilis, herpes, HTLV-1, or viral hepatitis B and C), acute infection (external or middle ear)
10. Child uncooperative or aggressive
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Hospital of the Federal University of Maranhão
Barão de Itapary Street, number 227, District: Center
São Luís, Maranhão
District: Jardim Renascença
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The trialists intend to publish at BMC Medicine.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Janaina Pulcherio (firstname.lastname@example.org).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)