The Eswatini Study on Neurocognitive Performance in Adolescents Living With HIV

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-19
SponsorEswatini Nazarene Health Institutions

About this trial

This study explores the link between inflammatory biomarkers and neurocognitive performance in adolescents living with HIV (ALHIV) in Eswatini. Persistent HIV infection during adolescence has been associated with ongoing systemic inflammation and subsequent neurocognitive dysfunction. However, the exact nature of this relationship is not well-defined, especially in resource-limited settings where epidemiological and mechanistic data are scarce.

objectives

* To determine the prevalence of cognitive impairment among a sample of adolescents living with HIV, compared to HIV-negative adolescents in Eswatini * To assess the relationship between neurocognitive performance and current viral load status in adolescent living with HIV (ALHIV). * To examine the association between inflammation biomarkers and viral load suppression status in ALHIV. * To investigate whether adolescents with HIV experiencing neurocognitive decline exhibit a high inflammatory status.

A case-control design will be employed, involving 80 adolescents aged 13-19 years: 50 who are HIV-positive and 30 HIV-negative controls. Participants will be recruited from Baylor Manzini and Mbabane, as well as Raleigh Fitkin Memorial Hospital. Neurocognitive function will be evaluated using the Symbol Digit Modalities Test, focusing on areas such as processing speed, motor coordination, attention, and visual scanning.

Blood samples will be collected to measure key inflammatory biomarkers, including C-reactive protein (CRP), soluble CD14 (sCD14), lipopolysaccharide (LPS), soluble CD163 (sCD163), and monocyte chemoattractant protein-1 (MCP-1). Sociodemographic and clinical data will be gathered through questionnaires and medical record reviews.

Primary outcomes will include neurocognitive performance scores, while secondary outcomes will involve biomarker levels and their correlation with cognitive function. Multivariate regression models will assess associations, adjusting for confounders such as age, sex, education, and HIV disease severity. Structural equation modeling will be used to explore potential mediators in the inflammation-cognition pathway.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cases

Adolescents aged 13-19 years

HIV-positive

Undergoing antiretroviral therapy at Baylor Clinic

Disqualifiers

Exclusion Criteria

Recent (within 2 months) acute conditions: influenza, COVID-19, TB, acute gastroenteritis (as these conditions elevate CRP levels)

Chronic conditions: diabetes, hypertension, asthma

Neurological disorders: epilepsy, cerebrovascular accident, neurodegenerative diseases

Trial population

The study population will encompass all adolescents attending RFM hospitals, Baylor RFM, and Baylor Mbabane: 1. Adolescents aged 13 to 19 years who are on antiretroviral therapy (ART) and attending the Baylor clinic at RFM and Baylor Mbabane. 2. HIV-negative adolescents aged 13 to 19 years who meet the inclusion criteria and are consulting at the RFM hospital outpatient department.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: cases, HIV positive adolescent
Group B: Group: HIV-Negative Adolescents

Trial outcomes

Primary outcomes

1

Neurocognitive performance

The Symbol Digit Modalities Test (SDMT) assesses neurocognitive performance by evaluating processing speed, attention, and visual-motor coordination. Participants are required to use a key to match symbols with digits as swiftly as possible within a 90-second timeframe, with the score indicating the number of correct matches. Z-scores, which typically range from -3.0 to +3.0, are employed to interpret results in relation to age and population norms. A score of 0 denotes average performance, while scores between +1 and +3 suggest above-average cognitive abilities. Conversely, scores from -1 to -1.5 may indicate mild impairment, and those below -1.5 often highlight clinically significant deficits, particularly in adolescents.

Time frame
baseline

Secondary outcomes

1

Quantitative levels of inflammatory biomarkers.

Blood samples will be collected to assess inflammatory biomarkers, including CRP, sCD14, LPS, sCD163, and MCP-1. The typical interpretation of their levels is as follows: CRP (C-reactive protein) * Low: \<1 mg/L * Normal: 1-3 mg/L * High: \>3 mg/L sCD14 (soluble CD14) * Low: \<1000 ng/mL * Normal: 1000-1500 ng/mL * High: \>1500 ng/mL LPS (lipopolysaccharide) * Low: \<0.05 EU/mL * Normal: 0.05-0.1 EU/mL * High: \>0.1 EU/mL sCD163 (soluble CD163) * Low: \<1000 ng/mL * Normal: 1000-2000 ng/mL * High: \>2000 ng/mL MCP-1 (monocyte chemoattractant protein-1) * Low: \<100 pg/mL * Normal: 100-200 pg/mL * High: \>200 pg/mL These ranges may vary slightly depending on the assay used and the population studied, but they provide a general framework for interpreting inflammatory status.

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eswatini Nazarene Health Institutions

Lead sponsor

Baylor College of Medicine Children's Foundation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: