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 volunteersQualifiers
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
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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: