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NCT07165639

The Eswatini Study on Neurocognitive Performance in Adolescents Living With HIV

Not yet recruiting Last updated 15 September 2025
What this trial tests

trial in HIV (Human Immunodeficiency Virus) in 80 participants. Not yet recruiting.

Timeline
30 November 2025
Primary endpoint
31 May 2026
31 May 2026

Quick facts

Lead sponsorEswatini Nazarene Health Institutions
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment80
Start date30 November 2025
Primary completion31 May 2026
Estimated completion31 May 2026
Sites1 location across Eswatini

Conditions studied

Sponsor

Eswatini Nazarene Health Institutions

Who can join

Adults 13 to 19, any sex, with HIV (Human Immunodeficiency Virus). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for HIV (Human Immunodeficiency Virus)

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Other Eswatini Nazarene Health Institutions trials

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Data sources for this page

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