The Eswatini Study on Neurocognitive Performance in Adolescents Living With HIV

NCT07165639 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-09-15

No results posted yet for this study

Summary

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.

Conditions

  • HIV (Human Immunodeficiency Virus)

Sponsors & Collaborators

  • Baylor Foundation Eswatini

    collaborator UNKNOWN
  • Eswatini Nazarene Health Institutions

    lead OTHER

Principal Investigators

  • Phathizwe M Mantshana, BSc · Eswatini Nazarene Health Institution

  • Sarah H Perry, Ass professor · Baylor College of Medicine

  • Debrah Vambe, MD · Baylor College of Medicine

  • Mkunde S Chachage, PHD · University of Dar es Salaam-Mbeya

  • Clement Gascua AduGyamfi, G AduGyamfi,, PHD · Baylor College of Medicine

  • Alfred Balasa,, Associate Professor · Texas Children's Hospital Austin Baylor College of Medicine

  • ANDREW R DINARDO, associate professor · Baylor College of Medicine

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Eswatini

Study Locations

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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 NCT07165639 on ClinicalTrials.gov