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NCT07165639
The Eswatini Study on Neurocognitive Performance in Adolescents Living With HIV
trial in HIV (Human Immunodeficiency Virus) in 80 participants. Not yet recruiting.
31 May 2026
Quick facts
| Lead sponsor | Eswatini Nazarene Health Institutions |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 30 November 2025 |
| Primary completion | 31 May 2026 |
| Estimated completion | 31 May 2026 |
| Sites | 1 location across Eswatini |
Conditions studied
- HIV (Human Immunodeficiency Virus) — all drugs for HIV (Human Immunodeficiency Virus) →
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 Eswatini Nazarene Health Institutions trials
Trials by the same sponsor.
- NCT07101458 — The Eswatini PRISM Study on Adolescents Living With HIV · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07165639 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eswatini Nazarene Health Institutions
- Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07165639.
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