The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania (CYSTINET_Tz)

The Burden of (Neuro)Cysticercosis Among People Living With HIV Compared With HIV-negative Individuals in the Rural Southern Highlands in Tanzania

This study aims to compare the burden of neurocysticercosis among people living with HIV to people not infected with HIV.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Neurocysticercosis
• Intervention / Treatment: Diagnostic test: Diagnosis of (Neuro)cysticercosis

Detailed Description

People living with HIV and matched HIV negative controls will be tested serologically for cysticercosis, examined neurologically and will undergo CT scanning to determine the prevalence and presentation of NCC.

Furthermore, the immune system response in HIV patients with Taenia solium neurocysticercosis will be assessed.

• Study Type: Observational
• Enrollment (Actual): 2584

Contacts and Locations

• Study Contact: Name: Bernard J Ngowi, MD, PhD; Phone Number: +255 7639 18181; Email: b_ngowi@yahoo.co.uk
• Study Contact Backup: Name: Andrea S Winkler, MD, PhD; Phone Number: 9210 +49 89 4140; Email: andrea.winkler@tum.de

Study Locations

• Tanzania
  • Dar Es Salaam, Tanzania
    • National Institute of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1000 patients from HIV clinics will be recruited at the study sites in Mbeya and Iringa region. For each HIV-positive patient an HIV-negative control matched by age, sex and location will be included.

Description

Inclusion Criteria:

• Patients who consent to participate in the study and testing.
• Patients of age 14 years and above
• Patient living inside the study catchment area
• HIV-positive patients
• Patient suspected of taeniasis or cysticercosis/neurocysticercosis

Exclusion Criteria:

• Patients with opportunistic infections.
• Study participants taking anthelminthic drugs PZQ and ALB or have received them within the previous 12 months.
• Pregnant women
• Patients that are seriously ill.
• Patients with epilepsy and other mental disorders that impair thoughts and emotions such as psychosis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People living with HIV; People living with HIV (ART naive or on ART)	Diagnostic test: Diagnosis of (Neuro)cysticercosis; Serological tests for cysticercosis; Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis; Stool testing for T. solium
People not infected with HIV; HIV-negative people. Each participant is matched for age, sex and location to a study participant living with HIV	Diagnostic test: Diagnosis of (Neuro)cysticercosis; Serological tests for cysticercosis; Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis; Stool testing for T. solium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of cysticercosis	Prevalence of cysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common	Single assessment at inclusion into study (serological testing)
Prevalence of neurocysticercosis	Prevalence of neurocysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common	Single assessment through cerebral CT scan at inclusion into study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Th1 cytokines among neurocysticercosis patients	To compare the specific peripheral immune response against T. solium neurocysticercosis between symptomatic and asymptomatic patients measured by concentration of Th1 cytokines.	One time assessment through immunological testing at inclusion into study

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: National Institute for Medical Research, Tanzania; Muhimbili University of Health and Allied Sciences; Kilimanjaro Clinical Research Institute
• Investigators: Principal Investigator: Bernard J Ngowi, MD, PhD, National Institute for Medical Research

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Cysticercosis; Taeniasis; Neurocysticercosis
• Other Study ID Numbers: CYSTINET-Africa Tz II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No