Overview

This trial is active, not recruiting.

Condition uro-genital schistosomiasis
Treatment praziquantel
Sponsor Oslo University Hospital
Collaborator University of KwaZulu
Start date April 2010
End date December 2018
Trial size 6500 participants
Trial identifier NCT01154907, VIBE-FGS

Summary

Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that 200 million people world wide. Infection with Schistosoma haematobium may cause Female Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract, especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of young women in endemic poor tropical countries, deserving further attention. A cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were unchanged two years after praziquantel treatment in adult women whereas in those who had been treated with praziquantel in childhood the prevalence of genital lesions was significantly lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to those without. The proposed project aims at achieving a better understanding of how annual distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This information can be of use in current schistosomiasis control programs in the near term resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and genital lesions will lead to improved reproductive health among in women living in schistosomiasis endemic areas.

Project Goal: Contribute to a reduction of the global burden of female genital schistosomiasis (FGS) through improved knowledge about the prevention of gynecological lesions and through improved diagnosis of FGS.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
In 18 rural schools in Ugu District, South Africa. Undergoing mass-treatment provided by the Department of Health. Praziquatel was administered at 40mg/kg in annual mass-treatment
praziquantel Biltricide
One day, 40mg/kg standard mass rx as recommended by WHO and local authorities
In rural schools in three districts, South Africa. Undergoing mass-treatment provided by the Departments of Health. Praziquatel was administered at 40mg/kg in annual mass-treatment
praziquantel Biltricide
One day, 40mg/kg standard mass rx as recommended by WHO and local authorities

Primary Outcomes

Measure
HIV prevalence after anti-schistosomal treatment in adolescents
time frame: 31. December 2021

Secondary Outcomes

Measure
FGS prevalence and severity after anti-schistosomal treatment in adolescents
time frame: 31. December 2021
Clinical and laboratory indicators of urogenital schistosomiasis
time frame: 31. December 2018

Eligibility Criteria

Female participants from 10 years up to 20 years old.

Inclusion Criteria: - Females in Schistosoma haematobium endemic areas Exclusion Criteria: - Boys - Pregnancy - Allergic to praziquantel - Severe disease

Additional Information

Official title Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa
Principal investigator Eyrun F Kjetland, MD, PhD
Description Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.