Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa (VIBE-FGS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of KwaZulu
University of Agder
Sorlandet Hospital HF
University of Copenhagen
Leiden University Medical Center
Universiteit Antwerpen
Information provided by (Responsible Party):
Eyrun Floerecke Kjetland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01154907
First received: June 30, 2010
Last updated: March 20, 2012
Last verified: March 2012

June 30, 2010
March 20, 2012
April 2010
December 2014   (final data collection date for primary outcome measure)
Clinical and laboratory indicators of urogenital schistosomiasis [ Time Frame: 31. December 2014 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154907 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa
Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa

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.

Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Urine, stool, blood, in the adults also vaginal lavage and Pap smears

Probability Sample

A random sample of school girls in Ugu district, KwaZulu Natal, South Africa

Uro-genital Schistosomiasis
Other: praziquantel
One day, 40mg/kg standard mass rx as recommended by WHO and local authorities
  • Girls ages 10-12
    Intervention: Other: praziquantel
  • Young adult women
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
6500
December 2018
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

  • Boys
  • Pregnancy
  • Allergic to praziquantel
  • Severe disease
Female
10 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01154907
VIBE-FGS
Yes
Eyrun Floerecke Kjetland, Oslo University Hospital
Oslo University Hospital
  • University of KwaZulu
  • University of Agder
  • Sorlandet Hospital HF
  • University of Copenhagen
  • Leiden University Medical Center
  • Universiteit Antwerpen
Principal Investigator: Eyrun F Kjetland, MD, PhD Oslo University Hospital, University of KwaZulu-Natal (UKZN)
Principal Investigator: Myra Taylor, PhD UKZN/ Child Development Research Unit (CDRU)
Principal Investigator: Jane Kvalsvig, PhD UKZN/ CDRU
Principal Investigator: Svein G Gundersen, MD, PhD Agder University Hospital / Sorlandet Hospital
Oslo University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP