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

This study is currently recruiting participants.
Verified September 2017 by Eyrun Floerecke Kjetland, Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154907
First Posted: July 1, 2010
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
June 30, 2010
July 1, 2010
September 19, 2017
April 2010
December 2018   (Final data collection date for primary outcome measure)
HIV prevalence after anti-schistosomal treatment in adolescents [ Time Frame: 31. December 2021 ]
HIV prevalence
Clinical and laboratory indicators of urogenital schistosomiasis [ Time Frame: 31. December 2014 ]
Complete list of historical versions of study NCT01154907 on ClinicalTrials.gov Archive Site
  • FGS prevalence and severity after anti-schistosomal treatment in adolescents [ Time Frame: 31. December 2021 ]
    Clinical disease
  • Clinical and laboratory indicators of urogenital schistosomiasis [ Time Frame: 31. December 2018 ]
    Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA)
Not Provided
Pocket Atlas of Female Genital Schistosomiasis [ Time Frame: 31. December 2015 ]
Published by WHO in English, French and Portuguese
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
Drug: Praziquantel
One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities
Other Name: Biltricide
  • Girls ages 10-12

    In 18 rural schools in Ugu District, South Africa. Undergoing mass-treatment provided by the Department of Health.

    Praziquantel was administered at 40mg/kg in annual mass-treatment

    Intervention: Drug: Praziquantel
  • Young adult women

    In rural schools in three districts, South Africa. Undergoing mass-treatment provided by the Departments of Health.

    Praziquantel was administered at 40mg/kg in annual mass-treatment

    Intervention: Drug: Praziquantel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6500
December 2021
December 2018   (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
Sexes Eligible for Study: Female
10 Years to 23 Years   (Child, Adult)
No
Contact: Eyrun Floereke Kjetland, MD, PhD +47 97008579 e.f.kjetland@medidin.uio.no
Contact: Myra Taylor, MD, PhD
South Africa
 
 
NCT01154907
VIBE-FGS
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Still collecting and publishing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: December 2021-December 2022
Access Criteria: From endemic country
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
September 2017