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

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ClinicalTrials.gov Identifier: NCT01154907
Recruitment Status : Recruiting
First Posted : July 1, 2010
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Uro-genital Schistosomiasis Drug: Praziquantel

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

Study Design

Study Type : Observational
Estimated Enrollment : 6500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa
Study Start Date : April 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Drug: Praziquantel
One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities
Other Name: Biltricide
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

Drug: Praziquantel
One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities
Other Name: Biltricide

Outcome Measures

Primary Outcome Measures :
  1. HIV prevalence after anti-schistosomal treatment in adolescents [ Time Frame: 31. December 2021 ]
    HIV prevalence

Secondary Outcome Measures :
  1. FGS prevalence and severity after anti-schistosomal treatment in adolescents [ Time Frame: 31. December 2021 ]
    Clinical disease

  2. Clinical and laboratory indicators of urogenital schistosomiasis [ Time Frame: 31. December 2018 ]
    Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA)

Other Outcome Measures:
  1. Pocket Atlas of Female Genital Schistosomiasis [ Time Frame: 31. December 2015 ]
    Published by WHO in English, French and Portuguese

Biospecimen Retention:   Samples Without DNA
Urine, stool, blood, in the adults also vaginal lavage and Pap smears

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A random sample of school girls in Ugu district, KwaZulu Natal, South Africa

Inclusion Criteria:

  • Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

  • Boys
  • Pregnancy
  • Allergic to praziquantel
  • Severe disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154907

Contact: Eyrun Floereke Kjetland, MD, PhD +47 97008579 e.f.kjetland@medidin.uio.no
Contact: Myra Taylor, MD, PhD

South Africa
University of KwaZulu Natal Recruiting
Durban, KwaZulu Natal, South Africa, 4000
Contact: Eyrun F. Kjetland, MD, PhD    +27 76 4920800    e.f.kjetland@medisin.uio.no   
Contact: Myra Taylor, MD, PhD    +27 31 2604499    taylor@ukzn.ac.za   
Sub-Investigator: Elisabeth Kleppa, MD         
Sponsors and Collaborators
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
More Information

Additional Information:

Responsible Party: Eyrun Floerecke Kjetland, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01154907     History of Changes
Other Study ID Numbers: VIBE-FGS
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Still collecting and publishing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: December 2021-December 2022
Access Criteria: From endemic country

Keywords provided by Eyrun Floerecke Kjetland, Oslo University Hospital:
Uro-genital schistosomiasis
South Africa
Sexually transmitted diseases

Additional relevant MeSH terms:
Schistosomiasis haematobia
Trematode Infections
Parasitic Diseases
Urinary Tract Infections
Urologic Diseases
Antiparasitic Agents
Anti-Infective Agents