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
  Purpose

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 Intervention
Uro-genital Schistosomiasis
Other: praziquantel

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Clinical and laboratory indicators of urogenital schistosomiasis [ Time Frame: 31. December 2014 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 6500
Study Start Date: April 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Girls ages 10-12 Other: praziquantel
One day, 40mg/kg standard mass rx as recommended by WHO and local authorities
Young adult women

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders 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

Criteria

Inclusion Criteria:

  • Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

  • Boys
  • Pregnancy
  • Allergic to praziquantel
  • Severe disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154907

Locations
South Africa
University of KwaZulu Natal
Durban, KwaZulu Natal, South Africa, 4000
Sponsors and Collaborators
Oslo University Hospital
University of KwaZulu
University of Agder
Sorlandet Hospital HF
University of Copenhagen
Leiden University Medical Center
Universiteit Antwerpen
Investigators
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

No publications provided

Responsible Party: Eyrun Floerecke Kjetland, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01154907     History of Changes
Other Study ID Numbers: VIBE-FGS
Study First Received: June 30, 2010
Last Updated: March 20, 2012
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by Oslo University Hospital:
Uro-genital schistosomiasis
Female
South Africa
Rural
Sexually transmitted diseases

Additional relevant MeSH terms:
Schistosomiasis
Schistosomiasis haematobia
Trematode Infections
Helminthiasis
Parasitic Diseases
Urinary Tract Infections
Infection
Urologic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014