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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2010

Last Updated Date

March 20, 2012

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01154907 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

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

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Uro-genital Schistosomiasis

Intervention ^ICMJE

Other: praziquantel

One day, 40mg/kg standard mass rx as recommended by WHO and local authorities

Study Group/Cohort (s)

Girls ages 10-12
Intervention: Other: praziquantel
Young adult women

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

6500

Estimated Completion Date

December 2018

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

Boys
Pregnancy
Allergic to praziquantel
Severe disease

Gender

Female

Ages

10 Years to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT Number ^ICMJE

NCT01154907

Other Study ID Numbers ^ICMJE

VIBE-FGS

Has Data Monitoring Committee

Yes

Responsible Party

Eyrun Floerecke Kjetland, Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

University of KwaZulu
University of Agder
Sorlandet Hospital HF
University of Copenhagen
Leiden University Medical Center
Universiteit Antwerpen

Investigators ^ICMJE

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

Information Provided By

Oslo University Hospital

Verification Date

March 2012

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

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