Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa (VIBE-FGS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| South Africa | |
| University of KwaZulu Natal | |
| Durban, KwaZulu Natal, South Africa, 4000 | |
| 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 May 19, 2013