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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01154907
Acronym
VIBE-FGS
Enrollment
6500
Registered
2010-07-01
Start date
2010-04-30
Completion date
2021-12-31
Last updated
2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uro-genital Schistosomiasis

Keywords

Uro-genital schistosomiasis, Female, South Africa, Rural, Sexually transmitted diseases

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

Interventions

DRUGPraziquantel

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

Sponsors

University of KwaZulu
CollaboratorOTHER
University of Agder
CollaboratorOTHER
Sorlandet Hospital HF
CollaboratorOTHER_GOV
University of Copenhagen
CollaboratorOTHER
Leiden University Medical Center
CollaboratorOTHER
Universiteit Antwerpen
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 23 Years
Healthy volunteers
No

Inclusion criteria

* Females in Schistosoma haematobium endemic areas

Exclusion criteria

* Boys * Pregnancy * Allergic to praziquantel * Severe disease

Design outcomes

Primary

MeasureTime frameDescription
HIV prevalence after anti-schistosomal treatment in adolescents31. December 2021HIV prevalence

Secondary

MeasureTime frameDescription
FGS prevalence and severity after anti-schistosomal treatment in adolescents31. December 2021Clinical disease
Clinical and laboratory indicators of urogenital schistosomiasis31. December 2018Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA)

Other

MeasureTime frameDescription
Pocket Atlas of Female Genital Schistosomiasis31. December 2015Published by WHO in English, French and Portuguese

Countries

South Africa

Contacts

Primary ContactEyrun Floereke Kjetland, MD, PhD
e.f.kjetland@medidin.uio.no+47 97008579
Backup ContactMyra Taylor, MD, PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026