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

• Conditions: Uro-genital Schistosomiasis
• Interventions: Drug: Praziquantel

• Registration Number: NCT01154907
• Lead Sponsor: Oslo University Hospital

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19
• Primary Completion: 2018-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 6500

Inclusion Criteria

• Females in Schistosoma haematobium endemic areas

Exclusion Criteria

• Boys
• Pregnancy
• Allergic to praziquantel
• Severe disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Girls ages 10-12	Praziquantel	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
Young adult women	Praziquantel	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

Primary Outcome Measures

Name	Time	Method
HIV prevalence after anti-schistosomal treatment in adolescents	31. December 2021	HIV prevalence

Secondary Outcome Measures

Name	Time	Method
Clinical and laboratory indicators of urogenital schistosomiasis	31. December 2018	Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA)
FGS prevalence and severity after anti-schistosomal treatment in adolescents	31. December 2021	Clinical disease

Trial Locations

Locations (1)

University of KwaZulu Natal; 🇿🇦 Durban, KwaZulu Natal, South Africa