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

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

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

Conditions
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Uro-genital Schistosomiasis

Intervention / Treatment
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* Drug: Praziquantel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females in Schistosoma haematobium endemic areas Exclusion Criteria: Boys Pregnancy Allergic to praziquantel Severe disease

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Girls ages 10-12<br>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 | Drug: Praziquantel<br>* One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities<br>* Other names: Biltricide;|
| Young adult women<br>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 | Drug: Praziquantel<br>* One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities<br>* Other names: Biltricide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV prevalence after anti-schistosomal treatment in adolescents | HIV prevalence | 31. December 2021 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uro-genital schistosomiasis, Female, South Africa, Rural, Sexually transmitted diseases