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

Sponsor

Oslo University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01154907

Collaborator

University of KwaZulu (Other), University of Agder (Other), Sorlandet Hospital HF (Other), University of Copenhagen (Other), Leiden University Medical Center (Other), Universiteit Antwerpen (Other)

6,500

Enrollment

Location

140

Duration (Months)

46.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uro-genital Schistosomiasis	Drug: Praziquantel

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 Design

Study Type:

Observational

Anticipated Enrollment :

6500 participants

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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Girls ages 10-12 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 One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities Other Names: Biltricide
Young adult women 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 One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities Other Names: Biltricide

Arm

Intervention/Treatment

Girls ages 10-12

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

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

Other Names:

Biltricide

Young adult women

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

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

Other Names:

Biltricide

Outcome Measures

Primary Outcome Measures

HIV prevalence after anti-schistosomal treatment in adolescents [31. December 2021]
HIV prevalence

Secondary Outcome Measures

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

Other Outcome Measures

Pocket Atlas of Female Genital Schistosomiasis [31. December 2015]
Published by WHO in English, French and Portuguese

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 23 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

Boys
Pregnancy
Allergic to praziquantel
Severe disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of KwaZulu Natal	Durban	KwaZulu Natal	South Africa	4000

Sponsors and Collaborators

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

Investigators

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