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

This study is currently recruiting participants.
Verified September 2017 by Eyrun Floerecke Kjetland, Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154907
First Posted: July 1, 2010
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of KwaZulu
University of Agder
Sorlandet Hospital HF
University of Copenhagen
Leiden University Medical Center
Universiteit Antwerpen
Information provided by (Responsible Party):
Eyrun Floerecke Kjetland, Oslo University Hospital
  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 Drug: 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

Resource links provided by NLM:


Further study details as provided by Eyrun Floerecke Kjetland, Oslo University Hospital:

Primary Outcome Measures:
  • HIV prevalence after anti-schistosomal treatment in adolescents [ Time Frame: 31. December 2021 ]
    HIV prevalence


Secondary Outcome Measures:
  • FGS prevalence and severity after anti-schistosomal treatment in adolescents [ Time Frame: 31. December 2021 ]
    Clinical disease

  • Clinical and laboratory indicators of urogenital schistosomiasis [ Time Frame: 31. December 2018 ]
    Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA)


Other Outcome Measures:
  • Pocket Atlas of Female Genital Schistosomiasis [ Time Frame: 31. December 2015 ]
    Published by WHO in English, French and Portuguese


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 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Biltricide

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A random sample of school girls in Ugu district, KwaZulu Natal, South Africa
Criteria

Inclusion Criteria:

  • Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

  • Boys
  • Pregnancy
  • Allergic to praziquantel
  • Severe disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154907


Contacts
Contact: Eyrun Floereke Kjetland, MD, PhD +47 97008579 e.f.kjetland@medidin.uio.no
Contact: Myra Taylor, MD, PhD

Locations
South Africa
University of KwaZulu Natal Recruiting
Durban, KwaZulu Natal, South Africa, 4000
Contact: Eyrun F. Kjetland, MD, PhD    +27 76 4920800    e.f.kjetland@medisin.uio.no   
Contact: Myra Taylor, MD, PhD    +27 31 2604499    taylor@ukzn.ac.za   
Sub-Investigator: Elisabeth Kleppa, MD         
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
  More Information

Additional Information:
Publications:
Pillay P, van Lieshout L, Taylor M, Sebitloane M, Zulu SG, Kleppa E, Roald B, Kjetland EF. Cervical cytology as a diagnostic tool for female genital schistosomiasis: Correlation to cervical atypia and Schistosoma polymerase chain reaction. Cytojournal. 2016 Apr 20;13:10. doi: 10.4103/1742-6413.180784. eCollection 2016.
Holmen S, Galappaththi-Arachchige HN, Kleppa E, Pillay P, Naicker T, Taylor M, Onsrud M, Kjetland EF, Albregtsen F. Characteristics of Blood Vessels in Female Genital Schistosomiasis: Paving the Way for Objective Diagnostics at the Point of Care. PLoS Negl Trop Dis. 2016 Apr 13;10(4):e0004628. doi: 10.1371/journal.pntd.0004628. eCollection 2016 Apr.
Holmen SD, Kleppa E, Lillebø K, Pillay P, van Lieshout L, Taylor M, Albregtsen F, Vennervald BJ, Onsrud M, Kjetland EF. The first step toward diagnosing female genital schistosomiasis by computer image analysis. Am J Trop Med Hyg. 2015 Jul;93(1):80-6. doi: 10.4269/ajtmh.15-0071. Epub 2015 Apr 27.
Kleppa E, Klinge KF, Galaphaththi-Arachchige HN, Holmen SD, Lillebø K, Onsrud M, Gundersen SG, Taylor M, Ndhlovu P, Kjetland EF. Schistosoma haematobium infection and CD4+ T-cell levels: a cross-sectional study of young South African women. PLoS One. 2015 Mar 13;10(3):e0119326. doi: 10.1371/journal.pone.0119326. eCollection 2015.
Holmen SD, Kjetland EF, Taylor M, Kleppa E, Lillebø K, Gundersen SG, Onsrud M, Albregtsen F. Colourimetric image analysis as a diagnostic tool in female genital schistosomiasis. Med Eng Phys. 2015 Mar;37(3):309-14. doi: 10.1016/j.medengphy.2014.12.007. Epub 2015 Jan 24.
Kildemoes AO, Kjetland EF, Zulu SG, Taylor M, Vennervald BJ. Schistosoma haematobium infection and asymptomatic bacteriuria in young South African females. Acta Trop. 2015 Apr;144:19-23. doi: 10.1016/j.actatropica.2015.01.008. Epub 2015 Jan 24.
Norseth HM, Ndhlovu PD, Kleppa E, Randrianasolo BS, Jourdan PM, Roald B, Holmen SD, Gundersen SG, Bagratee J, Onsrud M, Kjetland EF. The colposcopic atlas of schistosomiasis in the lower female genital tract based on studies in Malawi, Zimbabwe, Madagascar and South Africa. PLoS Negl Trop Dis. 2014 Nov 20;8(11):e3229. doi: 10.1371/journal.pntd.0003229. eCollection 2014.
Kleppa E, Holmen SD, Lillebø K, Kjetland EF, Gundersen SG, Taylor M, Moodley P, Onsrud M. Cervical ectopy: associations with sexually transmitted infections and HIV. A cross-sectional study of high school students in rural South Africa. Sex Transm Infect. 2015 Mar;91(2):124-9. doi: 10.1136/sextrans-2014-051674. Epub 2014 Oct 3.
Kjetland EF, Norseth HM, Taylor M, Lillebø K, Kleppa E, Holmen SD, Andebirhan A, Yohannes TH, Gundersen SG, Vennervald BJ, Bagratee J, Onsrud M, Leutscher PD. Classification of the lesions observed in female genital schistosomiasis. Int J Gynaecol Obstet. 2014 Dec;127(3):227-8. doi: 10.1016/j.ijgo.2014.07.014. Epub 2014 Aug 13.
Kleppa E, Ramsuran V, Zulu S, Karlsen GH, Bere A, Passmore JA, Ndhlovu P, Lillebø K, Holmen SD, Onsrud M, Gundersen SG, Taylor M, Kjetland EF, Ndung'u T. Effect of female genital schistosomiasis and anti-schistosomal treatment on monocytes, CD4+ T-cells and CCR5 expression in the female genital tract. PLoS One. 2014 Jun 4;9(6):e98593. doi: 10.1371/journal.pone.0098593. eCollection 2014.
Pillay P, Taylor M, Zulu SG, Gundersen SG, Verweij JJ, Hoekstra P, Brienen EA, Kleppa E, Kjetland EF, van Lieshout L. Real-time polymerase chain reaction for detection of Schistosoma DNA in small-volume urine samples reflects focal distribution of urogenital Schistosomiasis in primary school girls in KwaZulu Natal, South Africa. Am J Trop Med Hyg. 2014 Mar;90(3):546-52. doi: 10.4269/ajtmh.13-0406. Epub 2014 Jan 27.
Hegertun IE, Sulheim Gundersen KM, Kleppa E, Zulu SG, Gundersen SG, Taylor M, Kvalsvig JD, Kjetland EF. S. haematobium as a common cause of genital morbidity in girls: a cross-sectional study of children in South Africa. PLoS Negl Trop Dis. 2013;7(3):e2104. doi: 10.1371/journal.pntd.0002104. Epub 2013 Mar 21.
Galappaththi-Arachchige HN, Amlie Hegertun IE, Holmen S, Qvigstad E, Kleppa E, Sebitloane M, Ndhlovu PD, Vennervald BJ, Gundersen SG, Taylor M, Kjetland EF. Association of Urogenital Symptoms with History of Water Contact in Young Women in Areas Endemic for S. haematobium. A Cross-Sectional Study in Rural South Africa. Int J Environ Res Public Health. 2016 Nov 14;13(11). pii: E1135.
Baan M, Galappaththi-Arachchige HN, Gagai S, Aurlund CG, Vennervald BJ, Taylor M, van Lieshout L, Kjetland EF. The Accuracy of Praziquantel Dose Poles for Mass Treatment of Schistosomiasis in School Girls in KwaZulu-Natal, South Africa. PLoS Negl Trop Dis. 2016 May 3;10(5):e0004623. doi: 10.1371/journal.pntd.0004623. eCollection 2016 May.
Bustinduy AL, Friedman JF, Kjetland EF, Ezeamama AE, Kabatereine NB, Stothard JR, King CH. Expanding Praziquantel (PZQ) Access beyond Mass Drug Administration Programs: Paving a Way Forward for a Pediatric PZQ Formulation for Schistosomiasis. PLoS Negl Trop Dis. 2016 Sep 22;10(9):e0004946. doi: 10.1371/journal.pntd.0004946. eCollection 2016 Sep.

Responsible Party: Eyrun Floerecke Kjetland, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01154907     History of Changes
Other Study ID Numbers: VIBE-FGS
First Submitted: June 30, 2010
First Posted: July 1, 2010
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Still collecting and publishing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: December 2021-December 2022
Access Criteria: From endemic country

Keywords provided by Eyrun Floerecke Kjetland, 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


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