Uro-genital Schistosomiasis Clinical Trial
— VIBE-FGSOfficial title:
Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa
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.
| Status | Recruiting |
| Enrollment | 6500 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 10 Years to 23 Years |
| Eligibility |
Inclusion Criteria: - Females in Schistosoma haematobium endemic areas Exclusion Criteria: - Boys - Pregnancy - Allergic to praziquantel - Severe disease |
| Country | Name | City | State |
|---|---|---|---|
| South Africa | University of KwaZulu Natal | Durban | KwaZulu Natal |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital | Leiden University Medical Center, Sorlandet Hospital HF, Universiteit Antwerpen, University of Agder, University of Copenhagen, University of KwaZulu |
South Africa,
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. — View Citation
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. — View Citation
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 f — View Citation
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):e210 — View Citation
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 Neg — View Citation
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. Ep — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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 a — View Citation
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, Madagasca — View Citation
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 urogeni — View Citation
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. 20 — View Citation
* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Pocket Atlas of Female Genital Schistosomiasis | Published by WHO in English, French and Portuguese | 31. December 2015 | |
| Primary | HIV prevalence after anti-schistosomal treatment in adolescents | HIV prevalence | 31. December 2021 | |
| Secondary | FGS prevalence and severity after anti-schistosomal treatment in adolescents | Clinical disease | 31. December 2021 | |
| Secondary | Clinical and laboratory indicators of urogenital schistosomiasis | Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA) | 31. December 2018 |