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

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.

Study Overview

• Status: Unknown
• Conditions: Uro-genital Schistosomiasis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 6500

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 23 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

A random sample of school girls in Ugu district, KwaZulu Natal, South Africa

Description

Inclusion Criteria:

• Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

• Boys
• Pregnancy
• Allergic to praziquantel
• Severe disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket Atlas of Female Genital Schistosomiasis	Published by WHO in English, French and Portuguese	31. December 2015

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Copenhagen; Sorlandet Hospital HF; University of Agder; Leiden University Medical Center; Universiteit Antwerpen; University of KwaZulu
• 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

Publications and helpful links

General Publications

• 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. No abstract available.
• 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, Lillebo 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):80-86. doi: 10.4269/ajtmh.15-0071. Epub 2015 Apr 27.
• Kleppa E, Klinge KF, Galaphaththi-Arachchige HN, Holmen SD, Lillebo 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, Lillebo 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, Lillebo 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, Lillebo 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. No abstract available.
• Kleppa E, Ramsuran V, Zulu S, Karlsen GH, Bere A, Passmore JA, Ndhlovu P, Lillebo 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):1135. doi: 10.3390/ijerph13111135.
• Lothe A, Zulu N, Oyhus AO, Kjetland EF, Taylor M. Treating schistosomiasis among South African high school pupils in an endemic area, a qualitative study. BMC Infect Dis. 2018 May 25;18(1):239. doi: 10.1186/s12879-018-3102-0.

Helpful Links

• Project website
• WHO pocket atlas for Female Genital Schistosomiasis

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (ESTIMATE): July 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: South Africa; Female; Rural; Sexually transmitted diseases; Uro-genital schistosomiasis
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Vector Borne Diseases; Parasitic Diseases; Helminthiasis; Urinary Tract Infections; Trematode Infections; Schistosomiasis; Schistosomiasis haematobia; Anti-Infective Agents; Antiparasitic Agents; Anthelmintics; Praziquantel
• Other Study ID Numbers: VIBE-FGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Still collecting and publishing
• IPD Sharing Time Frame: December 2021-December 2022
• IPD Sharing Access Criteria: From endemic country
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF