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

NCT01154907 | Unknown DMC

• 1 other identifier: VIBE-FGS
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Uro-genital Schistosomiasis

Keywords

Uro-genital schistosomiasis; Female; South Africa; Rural; Sexually transmitted diseases

Outcome Measures

Primary Outcomes (1)

• HIV prevalence after anti-schistosomal treatment in adolescents

  HIV prevalence

  31. December 2021

Secondary Outcomes (2)

• FGS prevalence and severity after anti-schistosomal treatment in adolescents

  31. December 2021

• Clinical and laboratory indicators of urogenital schistosomiasis

  31. December 2018

Other Outcomes (1)

• Pocket Atlas of Female Genital Schistosomiasis

  31. December 2015

Study Arms (2)

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

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

Interventions

Praziquantel DRUG

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

Also known as: Biltricide

Girls ages 10-12; Young adult women

Eligibility Criteria

• Age: 10 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Females in Schistosoma haematobium endemic areas

You may not qualify if:

• Boys
• Pregnancy
• Allergic to praziquantel
• Severe disease

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of KwaZulu: collaborator
• University of Agder: collaborator
• Sorlandet Hospital HF: collaborator
• University of Copenhagen: collaborator
• Leiden University Medical Center: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

University of KwaZulu Natal

Durban, KwaZulu-Natal, 4000, South Africa

RECRUITING

Related Publications (16)

• 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.

  PMID: 27139497 BACKGROUND

• 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.

  PMID: 27658198 BACKGROUND

• 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.

  PMID: 27168759 RESULT

• 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.

  PMID: 27073857 RESULT

• 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.

  PMID: 25918212 RESULT

• 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.

  PMID: 25768005 RESULT

• 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.

  PMID: 25630808 RESULT

• 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.

  PMID: 25623258 RESULT

• 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.

  PMID: 25412334 RESULT

• 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.

  PMID: 25281761 RESULT

• 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.

  PMID: 25179171 RESULT

• 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.

  PMID: 24896815 RESULT

• 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.

  PMID: 24470560 RESULT

• 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.

  PMID: 23556009 RESULT

• 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.

  PMID: 27854250 RESULT

• 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.

  PMID: 29801483 DERIVED

Related Links

• Project website
• WHO pocket atlas for Female Genital Schistosomiasis

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, stool, blood, in the adults also vaginal lavage and Pap smears

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyrun Floereke Kjetland, MD, PhD

CONTACT

+47 97008579; e.f.kjetland@medidin.uio.no

Myra Taylor, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 2021-December 2022
• Access Criteria: From endemic country

Locations

ZA (1)