Uro-genital SchistosomiasisVIBE-FGSNCT01154907
Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa
An observational study of Uro-genital Schistosomiasis, run by Oslo University Hospital at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 23 years, women only
- Conditions the study is for
- Uro-genital Schistosomiasis
- What is being tested?
- Praziquantel
- How many people
- 6,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2010to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: A random sample of school girls in Ugu district, KwaZulu Natal, South Africa
Who may be able to join
- Females in Schistosoma haematobium endemic areas
Who cannot join
- Boys
- Pregnancy
- Allergic to praziquantel
- Severe disease
Trial locations and contacts
1 site in 1 country.
Myra Taylor, MD, PhD contact
South Africa1 site, 1 recruiting
- Recruiting
University of KwaZulu Natal
Durban, KwaZulu-Natal, 4000
Eyrun F. Kjetland, MD, PhD, +27 76 4920800, e.f.kjetland@medisin.uio.no
Myra Taylor, MD, PhD, +27 31 2604499, taylor@ukzn.ac.za
About this study
Official 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.
Read the detailed description
Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures
- Conditions
- Uro-genital Schistosomiasis
- Being tested
- Praziquantel
- Keywords
- Uro-genital schistosomiasis, Female, South Africa, Rural, Sexually transmitted diseases
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraziquantelDrug
Also called Biltricide
One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV prevalence after anti-schistosomal treatment in adolescents
HIV prevalence
Measured: 31. December 2021
Secondary outcomes (2)
FGS prevalence and severity after anti-schistosomal treatment in adolescents
Clinical disease
Measured: 31. December 2021
Clinical and laboratory indicators of urogenital schistosomiasis
Polymerase chain reaction (PCR) of vaginal lavage, Cytology, Circulation Anodic Antigen (CAA)
Measured: 31. December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Uro-genital SchistosomiasisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of KwaZulu, University of Agder, Sorlandet Hospital HF, University of Copenhagen, Leiden University Medical Center, Universiteit Antwerpen
- Responsible party
- Principal investigator, Eyrun Floerecke Kjetland, Oslo University Hospital
- Investigators
- Eyrun F Kjetland, MD, PhD, Principal investigator, Oslo University Hospital, University of KwaZulu-Natal (UKZN)Myra Taylor, PhD, Principal investigator, UKZN/ Child Development Research Unit (CDRU)Jane Kvalsvig, PhD, Principal investigator, UKZN/ CDRUSvein G Gundersen, MD, PhD, Principal investigator, Agder University Hospital / Sorlandet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154907
- Sponsor's protocol ID
- VIBE-FGS
- Acronym
- VIBE-FGS
- Status last verified
- Sep 2017
- First submitted
- 30 Jun 2010
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Still collecting and publishing
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.
PubMed 27139497Bustinduy 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.
PubMed 27658198Pillay 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.
PubMed 27168759Holmen 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.
PubMed 27073857Holmen 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.
PubMed 25918212Kleppa 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.
PubMed 25768005Holmen 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.
PubMed 25630808Kildemoes 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.
PubMed 25623258Norseth 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.
PubMed 25412334Kleppa 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.
PubMed 25281761Kjetland 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.
PubMed 25179171Kleppa 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.
PubMed 24896815Pillay 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.
PubMed 24470560Hegertun 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.
PubMed 23556009Galappaththi-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.
PubMed 27854250
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa
- ClinicalTrials.gov ID
- NCT01154907
- Acronym / sponsor ID
- VIBE-FGS / VIBE-FGS
- Conditions
- Uro-genital Schistosomiasis
- Keywords
- Uro-genital schistosomiasis, Female, South Africa, Rural, Sexually transmitted diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of KwaZulu, University of Agder, Sorlandet Hospital HF, University of Copenhagen, Leiden University Medical Center, Universiteit Antwerpen
- Study start
- Apr 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Girls ages 10-12 | – | Drug: PraziquantelIn 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 |
| Young adult women | – | Drug: PraziquantelIn 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 |
Who may qualify
- Ages
- 10 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A random sample of school girls in Ugu district, KwaZulu Natal, South Africa
Key inclusion criteria (1 listed)
- Females in Schistosoma haematobium endemic areas
Key exclusion criteria (4 listed)
- Boys
- Pregnancy
- Allergic to praziquantel
- Severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PraziquantelAlso: BiltricideOne day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities | Drug | Girls ages 10-12, Young adult women |
Primary outcome
HIV prevalence after anti-schistosomal treatment in adolescents
Time frame: 31. December 2021
HIV prevalence
2 secondary outcomes
FGS prevalence and severity after anti-schistosomal treatment in adolescents
Time frame: 31. December 2021
Clinical and laboratory indicators of urogenital schistosomiasis
Time frame: 31. December 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Background: PubMed 27139497Baan 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.
- Background: PubMed 27658198Bustinduy 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.
- Results publication: PubMed 27168759Pillay 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.
- Results publication: PubMed 27073857Holmen 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.
- Results publication: PubMed 25918212Holmen 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.
- Results publication: PubMed 25768005Kleppa 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.
- Results publication: PubMed 25630808Holmen 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.
- Results publication: PubMed 25623258Kildemoes 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.
- Results publication: PubMed 25412334Norseth 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.
- Results publication: PubMed 25281761Kleppa 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.
- Results publication: PubMed 25179171Kjetland 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.
- Results publication: PubMed 24896815Kleppa 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.
- Project websiteLink provided by the sponsor.
- WHO pocket atlas for Female Genital SchistosomiasisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Still collecting and publishing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myra Taylor, MD, PhD contact
Eyrun F Kjetland, MD, PhD principal investigator
Oslo University Hospital, University of KwaZulu-Natal (UKZN)
Myra Taylor, PhD principal investigator
UKZN/ Child Development Research Unit (CDRU)
Jane Kvalsvig, PhD principal investigator
UKZN/ CDRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uro-genital Schistosomiasis, run by Oslo University Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyrun Floereke Kjetland, MD, PhD (+47 97008579, e.f.kjetland@medidin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV prevalence after anti-schistosomal treatment in adolescents (time frame: 31. December 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154907, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.