Typing of Human Papilloma Virus (HPV) From Female Genital Warts
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01192282 |
Recruitment Status
:
Completed
First Posted
: September 1, 2010
Results First Posted
: January 15, 2013
Last Update Posted
: January 24, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Genital Warts Human Papilloma Virus | Procedure: Medical / Surgical Treatment |
Genital Human Papillomavirus (HPV) infection is the most common sexually transmitted viral disease in the world.1,2 HPV infection on genital epithelia is associated with a range of disease spectra, from visible lesions such as genital warts, cervical, vaginal, vulval, anal and penile intraepithelial cancers and their precursors, or they may co- exist in the latent form in apparently normal epithelium.3,4 It is established that genital warts are associated with low-risk HPV genotypes, with the causative agents being HPV-6 and HPV-11 in almost 100% of cases.5 However, recent studies have shown that 20 to 50% of lesions also contain co-infection with high-risk HPV types.6,7
Although genital warts are not life-threatening, they cause significant psychosocial morbidities resulting in low self-esteem, negative self-perception, embarrassment and anxiety.8,9 Genital warts also represent not only a health problem for the individual, but also an economic burden for society as they carry a high and immediate financial burden and health care cost due to their generally recalcitrant response to conventional therapies.9 With this in mind, immunization with HPV 6/11/16/18 recombinant vaccine holds promise for reducing overall burden on clinical HPV-related diseases.
Genital warts are a common cause for referral to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town which is a tertiary hospital serving the wider Cape Town area and the Western Cape Province. With an increasing number of cases seen requiring multiple clinical visits for treatment and a high number of recurrent and persistent cases, we undertook this study to examine the nature of the disease from a clinical point of view, response to various therapies, the impact of HIV and the types of HPV causing or associated with genital warts in women referred to our clinic.
Study Type : | Observational |
Actual Enrollment : | 156 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Clinico-Pathological HPV DNA Typing Study of Women With Genital Warts Presenting to Groote Schuur Hospital Over a One Year Period, Evaluated by HIV Status, Psychological Impact and Costs to the Health Care System |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | August 2012 |
Group/Cohort | Intervention/treatment |
---|---|
Genital Warts
All female patients with Genital Warts presenting to Groote Schuur Hospital
|
Procedure: Medical / Surgical Treatment
All participants received treatment based on the morphology and distributions of lesions. For the treatment with Trichloroacetic Acid (TCA), patients were advised to attend the clinic weekly until no visible lesions seen. For electrosurgery or laser, patients were given a date for admission a day prior to surgery. Post-operatively, she remained in the ward for at least five days.
|
- HPV DNA and HIV Status [ Time Frame: 18 Months ]HPV DNA Positivity and HIV Status
- HPV DNA and Pap Smear Results [ Time Frame: 18 Months ]Relationship between HPV DNA Positivity and Pap Smear Results
- Number of HPV Genotypes Isolated by HIV Status [ Time Frame: Up to 18 months ]Number of HPV Genotypes isolated according to HIV Status
- Commonest HPV Genotypes Isolated by HIV Status [ Time Frame: 18 months ]10 commonest types of HPV isolated according to HIV status

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: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- All female patients with genital warts
Exclusion Criteria:
- Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate

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): NCT01192282
South Africa | |
Groote Schuur Hospital | |
Cape Town, Western Cape, South Africa, 7925 |
Principal Investigator: | Shahila Tayib, MBChB | University of Cape Town | |
Principal Investigator: | Lynette Denny | University of Cape Town |
Responsible Party: | Shahila Tayib, Dr, University of Cape Town |
ClinicalTrials.gov Identifier: | NCT01192282 History of Changes |
Other Study ID Numbers: |
131/2010 |
First Posted: | September 1, 2010 Key Record Dates |
Results First Posted: | January 15, 2013 |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Keywords provided by Shahila Tayib, University of Cape Town:
Female Genital Warts HPV Typing HIV Status Treatment Modalities and Recurrence Socio-economic Burdens |
Additional relevant MeSH terms:
Papilloma Warts Condylomata Acuminata Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Papillomavirus Infections |
DNA Virus Infections Virus Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |