Typing of Human Papilloma Virus (HPV) From Female Genital Warts

NCT ID: NCT01192282

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-08-31

Brief Summary

This is a longitudinal observational study of women presenting to Groote Schuur Hospital with genital warts. The study will evaluate the socio-demographic characteristics of the women using a structured questionnaire. It will also document the site and extend of the genital warts and genotyping will be performed on the warts. HIV status will be determined with patient consent, treatment modalities will be documented as will the outcome of treatment over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed as will the costs of treating women with genital warts.

Detailed Description

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.

Conditions

Genital Warts; Human Papilloma Virus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Genital Warts

All female patients with Genital Warts presenting to Groote Schuur Hospital

Medical / Surgical Treatment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Shahila Tayib

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahila Tayib, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Lynette Denny

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Countries

South Africa

Other Identifiers

131/2010

Identifier Type: -

Identifier Source: org_study_id