Clinical trial NCT01192282: Typing of Human Papilloma Virus (HPV) From Female Genital Warts
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Warts
Human Papilloma Virus
Keywords: Female Genital Warts
HPV Typing
HIV Status
Treatment Modalities and Recurrence
Socio-economic Burdens
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-09-01
Enrollment: 156
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All female patients with Genital Warts presenting to Groote Schuur Hospital, Cape Town

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.

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

Primary outcomes:
measure: HPV DNA and HIV Status
timeFrame: 18 Months
measure: HPV DNA and Pap Smear Results
timeFrame: 18 Months
measure: Number of HPV Genotypes Isolated by HIV Status
timeFrame: Up to 18 months
measure: Commonest HPV Genotypes Isolated by HIV Status
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Shahila Tayib, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Lynette Denny
role: PRINCIPAL_INVESTIGATOR
References: