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

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.

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Key information

Conditions

Genital Warts Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Human Papilloma Virus Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Sex eligibility

Female

Study type

Observational

Primary location

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical / Surgical Treatment

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Sep 1, 2010
Registry last updated: Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed