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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


N/A
N/A
N/A
Not Enrolling
Female
Genital Warts, Human Papilloma Virus

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

HPV DNA and HIV Status

Outcome Description:

HPV DNA Positivity and HIV Status

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

Shahila Tayib, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cape Town

Authority:

South Africa: Human Research Ethics Committee

Study ID:

131/2010

NCT ID:

NCT01192282

Start Date:

April 2010

Completion Date:

August 2012

Related Keywords:

  • Genital Warts
  • Human Papilloma Virus
  • Female Genital Warts
  • HPV Typing
  • HIV Status
  • Treatment Modalities and Recurrence
  • Socio-economic Burdens
  • Condylomata Acuminata
  • Papilloma
  • Warts

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