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

NCT01192282 | Completed Results

• 1 other identifier: 131/2010
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Warts; Human Papilloma Virus

Keywords

Female Genital Warts; HPV Typing; HIV Status; Treatment Modalities and Recurrence; Socio-economic Burdens

Outcome Measures

Primary Outcomes (4)

• HPV DNA and HIV Status

  HPV DNA Positivity and HIV Status

  18 Months

• HPV DNA and Pap Smear Results

  Relationship between HPV DNA Positivity and Pap Smear Results

  18 Months

• Number of HPV Genotypes Isolated by HIV Status

  Number of HPV Genotypes isolated according to HIV Status

  Up to 18 months

• Commonest HPV Genotypes Isolated by HIV Status

  10 commonest types of HPV isolated according to HIV status

  18 months

Study Arms (1)

Genital Warts

All female patients with Genital Warts presenting to Groote Schuur Hospital

Procedure: Medical / Surgical Treatment

Interventions

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.

Genital Warts

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All female patients with Genital Warts presenting to Groote Schuur Hospital, Cape Town

You may qualify if:

• All female patients with genital warts

You may not qualify if:

• Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate

Sponsors & Collaborators

• University of Cape Town: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Condylomata Acuminata; Recurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Thirty (19.2%) specimens had to be rejected due to contamination that occurred during the analysis process. During the HPV DNA analysis, there were protocols for different aspect of controls during the analysis which needed to be negative.

Results Point of Contact

• Title: Dr Shahila Tayib
• Organization: Groote Schurr Hospital / University of Cape Town

syarq@yahoo.com

0060195773376

Study Officials

• Shahila Tayib, MBChB

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Lynette Denny

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2012
• Last Updated: January 24, 2013
• Results First Posted: January 15, 2013

Record last verified: 2013-01

Locations

ZA (1)