Genital Warts, Human Papilloma Virus
Conditions
Keywords
Female Genital Warts, HPV Typing, HIV Status, Treatment Modalities and Recurrence, Socio-economic Burdens
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV DNA and HIV Status | 18 Months | HPV DNA Positivity and HIV Status |
| HPV DNA and Pap Smear Results | 18 Months | Relationship between HPV DNA Positivity and Pap Smear Results |
| Number of HPV Genotypes Isolated by HIV Status | Up to 18 months | Number of HPV Genotypes isolated according to HIV Status |
| Commonest HPV Genotypes Isolated by HIV Status | 18 months | 10 commonest types of HPV isolated according to HIV status |
Countries
South Africa
Participant flow
Recruitment details
All female patients with genital warts referred to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town, South Africa between 1st April 2010 and 30 September 2010. Those who were pregnant or too frail or ill for a gynaecological examination were excluded.
Pre-assignment details
No Applicable.
Participants by arm
| Arm | Count |
|---|---|
| New Cases Newly diagnosed cases of genital warts | 94 |
| Recurrent Cases Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment | 40 |
| Persistent Cases The warts presence after completion of treatment | 22 |
| Total | 156 |
Baseline characteristics
| Characteristic | New Cases | Total | Persistent Cases | Recurrent Cases |
|---|---|---|---|---|
| Age at First Sexual Intercourse 14 or Less (Years) | 9 Participants | 12 Participants | 1 Participants | 2 Participants |
| Age at First Sexual Intercourse 15 - 19 (Years) | 69 Participants | 116 Participants | 14 Participants | 33 Participants |
| Age at First Sexual Intercourse 20 and Above (Years) | 16 Participants | 27 Participants | 6 Participants | 5 Participants |
| Age at First Sexual Intercourse Virgo Intacta (Years) | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized | 28.64 Years | 29.21 Years | 29.91 Years | 30.18 Years |
| Education Level Primary | 13 Participants | 16 Participants | 3 Participants | 0 Participants |
| Education Level Secondary | 67 Participants | 116 Participants | 13 Participants | 36 Participants |
| Education Level Tertiary | 14 Participants | 24 Participants | 6 Participants | 4 Participants |
| HIV Status Negative | 21 Participants | 29 Participants | 5 Participants | 3 Participants |
| HIV Status Positive | 71 Participants | 123 Participants | 16 Participants | 36 Participants |
| HIV Status Unknown | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Marital Status Married | 13 Participants | 21 Participants | 4 Participants | 4 Participants |
| Marital Status Separated / Divorced / Widow | 6 Participants | 13 Participants | 4 Participants | 3 Participants |
| Marital Status Single, Not Sexually Active | 19 Participants | 30 Participants | 5 Participants | 6 Participants |
| Marital Status Single, Sexually Active | 56 Participants | 92 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Female | 94 Participants | 156 Participants | 22 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking No | 77 Participants | 126 Participants | 15 Participants | 34 Participants |
| Smoking Previously | 8 Participants | 14 Participants | 3 Participants | 3 Participants |
| Smoking Yes | 9 Participants | 16 Participants | 4 Participants | 3 Participants |
| Treatment Modalities Electrocautery / Laser Ablation under GA | 17 Participants | 33 Participants | 7 Participants | 9 Participants |
| Treatment Modalities Electrocautery under LA | 68 Participants | 109 Participants | 13 Participants | 28 Participants |
| Treatment Modalities Local Ablation with Tricholoroacetic Acid (TCA) | 7 Participants | 11 Participants | 2 Participants | 2 Participants |
| Treatment Modalities TCA + Electrocautery | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 123 | 5 / 29 | 0 / 4 |
| serious Total, serious adverse events | 0 / 123 | 0 / 29 | 0 / 4 |
Outcome results
Commonest HPV Genotypes Isolated by HIV Status
10 commonest types of HPV isolated according to HIV status
Time frame: 18 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 11 | 46 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 6 | 33 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 89 | 19 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 61 | 16 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 55 | 12 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 62 | 12 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 81 | 9 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 16 | 8 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 18 | 8 Participants |
| HIV Positive | Commonest HPV Genotypes Isolated by HIV Status | HPV 45 | 8 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 16 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 11 | 10 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 62 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 6 | 9 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 45 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 89 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 81 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 61 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 18 | 0 Participants |
| HIV Negative | Commonest HPV Genotypes Isolated by HIV Status | HPV 55 | 0 Participants |
HPV DNA and HIV Status
HPV DNA Positivity and HIV Status
Time frame: 18 Months
Population: Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Positive | HPV DNA and HIV Status | HPV Positive | 96 participants |
| HIV Positive | HPV DNA and HIV Status | HPV Negative | 5 participants |
| HIV Negative | HPV DNA and HIV Status | HPV Positive | 19 participants |
| HIV Negative | HPV DNA and HIV Status | HPV Negative | 2 participants |
| HIV Unknown | HPV DNA and HIV Status | HPV Positive | 4 participants |
| HIV Unknown | HPV DNA and HIV Status | HPV Negative | 0 participants |
HPV DNA and Pap Smear Results
Relationship between HPV DNA Positivity and Pap Smear Results
Time frame: 18 Months
Population: Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Positive | HPV DNA and Pap Smear Results | Normal | 42 Participants |
| HIV Positive | HPV DNA and Pap Smear Results | Low Grade Squamous Intraepithelial Lesion | 59 Participants |
| HIV Positive | HPV DNA and Pap Smear Results | High Grade Squamous Intraepithelial Lesion | 10 Participants |
| HIV Positive | HPV DNA and Pap Smear Results | Atypical Squamous Cell of Undetermined Significanc | 6 Participants |
| HIV Negative | HPV DNA and Pap Smear Results | Atypical Squamous Cell of Undetermined Significanc | 0 Participants |
| HIV Negative | HPV DNA and Pap Smear Results | Normal | 5 Participants |
| HIV Negative | HPV DNA and Pap Smear Results | High Grade Squamous Intraepithelial Lesion | 0 Participants |
| HIV Negative | HPV DNA and Pap Smear Results | Low Grade Squamous Intraepithelial Lesion | 2 Participants |
Number of HPV Genotypes Isolated by HIV Status
Number of HPV Genotypes isolated according to HIV Status
Time frame: Up to 18 months
Population: 119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 2 HPV Genotype | 12 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 5 HPV Genotype | 5 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 4 HPV Genotype | 4 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 15 HPV Genotype | 1 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 6 HPV Genotype | 3 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 1 HPV Genotype | 44 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 11 HPV Genotype | 2 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 7 HPV Genotype | 5 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | No Genotype Isolated but B-Globin Positive | 9 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 3 HPV Genotype | 9 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 8 HPV Genotype | 1 participants |
| HIV Positive | Number of HPV Genotypes Isolated by HIV Status | 9 HPV Genotype | 1 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 8 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 9 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 11 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 15 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 4 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | No Genotype Isolated but B-Globin Positive | 2 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 5 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 2 HPV Genotype | 1 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 6 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 1 HPV Genotype | 14 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 7 HPV Genotype | 0 participants |
| HIV Negative | Number of HPV Genotypes Isolated by HIV Status | 3 HPV Genotype | 2 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 6 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 1 HPV Genotype | 1 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 2 HPV Genotype | 2 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 3 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 4 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 5 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | No Genotype Isolated but B-Globin Positive | 1 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 7 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 8 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 9 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 11 HPV Genotype | 0 participants |
| HIV Unknown | Number of HPV Genotypes Isolated by HIV Status | 15 HPV Genotype | 0 participants |