Anogenital Wart Burden and Cost of Illnesses

Mahidol University

Status: Completed

Conditions: Warts

Study type: Observational

Funder types: Other

Identifiers

NCT00749294

THALS1570

Details and patient eligibility

About

The study will be a prospective study of patients presenting with anogenital warts. The objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.

Full description

An observational study, multiple visit, 2-center study will be conducted in Rajavithi General Hospital, and Bangrak Hospital. One hundred and fifty subjects will be enrolled from both hospitals. Anogenital wart patients presented in Rajavithi General Hospital and the STI clinic at Bangrak Hospital will be recruited prospectively. All patients will be treated according to standard medical guidelines or usual care of the institutes. After the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. At month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. All patients will be followed for 6 months under the same schedule.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is 18 years of age or older and has anogenital warts
• Physician confirmed clinical diagnosis of anogenital warts
• Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent
• Subject will be available for the study follow up period

Exclusion criteria

• Subject is unable to give informed consent
• Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI

Trial design

150 participants in 1 patient group

Observation