Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 6 months
      after the diagnosis with new examinations. The regression rate is based solely on the woman's
      own ability to clear the cervical lesions. The use of condoms has shown a relatively good
      protective effect against Human Papillomavirus (HPV) infection. It has furthermore been
      indicated that condoms increase the regression rate of cervical lesions.

      The hypothesis of this study is that the regression rate of cervical intraepithelial
      neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up period
      of 6 months.
    

Detailed description: 
      Use of condoms has shown a considerable protective effect, when used correctly and
      consistently, against several sexually transmitted infections (STI), including HIV virus,
      trichomoniasis, chlamydia, and gonorrhea. It has been indicated that use of condoms also
      offers a relatively good protection against HPV infections. It is furthermore indicated that
      use of condoms in women with CIN may increase the regression rate of these lesions.

      The aim of this randomized controlled trial is to determine if advising women to use condoms
      during the follow-up period after a CIN2 diagnosis will increase the regression rate. The
      advice is based on the presumption that condom use will prevent HPV-infection and reinfection
      to some extent and thereby allow the immune system to clear the HPV-infection and "repair"
      the CIN-lesion. Based on the literature, we expect regression in non-condom users to be
      around 22% and regression in condom-users to be 2.5 times larger.

      The clinical trial will be conducted as a randomized non-blinded controlled trial. The study
      will be conducted at hospital- and gynecological outpatient clinics in Central Region Denmark
      and Region Zealand.

      The gynaecologists will obtain oral and written consent from women with an abnormal cytology
      to allow the project physician to contact them by telephone. The written consent will be
      compared to a list from the national pathology register for all diagnosed CIN2 in the
      relevant regions. If there is a match between the two documents, the gynecologists will be
      contacted to find out if the woman has been informed about the biopsy result and a follow-up
      after 6 months has been decided. If this is the case, the woman will be included in the study
      and randomized.

      We expect 700 women to be randomized into an intervention- and a control arm. Women in the
      intervention arm will receive information about the project by telephone by the project
      physician. The intervention arm will thereafter be subdivided into a condom group and a
      non-condom group based on the women's acceptance of the intervention. Women in the condom
      group will be provided with free condoms for the entire study period. The project physician
      will not contact women in the control group.

      From the routine samples taken at the first visit and at the follow-up examination, an HPV
      test will be requested from the pathology departments for the women in the condom group. The
      women are also asked to fill out a questionnaire at the follow-up. The information from the
      questionnaire is used to estimate compliance to the condom use and to have background
      information about the women in the condom group.

      The study is approved by the Data Protection Agency and the Ethical Committee of the Capital
      Region of Denmark. The total period of time in which the trial is planned to include women is
      one year having the last woman to her follow-up visit 18 months after the beginning of the
      trial. The inclusion period is expected to commence 15.09.16 and end 15.09.17.

      Randomization will be conducted electronically by the statistician of the department but
      neither the investigator nor the patient will be blinded as it is not possible for this study
      design. Data for the study will be collected from registers and from the questionnaires. All
      final results from the study will be published in relevant international journals.

      The project is supported by funds and we have received a sponsorship for condoms. The
      sponsors had no influence on the study design, and will have no influence on the data
      collection, analysis and reporting.
    

Intervention name(s): Advice to use condoms
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Condom use; Human Papillomavirus; Conization