Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial

BACKGROUND: Condom use can reduce the risk of infection by human papillomavirus (HPV). Furthermore, it has been suggested that condom use can increase the regression rate of cervical lesions. In Denmark, women with cervical intraepithelial neoplasia grade 2 (CIN2) and a future wish to conceive are not treated immediately but are followed up by a gynecologist about 6 months later. The aim of this project was to determine if advising women to have their male partners to use a condom during sexual intercourse in the follow-up period can increase the regression rate of CIN2. METHODS/DESIGN: This is a randomized clinical trial of women with CIN2. The intervention group was advised to use condoms between the date of diagnosis and the date of their follow-up visit. The control group received standard care. Cervical samples were tested for HPV. The primary endpoint will be the intention-to-treat analysis with the relative rate of CIN2 regression between the intervention group and the control group. Regression is defined as <CIN2 at the follow-up visit. In addition, a per-protocol analysis of the regression rate in women adhering to condom use compared with the control group will be performed. The secondary endpoint will be the HPV-clearance rate in the condom group. DISCUSSION: If condom use for 6 months can enhance the regression of cervical lesions, then more women can be spared conization. This is an efficient treatment of cervical lesions but is associated with an increased risk of preterm delivery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02907333. Registered on 14 September 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3564-4) contains supplementary material, which is available to authorized users.