Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya

This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks. It is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.

NCT Number	NCT07545746
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: National Cancer Institute (NCI), UNC Department of Obstetrics and Gynecology
Conditions	HIV Infections, HPV Infection, Cervix Cancer, CIN2, CIN3, CIN1, CIN, Cervical Intraepithelial Neoplasia Grade 3 +2 more
Enrollment	140 participants
Start Date	2026-07
Primary Completion	2027-09 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-02