Fluorouracil cream after cervical ablation for HPV in Kenyan women with HIV
Tests 5-fluorouracil cream against placebo after cervical treatment in women with HIV.
Plain-language title generated from the registry record
Registry title: Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
Key facts
- Where
- Kisumu, KenyaSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women living with HIV in Kenya who have a positive HPV test. It tests a 5-fluorouracil cream used at home after thermal ablation treatment.
- Age
- 25 years or older
- Sex
- Women only
- Disease stage
- Positive HPV screening test result; no history of cancer of the cervix, vulva or anus
- Earlier treatment
- Must have been on antiretroviral therapy (ART) for at least 60 days before joining; must not currently use immune-suppressing medicines
- Biomarker or test result
- Known HIV-positive status and a positive HPV screening test
Main reasons for not taking part
- Currently pregnant or breastfeeding
- History of cervical, vulvar or anal cancer
- Current use of immune-suppressing medicines
- Total hysterectomy in the past
- Known allergy to 5FU
This trial only enrols participants living with HIV. The registry sentence this rests on: Known HIV-positive status
Read by machine on 9 November 2026.
Where in Kenya
- Maseno UniversityKisumu, KenyaNo longer taking part
- Nyanza Reproductive Health SocietyKisumu, KenyaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UNC Lineberger Comprehensive Cancer Center
- Trial code
- NCT07545746
- Record updated
- 27 August 2026
- Original description
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.Read full original descriptionShow less
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya : The ASCEND Trial
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.
Inclusion: Women aged 25 years or older; Known HIV-positive status; On antiretroviral therapy (ART) for at least 60 days prior to enrollment; Positive HPV screening test screening result; Able to provide informed consent in English, Swahili, or Dholuo; Agree to use dual contraception during dosing phase if of childbearing potential; Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria; Current pregnancy or breastfeeding; History of anogenital cancer (cervical, vulvar, or anal); Current use of immunosuppressive medications; History of total hysterectomy; Known allergy to 5FU; Medical comorbidity that would interfere with study participation; Unwilling or unable to use contraception during study participation.