NCT05413811Completed
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 7 Jun 2022
- Start date
- 22 Mar 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT05413811
What you commit to
- Study type: Interventional
- Participants enrolled: 180
- From 22 Mar 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- have an active sexually transmitted infection (women may participate once treated)
- have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer
Other
- pregnancy,
- breastfeeding,
- intend to become pregnant within 180 days of enrollment
- have a surgically absent cervix
- have a medical comorbidity that would interfere with study participation.
Who the study is looking for
- Confirmed HIV-1 infection
- On antiretroviral therapy (ART), for at least 90 days prior to enrollment
- Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital Coordinator of this site? Confirm its status | Westdene | South Africa | Unknown status |
Related publications
- Efficacy of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Secondary Outcomes from the ACT 2 Randomized Controlled Trial.medRxiv · 2026 · PMID 41890998
- Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Primary Outcomes from the ACT 2 Randomized Trial.medRxiv · 2026 · PMID 41891028
- Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2).Contemp Clin Trials · 2026 · PMID 41780745
This page is information, not medical advice. Discuss any trial with your doctor.