Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV (ACT2)

February 11, 2026 updated by: UNC Lineberger Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are currently no medical therapies recommended to promote the clearance of humanpapilloma virus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV) -infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia [CIN2/3]), and invasive cervical cancer also occur more frequently in HIV infected women.

This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Johannesburg
      • Westdene, Johannesburg, South Africa, 2092
        • Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • pregnancy,
  • breastfeeding,
  • intend to become pregnant within 180 days of enrollment
  • have an active sexually transmitted infection (women may participate once treated)
  • have a surgically absent cervix
  • have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer
  • have a medical comorbidity that would interfere with study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5 Fluorouracil Cream
The participants will receive 8 doses of intravaginal 5 Fluorouracil Cream.
Drug: 5 Fluorouracil (5 FU) Cream
Intravaginal topical chemotherapy, 5-fluorouracil cream
Other Names:
  • Carac
  • Efudex
  • Fluoroplex
Placebo Comparator: Placebo Cream
The participants will receive 8 doses of intravaginal placebo cream.
Drug: Placebo
Intravaginal topical placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of subjects adhered to and retained in the study
Time Frame: Up to 24 weeks
The feasibility of the combination of surgical excision followed by adjuvant 5FU for the treatment of CIN2/3 among HIV-infected women will be evaluated using the number of subjects adhered to and retained in the study.
Up to 24 weeks
The number of participants who found the intervention acceptable
Time Frame: week 10 to week 24
The acceptability of the combination of surgical excision followed by adjuvant 5FU for the treatment of CIN2/3 among HIV-infected women will be assessed through a participant questionnaire administered at midline and end of the study.
week 10 to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants with CIN2 or CIN 3 that regressed to CIN1
Time Frame: 24 weeks
Efficacy of combination treatment for CIN2/3 will be assessed as the number of subjects with CIN2 or CIN3 regressed to CIN1 or normal histology.
24 weeks
The percentage of participants who demonstrate clearance of high-risk HPV
Time Frame: 24 weeks
Efficacy of combination treatment for HPV will be assessed as the percentage of women in each study arm who demonstrate clearance of high-risk HPV between baseline and 24 weeks.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Carla Chibwesha, MD, MSc, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGHID12046
  • 1R01CA250850-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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