Trial · NCT05413811
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
NCT05413811, Not applicable, Completed, UNC Lineberger Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV. Trials, record NCT05413811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05413811
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
- NCT number
- NCT05413811
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 180 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Cervical Cancer, CIN2, CIN3, Human Immunodeficiency Virus, Human Papillomavirus
- Interventions
- 5 Fluorouracil (5 FU) Cream, Placebo
- First posted
- 2022-06-10
- Last updated
- 2026-08-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Retained in the Study Through Week 24 | Baseline (Week 0) through Week 24 | Retention was defined as the number of participants who remained in follow-up and completed the Week 24 study visit. The number and percentage of participants retained at Week 24 were reported for each study arm. |
| Primary | Number of Participants With ≥80% Acceptability Summary Score at Week 10 | Week 10 | Acceptability was defined as a summary score ≥80% on a 7-item questionnaire administered at Week 10. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm. |
| Primary | Number of Participants With ≥80% Acceptability Summary Score by Week 24 | Week 24 | Acceptability was defined as a summary score ≥80% on the same 7-item questionnaire administered at Week 24. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm. |
| Primary | Number of Participants Experiencing a Treatment-Related Grade ≥2 Adverse Event or Grade 1 Genital Lesion | Week 4 (randomization) through Week 24 | A safety event was defined as any Grade 2 or higher adverse event (AE), or any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to the study drug. Adverse events were assessed from Week 4 (randomization) through Week 24. The number and percentage of participants experiencing at least one such event were reported for each study arm. |
| Primary | Number of Participants Unable or Unwilling to Apply ≥50% of Study Cream Doses Due to Dose-Limiting Toxicity | Week 4 (randomization) through Week 18 | A tolerability event was defined as inability or unwillingness to apply ≥4 of 8 planned doses of the study treatment due to a dose-limiting toxicity (DLT). A DLT was defined as (1) any Grade 2 or higher AE, or (2) any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to study drug and resulted in an investigator decision to reduce the number of doses or discontinue study treatment. Tolerability was assessed from randomization through the dosing period (Week 18), with follow-up censored at the last tolerability assessment for participants who exited early without experiencing an event. The number and percentage of participants experiencing a tolerability event were reported for each study arm. |
| Primary | Number of Participants Adherent to ≥75% of Study Cream Doses Based on Ultraviolet Inspection | Week 4 (randomization) through Week 24 | Adherence was defined as administration of at ≥6 of 8 planned doses of study treatment, as determined by ultraviolet inspection of returned applicators. Applicator collection occurred through Week 24, including for participants who completed dosing earlier, to allow complete ascertainment of dose use. Each applicator was independently assessed by ≥2 reviewers; in cases of disagreement, a third reviewer adjudicated the result. Participants were classified as adherent if ≥6 applicators showed evidence of use. Participants who did not meet this threshold, including those with missing or incomplete applicator data, were classified as non-adherent. The number and percentage of participants meeting this definition were reported for each study arm. |
| Secondary | Percent of Participants With CIN2/3 at Baseline Who Regressed to CIN1 or Normal Histology at Week 24 | Baseline (Week 0) through Week 24 | The analysis population included all randomized participants, all of whom had CIN2 or CIN3 at baseline (Week 0) confirmed by loop electrosurgical excision procedure (LEEP) histology. The analysis population was restricted to participants who completed the Week 24 visit and had cervical biopsy results available. This included 89 participants in the placebo arm and 81 participants in the 5FU arm. Regression was defined as improvement from CIN2 or CIN3 at baseline to CIN1 or normal histology at Week 24, as assessed by cervical biopsy. Participants missing Week 24 data were not included and not considered to have experienced CIN2/3 regression. The number and percentage of participants meeting this definition were reported for each study arm. The Wilson score method was used to estimate 95% confidence intervals around percentages. |
| Secondary | Percent of Participants With Baseline High-Risk HPV Who Achieved Genotype-Specific Clearance at Week 24 | Baseline (Week 0) through Week 24 | The analysis population was restricted to participants with at least one high-risk HPV (hrHPV) genotype detected at baseline and with hrHPV results available at Week 24. A total of 69 participants in the 5FU arm and 80 participants in the placebo arm met these criteria. High-risk HPV clearance was defined as absence at Week 24 of all hrHPV genotypes detected at baseline. Participants without baseline hrHPV infection or without Week 24 hrHPV results were excluded from this analysis. The number and percentage of participants meeting this definition were reported for each study arm. The Wilson score method was used to estimate 95% confidence intervals around percentages. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA250850 | Acceptability and feasibility of combination treatment for cervical precancer among South Africa women living with HIV | CHIBWESHA, CARLA J; RAHANGDALE, LISA | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 2020 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05413811
GET https://conductscience.org/api/trials/v1/NCT05413811/registered