Evidence map›Paper›PMID 39723608›Full record

ArticleInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2025

Safety and adherence to self-administered intravaginal 5-fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV-positive women in Kenya: A phase 1 clinical trial.

Chemtai Mungo, Jackton Omoto, Cirilus Ogollah, Antony Owaya, Mercy Rop, Gershon Rota, Elizabeth A Bukusi, Jennifer H Tang, Lisa Rahangdale

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05362955 (5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05362955 phase1completednot on this map

5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

TypeinterventionalSponsorUNC Lineberger Comprehensive Cancer CenterRan2023 to 2024Enrolled12ConditionsCIN 2/3, HIV InfectionsArmsIntravaginal 5-Fluorouracil (5-FU)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
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  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Chemtai MungoDepartment of Obstetrics and Gynecology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.ORCID https://orcid.org/0000-0002-3655-4721
Jackton OmotoDepartment of Obstetrics and Gynecology, Maseno University School of Medicine, Maseno, Kenya.
Cirilus OgollahCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Antony OwayaCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Mercy RopCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Gershon RotaCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Elizabeth A BukusiCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Jennifer H TangDepartment of Obstetrics and Gynecology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
Lisa RahangdaleDepartment of Obstetrics and Gynecology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.

Funding

Advancing womens reproductive health through research: the UNC WRHR Career Development ProgramK12HD103085 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Benjamin H. Chi, Genevieve S. Neal-Perry · 2020 to 2026
$2.1M
NICHD NIH HHS K12 HD103085Victoria's Secret Global Fund for Women's Cancers Career Development Award, in Partnership with Pelotonia and the American Association of Cancer Research
6 · The paper itself

Abstract

objectiveTo determine the safety, tolerance, and adherence to self-administered intravaginal 5% fluorouracil (5FU) cream as adjuvant therapy following cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) treatment among women living with HIV (WLWH) in Kenya.

methodsA phase I pilot trial was performed among 12 WLWH in Kenya, aged 18-49 years between March 2023 and February 2024 (ClinicalTrial.gov NCT05362955). Participants self-administered 2 g of 5FU intravaginally every other week for eight applications. Safety was assessed using a standardized grading scale, and adherence was evaluated using self-report, inspection of used applicators, and weighing of the study drug.

resultsThe mean age and CD4 count were 43.9 years and 781 cells/mm

conclusionSelf-administered 5FU following CIN2/3 treatment among WLWH in Kisumu, Kenya, was safe, tolerable, and associated with high adherence. Randomized trials are needed to investigate whether adjuvant 5FU can improve treatment outcomes or serve as primary cervical precancer treatment in sub-Saharan Africa. A self-administered therapy may be transformative in increasing access to treatment and, hence, secondary prevention of cervical cancer.

Indexed as

Antimetabolites, AntineoplasticFluorouracilHIV InfectionsUterine Cervical DysplasiaUterine Cervical NeoplasmsAdministration, IntravaginalAdolescentAdultChemotherapy, AdjuvantFemaleHumansKenyaMiddle AgedPilot ProjectsSelf AdministrationYoung AdultAntimetabolites, AntineoplasticFluorouracil5% fluorouracil (5FU) creamcervical precancerhuman papillomaviruslow‐ and middle‐income countriesself‐administered topical therapywomen living with HIV

Identifiers

PMID39723608
PMCPMC12291052

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.