Evidence map›Paper›PMID 39362749›Full record

Trial reportInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2024

Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial.

Selamawit Fisseha Mekuria, Habtamu Biazin, Tamrat Abebe, Christer Borgfeldt, Nahom Assegid, Adane Mihret, Reta Obsi Nemomsa, Ola Forslund, Mats Jerkeman

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05125380 (Evaluation of an Human Papillomavirus), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05125380 naunknown statusnot on this map

Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia

TypeinterventionalSponsorLund UniversityRan2021 to 2024Enrolled1,200ConditionsCervical Cancer, STI, Human Papilloma Virus, MicrobiotaArmsVIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine), VIA (Visual Inspection with Acetic acid)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Selamawit Fisseha MekuriaDepartment of Medical Oncology, Lund University Faculty of Medicine, Lund, Sweden selamawit.mekuria@med.lu.se.ORCID 0000-0003-1120-1054
Habtamu BiazinDepartment of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia.
Tamrat AbebeDepartment of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia.
Christer BorgfeldtDepartment of Obstetrics and Gynecology, and Department of Biomedical and Clinical Sciences, Linköping University, Linkoping, Sweden.
Nahom AssegidArmauer Hansen Research Institute, Addis Ababa, Ethiopia.
Adane MihretDepartment of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia.
Reta Obsi NemomsaDepartment of Obstetrics and Gynaecology, Adama General Hospital and Medical College, Adama, Ethiopia.
Ola ForslundDivision of Medical Microbiology, Lund University Faculty of Medicine, Lund, Sweden.
Mats JerkemanDepartment of Medical Oncology, Lund University Faculty of Medicine, Lund, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling.

methodThis two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard.

results22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative.

conclusionVIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone. TRIAL REGISTRATION NUMBER: NCT05125380.

Indexed as

Acetic AcidIodidesPapillomavirus InfectionsTriageUterine Cervical NeoplasmsAdultEarly Detection of CancerEthiopiaFemaleHumansMiddle AgedPapillomaviridaeSensitivity and SpecificityUterine Cervical DysplasiaVaginal SmearsYoung AdultAcetic AcidIodidesLugol's solutionCervix Uteri

Identifiers

PMID39362749
PMCPMC11672005

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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.