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Randomized Controlled Trial
. 2024 Nov 4;34(11):1691-1697.
doi: 10.1136/ijgc-2024-005694.

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  1 , Habtamu Biazin  2   3 , Tamrat Abebe  2 , Christer Borgfeldt  4 , Nahom Assegid  3 , Adane Mihret  2   3 , Reta Obsi Nemomsa  5 , Ola Forslund  6 , Mats Jerkeman  7
Affiliations
Randomized Controlled Trial

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 et al. Int J Gynecol Cancer. .

Abstract

Background: Most 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.

Method: This 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.

Results: 22.4% (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.

Conclusion: VIA 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.

Keywords: Cervix Uteri.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Consort 2010 flow diagram.
Figure 2
Figure 2. Area under the curve for visual inspection with acetic acid (VIA) with and without iodine (VILI). ROC, receiver operating curve.
See this image and copyright information in PMC

References

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