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Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia

NCT05125380UNKNOWNNAINTERVENTIONAL

Summary

The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC). Specific aims are the following: * To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV. * To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort. * To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN). * To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer

Key Facts

Lead Sponsor

Lund University

Enrollment

1200

Start Date

2021-12-01

Completion Date

2023-10-28

Study Type

INTERVENTIONAL

Official Title

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

Interventions

VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)VIA (Visual Inspection with Acetic acid)

Conditions

Cervical CancerSTIHuman Papilloma VirusMicrobiota

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Can give consent, Age above 18

Exclusion Criteria:

* Women who have undergone hysterectomy

Outcome Measures

Primary Outcomes

Sensitivity and specificity of VIA and VIA/VILI as triage test

All HPV pos women will have a cervical biopsy taken

Time frame: 12 weeks

Secondary Outcomes

Prevalence of STI other than HPV

Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis

Time frame: 8 weeks

Vaginal Microbiota composition

Assessed in HPV high risk pos women at initiation, who persist and who clear their infection

Time frame: 24 months

Locations

Adama and Geda Health Center, Ādama, Ethiopia

Linked Papers

2025-08-28

Assessing the feasibility of HPV screening for cervical cancer in pregnant women in Ethiopia

Abstract Pregnant women have historically and are currently being excluded from cervical cancer screening in most low and middle-income countries (LMICs). The aim of this study was to assess the feasibility and outcomes of including pregnant women in a HPV self-sampling-based screening program in Ethiopia. Pregnant women, recruited from a previously established cohort, were included. They answered a questionnaire and provided HPV self-samples. If the woman was HR-HPV positive, she underwent triage with VIA with or without Iodine. If positive in triage, the woman was re-scheduled after delivery for a new exam. Primary outcome was screening participation. The participation rate of pregnant women was 92.1% (117/127) (95% CI 86.0–96.1%). They had the same knowledge about cervical cancer and acceptance rate to the study as their non-pregnant peers. Pregnant women had less history of previous screening (p = 0.08). The HPV prevalence was 25.4% (29/114) in self-samples. 93.1% (27/29) attended follow-up, where only 11 had not delivered, and 54.6% (6/11) had detectable HPV infection in their cervical samples. Including pregnant women in HPV self-sampling-based screening is feasible and highly accepted. The findings support integrating pregnant women into cervical cancer screening programs in to enhance prevention and early detection efforts. Clinical trials ID: NCT05125380.

2024-11-04

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

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

Linked Investigators

Selamawit Fisseha Mekuria

I work as a consultant in the department of Obstetrics and Gynecology at Skåne´s University hospital. Part-time I'm a clinical researcher with a focus on cervicalcancerprevention in LMIC.