NCT05125380

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

October 7, 2021

Last Update Submit

November 1, 2023

Conditions

Cervical CancerSTIHuman Papilloma VirusMicrobiota

Keywords

LMIC Lowe Middle income countryScreeningVaginal microbiota

Outcome Measures

Primary Outcomes (1)

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

    All HPV pos women will have a cervical biopsy taken

    12 weeks

Secondary Outcomes (2)

  • Prevalence of STI other than HPV

    8 weeks

  • Vaginal Microbiota composition

    24 months

Study Arms (2)

1- Triage arm for HPV pos women

ACTIVE COMPARATOR

HPV positive women

Diagnostic Test: VIA (Visual Inspection with Acetic acid)

2- Triage arm for HPV pos women

EXPERIMENTAL

HPV positive women

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

Interventions

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

A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix.

2- Triage arm for HPV pos women
VIA (Visual Inspection with Acetic acid)DIAGNOSTIC_TEST

A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.

1- Triage arm for HPV pos women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can give consent, Age above 18

You may not qualify if:

  • Women who have undergone hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adama and Geda Health Center

Ādama, Ethiopia

RECRUITING

Related Publications (2)

  • Mekuria S, Assiged N, Biazin H, Borgfeldt C, Abebe T, Mihret A, Forslund O, Jerkeman M. Assessing the feasibility of HPV screening for cervical cancer in pregnant women in Ethiopia. Sci Rep. 2025 Aug 28;15(1):31771. doi: 10.1038/s41598-025-15957-y.

    PMID: 40877387DERIVED

  • Mekuria SF, Biazin H, Abebe T, Borgfeldt C, Assegid N, Mihret A, Obsi Nemomsa R, Forslund O, Jerkeman M. 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. Int J Gynecol Cancer. 2024 Nov 4;34(11):1691-1697. doi: 10.1136/ijgc-2024-005694.

    PMID: 39362749DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCommunicable DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adane Mihret, PhD

    Armauer Hansen Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selamawit Mekuria, MD

CONTACT

+46720123974selamawit.mekuria@med.lu.se

Mats Jerkeman, MD, PhD

CONTACT

+46704973507mats.jerkeman@med.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 18, 2021

Study Start

December 1, 2021

Primary Completion

October 28, 2023

Study Completion

September 1, 2024

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)