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

Sponsor

Lund University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05125380

Collaborator

Addis Ababa University (Other), Armauer Hansen Research Institute, Ethiopia (Other), Adama Hospital Medical College, Ethiopia (Other)

1,200

Enrollment

Location

Arms

35.8

Anticipated Duration (Months)

33.5

Patients Per Site Per Month

Study Details

Study Description

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 and Neisseria gonorrhoeae and their effect on the quality of VIA.
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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer STI Human Papilloma Virus Microbiota	Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) Diagnostic Test: VIA (Visual Inspection with Acetic acid)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 6, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1- Triage arm for HPV pos women HPV positive women	Diagnostic Test: VIA (Visual Inspection with Acetic acid) A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.
Experimental: 2- Triage arm for HPV pos women HPV positive women	Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) 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.

Arm

Intervention/Treatment

Active Comparator: 1- Triage arm for HPV pos women

HPV positive women

Diagnostic Test: VIA (Visual Inspection with Acetic acid)

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

Experimental: 2- Triage arm for HPV pos women

HPV positive women

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

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.

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of VIA and VIA/VILI as triage test [12 weeks]
All HPV pos women will have a cervical biopsy taken

Secondary Outcome Measures

Prevalence of STI other than HPV [8 weeks]
Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis
Vaginal Microbiota composition [24 months]
Assessed in HPV high risk pos women at initiation, who persist and who clear their infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Can give consent, Age above 18

Exclusion Criteria:

Women who have undergone hysterectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adama and Geda Health Center	Ādama		Ethiopia

Sponsors and Collaborators

Lund University
Addis Ababa University
Armauer Hansen Research Institute, Ethiopia
Adama Hospital Medical College, Ethiopia

Investigators

Principal Investigator: Adane Mihret, PhD, Armauer Hansen Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lund University

ClinicalTrials.gov Identifier:

NCT05125380

Other Study ID Numbers:

FBKS 2019-6

First Posted:

Nov 18, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lund University

LMIC Lowe Middle income country

Screening

Vaginal microbiota

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Nov 18, 2021