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

Lund University

Status: Enrolling

Conditions: STI; Human Papilloma Virus; Cervical Cancer; Microbiota

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05125380

FBKS 2019-6

Details and patient eligibility

About

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

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Can give consent, Age above 18

Exclusion criteria

• Women who have undergone hysterectomy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

1- Triage arm for HPV pos women

Active Comparator group

Description:

HPV positive women

Treatment:

Diagnostic Test: VIA (Visual Inspection with Acetic acid)

2- Triage arm for HPV pos women

Experimental group

Description:

HPV positive women

Treatment:

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