High-risk HPV Testing With Pap Smear Triage for Cervical Cancer Screening in Women Aged 50 and Older in Ethiopia

Trial details

Who runs it

University Medical Center Groningen

Trial code

NCT07929246

Record updated

10 November 2026

Original description

The goal of this observational study is to estimate how common high-risk human papillomavirus (hrHPV) infection is in women aged 50 and older in urban Ethiopia, and which HPV types are present. It will also compare how accurately hrHPV testing alone, or combined with a Pap smear (cytology), identifies serious precancerious changes of the cervix (called CIN2 or worse). A biopsy (a small tissue sample from the cervix) will confirm these changes.Read full original descriptionShow less

Genotyping and Outcome of hrHPV With cytoLogy Triage for Detection and Evaluation in Older Ethiopian womeN (GOLDEN-Et)

The goal of this observational study is to estimate how common high-risk human papillomavirus (hrHPV) infection is in women aged 50 and older in urban Ethiopia, and which HPV types are present. It will also compare how accurately hrHPV testing alone, or combined with a Pap smear (cytology), identifies serious precancerious changes of the cervix (called CIN2 or worse). A biopsy (a small tissue sample from the cervix) will confirm these changes.

The main questions it aims to answer are:

1. How common is hrHPV infection in women aged 50 and older, and which HPV types are most common? 2. How accurately does hrHPV testing alone, or combined with a Pap smear, identify biopsy-confirmed CIN2 or worse in these women?

After a positive hrHPV result, some women need a follow-up exam of the cervix (colposcopy). Researchers will compare two ways to decide who gets this exam:

Strategy A: All women with a positive hrHPV result get a follow-up exam. Strategy B: Only women with a positive hrHPV result and an abnormal Pap smear get a follow-up exam.

Researchers will apply both strategies to the same group of participants. Participants are not placed in different groups. Researchers will compare how many cases of CIN2 or worse each strategy finds, and how many cases Strategy B misses. They will also compare how many follow-up exams each strategy needs to find one case, how many exams find no CIN2 or worse, and how many exams are needed for every 1,000 women screened.

Participants will:

* Collect their own hrHPV sample with a self-sampling brush * Answer questions about their health and background, such as age, marital status, number of births, smoking, and past screening * If their hrHPV result is positive and they agree to more testing, have a Pap smear, a follow-up exam (colposcopy), and a biopsy

This study is exploratory. Its results will help inform cervical cancer screening for women aged 50 and older in Ethiopia.

Inclusion: Women aged 50 years and older; Eligible for cervical cancer screening according to Ethiopian national guidelines; Able to understand and willing to give informed consent.

Exclusion: Prior hysterectomy with removal of the cervix; Prior cervical cancer diagnosis or treatment.

ClinicalTrials.gov NCT07929246