Actively Recruiting
Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe: a Cohort Study
Led by University of Bern · Updated on 2025-10-02
250
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University of Bern
Lead Sponsor
K
Krebsforschung Schweiz, Bern, Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve treatment outcomes for cervical pre-cancer in women living with HIV (WLWH), with a focus on those in low and middle income countries like Zimbabwe. It seeks to understand the risk of disease coming back or persisting after treatment and to evaluate the effectiveness of various HPV and DNA methylation tests for monitoring these outcomes. The study responds to the need for better post-treatment monitoring guidelines to support global efforts in cervical cancer elimination. Participants are women aged 18 to 65 treated for cervical pre-cancer. Researchers will collect cervical biopsies for tissue analysis and samples for HPV genotyping and DNA methylation testing. The study will follow these women every six months for two years to track disease persistence or recurrence and assess the predictive value of different testing methods using both cervical and urine samples. During the study, women will attend visits every six months for up to 24 months. At each visit, samples will be collected and tested to monitor cervical disease status. Researchers will measure outcomes including the rate of persistent or recurrent disease (CIN2+) at 6, 12, 18, and 24 months and examine how well HPV and DNA methylation tests predict disease status. The study also evaluates the agreement between test results from cervical and urine samples, with ongoing monitoring to better understand post-treatment outcomes in this population.
CONDITIONS
Brief Title
Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18-65 years
- Confirmed positive HIV status through medical records
- Positive test for any high-risk HPV genotype at previous cervical cancer screening
- Require cervical pre-cancer treatment according to Newlands Clinic guidelines
- Signed informed consent
You will not qualify if you...
- History or suspicion of cervical cancer
- History of total hysterectomy (no cervix)
- Treated for cervical pre-cancer in the past 12 months
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants who have been treated for cervical pre-cancer are monitored to evaluate post-treatment outcomes and cervical disease status.
Visits every 6 months for 24 months
Trial Site Locations
Total: 1 location
1
Women's Health Centre at Newlands Clinic
Harare, Zimbabwe
Actively Recruiting
Research Team
E
Eliane Rohner, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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