RecruitingNCT07202936

Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe

Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe: a Cohort Study

Sponsor

University of Bern

Enrollment

250 participants

Start Date

May 3, 2024

Study Type

OBSERVATIONAL

Conditions

Uterine Cervical Neoplasms HPV Infection HIV I Infection

Summary

The goal of this observational study is to improve cervical pre-cancer treatment outcomes among women living with HIV (WLWH), particularly in low and middle income countries (LMICs), by generating the evidence needed for post-treatment monitoring guidelines. The main questions it aims to answer are: * What is the risk of disease recurrence/persistence after cervical pre-cancer treatment among women living with HIV in Zimbabwe? * What is the predictive value of different human papillomavirus (HPV) and DNA methylation testing strategies for monitoring cervical disease recurrence/persistence after pre-cancer treatment? Participants will have cervical biopsies taken for histological assessment and cervical samples for HPV genotyping and DNA methylation testing. Researchers will follow all participating women every six months for 24 months to evaluate post-treatment monitoring and cervical disease outcomes.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is examining why cervical pre-cancer treatments sometimes fail in women living with HIV in Zimbabwe. Researchers want to understand how often treatment doesn't work, and what factors — such as HPV type or immune status — are linked to those failures, so that care can be improved for this population. **You may be eligible if...** - You are a woman aged 18–65 years - You are living with HIV (confirmed by medical records) - You tested positive for a high-risk type of HPV at your last cervical cancer screening - You have been identified as needing treatment for cervical pre-cancer according to clinic guidelines - You have signed informed consent **You may NOT be eligible if...** - You have a history or suspicion of cervical cancer (not just pre-cancer) - You have had your uterus and cervix fully removed (total hysterectomy) - You have been treated for cervical pre-cancer within the past 12 months - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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