NCT07202936 Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe
| NCT ID | NCT07202936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Uterine Cervical Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-05-03 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Women aged 18-65 years * Positive HIV status confirmed through medical records * Positive test result for any high-risk HPV genotype at preceding cervical cancer screening visit * Cervical pre-cancer treatment required according to Newlands Clinic guidelines * Signed informed consent Exclusion Criteria: * Women with a history or suspicion of cervical cancer * Women with a history of total hysterectomy (no cervix) * Women treated for cervical pre-cancer in the past 12 months * Pregnant women
Contact & Investigator
Margaret Pascoe, MD
PRINCIPAL INVESTIGATOR
Newlands Clinic Women's Health Centre
Frequently Asked Questions
Who can join the NCT07202936 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202936 currently recruiting?
Yes, NCT07202936 is actively recruiting participants. Contact the research team at eliane.rohner@unibe.ch for enrollment information.
Where is the NCT07202936 trial being conducted?
This trial is being conducted at Harare, Zimbabwe.
Who is sponsoring the NCT07202936 clinical trial?
NCT07202936 is sponsored by University of Bern. The principal investigator is Margaret Pascoe, MD at Newlands Clinic Women's Health Centre. The trial plans to enroll 250 participants.