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

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

Inclusion Criteria5

  • 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 Criteria4

  • 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

Locations(1)

Women's Health Centre at Newlands Clinic

Harare, Zimbabwe

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NCT07202936


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