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

NCT07202936 | Recruiting

• 2 other identifiers: 2023-00923U01AI069924
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms; HIV I Infection; HPV Infection

Keywords

Cervical pre-cancer treatment; Women living with HIV; Zimbabwe; DNA methylation

Outcome Measures

Primary Outcomes (9)

• Cumulative CIN2+ persistence

  Proportion of participants with histologically confirmed CIN2+ at 6 months after pre-cancer treatment

  6 months

• Cumulative CIN2+ persistence

  Proportion of participants with histologically confirmed CIN2+ up to 12 months after pre-cancer treatment

  12 months

• Cumulative CIN2+ persistence

  Proportion of participants with histologically confirmed CIN2+ up to 18 months after pre-cancer treatment

  18 months

• Cumulative CIN2+ persistence

  Proportion of participants with histologically confirmed CIN2+ up to 24 months after pre-cancer treatment

  24 months

• Cumulative CIN2+ persistence among participants with genotype-specific HPV persistence

  Proportion of participants with histologically confirmed CIN2+ up to 24 months after pre-cancer treatment among participants with genotype-specific HPV persistence in first post-treatment cervical samples

  24 months

• Cumulative CIN2+ persistence among participants with HPV 16 or 18

  Proportion of participants with histologically confirmed CIN2+ up to 24 months after pre-cancer treatment among participants with HPV 16 or 18 in first post-treatment cervical samples

  24 months

• Cumulative CIN2+ persistence among participants with DNA hypermethylation

  Proportion of participants with histologically confirmed CIN2+ up to 24 months after pre-cancer treatment among participants with DNA hypermethylation in first post-treatment cervical samples

  24 months

• Cumulative CIN2+ persistence among participants with any high-risk HPV

  Proportion of participants with histologically confirmed CIN2+ up to 24 months after pre-cancer treatment among participants with any high-risk HPV in first post-treatment cervical samples

  24 months

• Association of baseline factors with CIN2+ persistence

  Analysis of whether baseline factors-including CD4 cell count, HIV RNA viral load, HPV genotype, vaginal microbiome composition, sexually transmitted infections, cervical lesion grade, or type of pre-cancer treatment-are associated with cumulative CIN2+ persistence up to 24 months after pre-cancer treatment

  24 months

Secondary Outcomes (5)

• Association of baseline factors with genotype-specific HPV persistence

  24 months

• Agreement beyond chance between HPV test results in paired cervical and urine samples

  0 months (baseline)

• Agreement beyond chance between HPV test results in paired cervical and urine samples

  6 months

• Agreement beyond chance between DNA methylation test results in paired cervical and urine samples

  0 months (baseline)

• Agreement between beyond DNA methylation test results in paired cervical and urine samples

  6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women living with HIV who are high-risk HPV positive and need cervical pre-cancer treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Women's Health Centre at Newlands Clinic

Harare, Zimbabwe

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Cervical biopsies within the transformation zone will be obtained from all women as the reference standard. * Nurse-collected cervical and self-collected first-void urine samples will be obtained for HPV and DNA methylation testing. * Blood will be drawn for CD4 cell count and HIV RNA viral load analyses, and a vaginal swab will be collected for microbiome analyses.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Pascoe, MD

  Newlands Clinic Women's Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliane Rohner, MD, MSc

CONTACT

+41 31 684 35 23; eliane.rohner@unibe.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: October 2, 2025
• Study Start: May 3, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1)