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

NCT07202936RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

University of Bern

Enrollment

250

Start Date

2024-05-03

Completion Date

2026-05-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Uterine Cervical NeoplasmsHIV I InfectionHPV Infection

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Cumulative CIN2+ persistence

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

Time frame: 6 months

Cumulative CIN2+ persistence

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

Time frame: 12 months

Cumulative CIN2+ persistence

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

Time frame: 18 months

Cumulative CIN2+ persistence

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 24 months

Secondary Outcomes

Association of baseline factors with genotype-specific HPV 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 genotype-specific HPV persistence up to 24 months after pre-cancer treatment

Time frame: 24 months

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

Agreement between paired cervical and urine samples for HPV detection (type-specific and high-risk), measured before treatment and accounting for expected agreement by chance

Time frame: 0 months (baseline)

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

Agreement between paired cervical and urine samples for HPV detection (type-specific and high-risk), measured 6 months after treatment and accounting for expected agreement by chance

Time frame: 6 months

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

Agreement between paired cervical and urine samples for DNA methylation testing, measured before treatment and accounting for expected agreement by chance

Time frame: 0 months (baseline)

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

Agreement between paired cervical and urine samples for DNA methylation testing, measured 6 months after treatment and accounting for expected agreement by chance

Time frame: 6 months

Locations

Women's Health Centre at Newlands Clinic, Harare, Zimbabwe

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

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