Cervical pre-cancer treatment failure in women living with HIV in Zimbabwe
Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe: a Cohort Study
This study will see if HPV genotyping and DNA methylation tests can help detect whether cervical pre-cancer returns after treatment in women living with HIV in Zimbabwe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Harare) |
| Trial ID | NCT07202936 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll women living with HIV who require treatment for cervical pre-cancer at Newlands Clinic and collect cervical biopsies and samples for HPV genotyping and DNA methylation testing. Participants will be followed every six months for 24 months with clinical exams and repeat testing to identify disease persistence or recurrence. The study will compare conventional HPV testing, type-specific HPV persistence, extended genotyping, and combined HPV plus DNA methylation strategies for predicting post-treatment outcomes. Results are intended to inform post-treatment monitoring guidelines for low- and middle-income settings.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–65 who are living with HIV, have a recent positive high-risk HPV test, require cervical pre-cancer treatment per Newlands Clinic guidelines, and can consent to 24 months of follow-up.
Not a fit: Women with suspected or confirmed invasive cervical cancer, a history of total hysterectomy, treatment for cervical pre-cancer within the past 12 months, pregnant women, or those unable to attend regular follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could lead to more accurate post-treatment monitoring and earlier detection of recurrent cervical disease in women living with HIV.
How similar studies have performed: Previous work shows HPV testing is useful for post-treatment follow-up and emerging studies suggest DNA methylation may improve specificity, but evidence in women living with HIV and in low-income settings remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Harare
- Women's Health Centre at Newlands Clinic — Harare, Zimbabwe (Recruiting)
Study contacts
- Principal investigator: Margaret Pascoe, MD — Newlands Clinic Women's Health Centre
- Study coordinator: Eliane Rohner, MD, MSc
- Email: eliane.rohner@unibe.ch
- Phone: +41 31 684 35 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.