Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV I Infection | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (9)
- measure
- Cumulative CIN2+ persistence
- timeFrame
- 6 months
- description
- Proportion of participants with histologically confirmed CIN2+ at 6 months after pre-cancer treatment
- measure
- Cumulative CIN2+ persistence
- timeFrame
- 12 months
- description
- Proportion of participants with histologically confirmed CIN2+ up to 12 months after pre-cancer treatment
- measure
- Cumulative CIN2+ persistence
- timeFrame
- 18 months
- description
- Proportion of participants with histologically confirmed CIN2+ up to 18 months after pre-cancer treatment
- measure
- Cumulative CIN2+ persistence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available