An observational study in Uterine Cervical Neoplasms, HIV I Infection and HPV Infection, sponsored by University of Bern. Active, not recruiting at 1 site in Zimbabwe. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of Bern · Observational
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:
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.
Background and Rationale:
Cervical cancer mortality rates in Zimbabwe are among the highest in the world. Cervical cancer disproportionally affects women living with HIV (WLWH). In 2020, the World Health Assembly adopted a strategy to eliminate cervical cancer as a public health problem. To date, global efforts to eliminate cervical cancer have focused on expanding coverage of HPV vaccination, cervical cancer screening, and treatment for cervical pre-cancerous lesions. However, without monitoring treatment outcomes and ensuring that pre-cancerous lesions were successfully removed, the ambitious goal of cervical cancer elimination may not be attainable.
Cervical disease persistence and recurrence after pre-cancer treatment are common in WLWH. Data on the accuracy of post-treatment screening tests to guide clinical management are scarce. In July 2021, the World Health Organization (WHO) released new cervical cancer screening guidelines that propose primary HPV testing for all women. For follow-up of treated WLWH, the WHO guidelines suggest HPV testing at 12 and 24 months and immediate re-treatment for those who test positive. However, HPV is highly prevalent in WLWH, and the predictive value of a positive test for high-risk HPV infection after pre-cancer treatment in WLWH is uncertain but probably low. Therefore, alternative testing strategies such as confirmation of type-specific HPV persistence, extended HPV genotyping, and combining HPV testing with DNA methylation triage need to be explored. DNA methylation occurs as HPV infection progresses to cervical pre-cancer and cancer. Thus, methylation tests may distinguish between transient and persistent HPV infections that will advance to cancer. An advantage of molecular methylation tests is that they can be automated and are less subjective than morphological tests.
Objective(s):
Primary objectives:
Main secondary objectives:
Study design:
The project will analyze data from a prospective cohort study of 250 WLWH aged 18-65 years treated for cervical pre-cancer at the Newlands Clinic Women's Health Centre in Harare, Zimbabwe. The cohort study will follow all women every six months for 24 months to evaluate post-treatment monitoring and cervical disease outcomes.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 168 is below the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women living with HIV who are high-risk HPV positive and need cervical pre-cancer treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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