Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen P… (NCT07645352) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
Zimbabwe300 participantsStarted 2026-06
Plain-language summary
Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.
Who can participate
Age range
25 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 25-49 years old
. Living with HIV
. Intact cervix
. Willing to return to facility at 6 months
. Willing and able to provide informed consent
. Positive hrHPV or VIA test within 3 months of enrollment
. Type 1 transformation zone (TZ1)
. Thermal ablation eligible
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is comparing one probe versus two probes for thermal ablation — can you explain what thermal ablation is, how it's used to treat cervical precancer, and what the practical difference between these two approaches might mean for me?
2Since this trial is specifically for women living with HIV who have tested screen-positive for cervical precancer, can you help me understand how my HIV status affects my risk for HPV-related cervical disease and whether that changes what treatment options make the most sense for me right now?
3The trial is measuring whether HPV is still present at 6 months after treatment — what happens if HPV does persist after ablation, and are there established follow-up treatments available regardless of whether I join this study?
4This trial is listed as 'not yet recruiting' and is based in Zimbabwe — is this study something that would even be geographically accessible to me, or are there similar studies or standard-of-care ablation treatments I should be exploring closer to home?
5Since this is listed as a feasibility study with no specific phase, what does that mean about how much is already known about the safety and effectiveness of thermal ablation for someone in my situation, and would standard treatment outside of a study be a reasonable alternative to consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with persistent HPV at 6 months
Timeframe: From enrollment to follow up at 6 months
. Screened for cervical cancer outside of study in last 6 months
. Currently pregnant or less than 6 weeks postpartum
. Prior diagnosis of cervical cancer
. A history of treatment for cervical precancer
. Total hysterectomy
. Currently receiving treatment for any cancer
. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled