Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen P… (NCT07645378) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
South Africa200 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. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. 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. It will also contribute towards achieving the 90-70-90 goals of the 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 trial is comparing one probe versus two probes for thermal ablation in women living with HIV who have tested positive on cervical cancer screening — given my HIV status and my screening results, is thermal ablation even something my doctor would consider for me right now, or would a different treatment path make more sense first?
2The trial is based in South Africa and hasn't started recruiting yet — is there any realistic way this study could be relevant to my care, or should I be looking for similar trials that are already enrolling closer to where I live?
3Since this is listed as phase 'NA' and is described as a feasibility study, does that mean doctors are still figuring out whether the two-probe approach is safe and practical, rather than already knowing it works better than one probe?
4The main thing this trial is measuring is whether HPV is still present at 6 months after the procedure — what does that tell us about how well thermal ablation is actually working, and how does that compare to what's already known about standard ablation treatment for cervical precancer in women with HIV?
5If I were to consider a study like this in the future once it opens, how would participating affect my regular cervical cancer follow-up care, and would I still be able to get standard treatment if the ablation doesn't clear the precancer?
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