NCT07645378 Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
| NCT ID | NCT07645378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fred Hutchinson Cancer Center |
| Condition | HIV (Human Immunodeficiency Virus) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-10-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-10-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 25-49 years old 2. Living with HIV Inclusion criteria specific to the feasibility study 1. Intact cervix 2. Willing to return to facility at 6 months 3. Willing and able to provide informed consent 4. Positive hrHPV or VIA test within 3 months of enrollment 5. Type 1 transformation zone (TZ1) 6. Thermal ablation eligible Exclusion Criteria: 1. Screened for cervical cancer outside of study in last 6 months 2. Currently pregnant or less than 6 weeks postpartum 3. Prior diagnosis of cervical cancer 4. A history of treatment for cervical precancer 5. Total hysterectomy 6. Currently receiving treatment for any cancer 7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study 8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled
Contact & Investigator
Rachel L Winer, PhD, MPH
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT07645378 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 49 Years, studying HIV (Human Immunodeficiency Virus). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07645378 currently recruiting?
Yes, NCT07645378 is actively recruiting participants. Contact the research team at aloera@fredhutch.org for enrollment information.
Where is the NCT07645378 trial being conducted?
This trial is being conducted at Durban, South Africa.
Who is sponsoring the NCT07645378 clinical trial?
NCT07645378 is sponsored by Fred Hutchinson Cancer Center. The principal investigator is Rachel L Winer, PhD, MPH at University of Washington. The trial plans to enroll 200 participants.
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