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Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-10-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later May 31, 2027 → Dec 31, 2027
See other at-risk trials from Fred Hutchinson Cancer Center

Amendment history

2026-09-03
critical
Study Status v1
Primary completion pushed: 2027-05-31 → 2027-12-31
Completion pushed: 2027-05-31 → 2027-12-31
Start date2026-06→2026-10
2026-06-09
minor
Original filing
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.
Trial Details
NCT Number NCT07645352
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: University of Washington, National Cancer Institute (NCI), University of Cincinnati, Frontier Science & Technology Research Foundation, Inc., University of California, San Francisco, University of Zimbabwe Clinical Research Centre (UZCRC)
Conditions HIV (Human Immunodeficiency Virus), HPV, Cervical Precancer, Cervical Neoplasia
Enrollment 300 participants
Start Date 2026-10-15
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-24