Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS2 Kenya

Starting soon · Not applicable

Conditions studied: HIV (Human Immunodeficiency Virus), HPV, Cervical Precancer

In brief

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. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among 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.

Key facts

Study ID

NCT07468695

Run by

Fred Hutchinson Cancer Center

People needed

300

Starts

2026-03-01

Expected to finish

2027-05-31

Last updated by the study team

2026-03-12

Who can join

Age: 25 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 25-49 years old
• Living with HIV
• Inclusion criteria specific to the feasibility study
• 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

You may not qualify if…

• 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

Where it is running

• Coptic Hope Center — Nairobi, Kenya

Full record on ClinicalTrials.gov

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