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NOT YET RECRUITING
NCT07468695
NA

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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. 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.

Official title: Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV

Key Details

Gender

FEMALE

Age Range

25 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03

Completion Date

2027-05-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

PROCEDURE

Thermal ablation (TA) with 1 probe

Undergo TA with 1 probe

PROCEDURE

Thermal ablation (TA) with 2 probes

Undergo TA with 2 probes

Locations (1)

Coptic Hope Center

Nairobi, Kenya