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

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.

Conditions

• HPV
• Cervical Precancer
• HIV (Human Immunodeficiency Virus)

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

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• University of Cincinnati

  collaborator OTHER

• Frontier Science & Technology Research Foundation, Inc.

  collaborator INDUSTRY

• Emory University

  collaborator OTHER

• Coptic Hope Center

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Rachel L Winer, PhD, MPH · University of Washington

• Margaret M Madeleine, PhD, MPH · Fred Hutchinson Cancer Center

• Leeya Pinder, MD, MPH · University of Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Kenya

Study Locations