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

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. 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.

Conditions

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

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

• University of California, San Francisco

  collaborator OTHER

• University of Zimbabwe Clinical Research Centre (UZCRC)

  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

2026-06-30

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Zimbabwe

Study Locations