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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

25-49 years old

Living with HIV

Intact cervix

Willing to return to facility at 6 months

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Thermal ablation (TA) with 1 probe
  • Thermal ablation (TA) with 2 probes

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

University of Washington

Collaborator

National Cancer Institute (NCI)

Collaborator

University of Cincinnati

Collaborator

Frontier Science & Technology Research Foundation, Inc.

Collaborator

University of California, San Francisco

Collaborator

University of Zimbabwe Clinical Research Centre (UZCRC)

Collaborator