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

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. 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.

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

Emory University

Collaborator

Coptic Hope Center

Collaborator