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. 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
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
Centre for the AIDS Programme of Research in South Africa
Collaborator