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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Thermal ablation (TA) with 1 probe
Procedure/SurgeryUndergo TA with 1 probe
Thermal ablation (TA) with 2 probes
Procedure/SurgeryUndergo TA with 2 probes
Treatment groups
Trial outcomes
Primary outcomes
Proportion of participants with persistent HPV at 6 months
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options: