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
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
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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
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