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Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV
- Sponsor
- Fred Hutchinson Cancer Center (Academic or other)
- Enrolment
- 300 planned
- Conditions
- HIV (Human Immunodeficiency Virus); HPV; Cervical Precancer
- Interventions
- Thermal ablation (TA) with 1 probe; Thermal ablation (TA) with 2 probes
- Ages
- adults
- Registry
- NCT07390916
From the registry
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. This is even more important at a time when Rwanda has launched a National Cervical Cancer Screening Program (NCCSP) with human papillomavirus (HPV) testing and treatment, mainly using TA with unknown outcomes. Therefore, we will conduct a feasibility study (C1001P-CS5) among 300 Rwandan WLWH to provide evidence needed to launch a future 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…
Primary outcomes
- Proportion of participants with persistent HPV at 6 months