Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda

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 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. Rwanda hopes to achieve this goal early, in 2027 under Mission 2027.

Sex

Female

Minimum age

25 Years

Maximum age

49 Years

Inclusion Criteria:

1. 25-49 years old
2. Living with HIV

Inclusion criteria specific to the feasibility study

1. Intact cervix
2. Willing to return to facility at 6 months
3. Willing and able to provide informed consent
4. Positive hrHPV or VIA test within 3 months of enrollment
5. Type 1 transformation zone (TZ1)
6. Thermal ablation eligible

Exclusion Criteria:

1. Screened for cervical cancer outside of study in last 6 months
2. Currently pregnant or less than 6 weeks postpartum
3. Prior diagnosis of cervical cancer
4. A history of treatment for cervical precancer
5. Total hysterectomy
6. Currently receiving treatment for any cancer
7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled