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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorFred Hutchinson Cancer Center

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. 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.

Eligibility criteria

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Thermal ablation (TA) with 1 probe

    Procedure/Surgery

    Undergo TA with 1 probe

  • Thermal ablation (TA) with 2 probes

    Procedure/Surgery

    Undergo TA with 2 probes

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Group 1 (TA with 1 probe)Experimental treatment 1 intervention
Group B: Group 2 (TA with 2 probes)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with persistent HPV at 6 months

hrHPV positive at 0 and 6 months

Time frame
From enrollment to follow up at 6 months

Secondary outcomes

Other outcomes

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

University of Rwanda

Collaborator

Frontier Science & Technology Research Foundation, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: