NCT07390916Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 29 Jan 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fred Hutchinson Cancer Center
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT07390916
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 15 Oct 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of cervical cancer
- Currently receiving treatment for any cancer
Other illness
- Screened for cervical cancer outside of study in last 6 months
- A history of treatment for cervical precancer
- Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
- Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled
Other
- Currently pregnant or less than 6 weeks postpartum
- Total hysterectomy
Who the study is looking for
- 25-49 years old
- Living with HIV
- Intact cervix
- Willing to return to facility at 6 months
- Willing and able to provide informed consent
- Positive hrHPV or VIA test within 3 months of enrollment
- Type 1 transformation zone (TZ1)
- Thermal ablation eligible
Age in the registry: 25 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research for Development (RD) Rwanda Coordinator of this site? Confirm its status | Kigali | Rwanda | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.