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Comparing one or two heat probes to treat cervical precancer in women with HIV

Tests one versus two heat probes for cervical precancer in women living with HIV.

Plain-language title generated from the registry record
Registry title: Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda

Key facts

Where
Kigali, RwandaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 25-49 who live with HIV and had a positive cervical screening test. It compares thermal ablation with one probe versus two probes.

Age
25-49 years
Sex
Women only
Disease stage
Positive hrHPV or VIA test within 3 months of enrollment; type 1 transformation zone (TZ1); able to have thermal ablation.
Earlier treatment
No past treatment for cervical precancer. Not currently treated for any cancer.
Biomarker or test result
Positive hrHPV or VIA test within 3 months of enrollment. Living with HIV.

Main reasons for not taking part

  • Screened for cervical cancer outside the study in the last 6 months
  • Currently pregnant or less than 6 weeks after giving birth
  • Past diagnosis of cervical cancer
  • Total hysterectomy
  • Currently receiving treatment for any cancer

This trial only enrols participants living with HIV. The registry sentence this rests on: Living with HIV

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 25 and 49 years old?

Source: NCT07390916, who can take part

Where in Rwanda

  • Research for Development (RD) RwandaKigali, RwandaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Fred Hutchinson Cancer Center
Trial code
NCT07390916
Record updated
3 November 2026
Original description
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.Read full original descriptionShow less

Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV

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.

Inclusion: 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.

Exclusion: Prior diagnosis of cervical cancer; Currently receiving treatment for any cancer; 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; Currently pregnant or less than 6 weeks postpartum; Total hysterectomy.

ClinicalTrials.gov NCT07390916