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NCT07645352Recruiting

Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe

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. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment 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 and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
9 Jun 2026
Start date
15 Oct 2026
Primary completion date
31 Dec 2027
Lead sponsor
Fred Hutchinson Cancer Center
NCT number
NCT07645352

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Zimbabwe, Centre for Research
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HarareZimbabweRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.