HIV (Human Immunodeficiency Virus)NCT07468695
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
A study testing Thermal ablation (TA) with 1 probe and Thermal ablation (TA) with 2 probes in people with HIV (Human Immunodeficiency Virus) and HPV, run by Fred Hutchinson Cancer Center at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), HPV, Cervical Precancer
- What is being tested?
- Thermal ablation (TA) with 1 probe and Thermal ablation (TA) with 2 probes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteKenya
- Study dates
- 12 Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Total hysterectomy
- Currently receiving treatment for any cancer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Coptic Hope Center
Nairobi
Samah R Sakr, MBChB, MRCS
Michael H Chung, MD, PhD, MPH, FRCP
About this study
Official title: 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. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among WLWH.
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.
Read the detailed description
Participants will first undergo HPV testing or visual inspection with acetic acid at screening. Participants with positive screening results undergo a clinical exam comprising visual inspection with acetic acid, digital imaging, brush biopsies of the ectocervix and the endocervix, and assessment for TA treatment. Participants who have a type 1 transformation zone (TZ1) and are otherwise eligible for TA will receive TA with either one or two probes. Screen positive women will be randomized to:
GROUP 1: TA with 1 probe. GROUP 2: TA with 2 probes.
Participants are followed up at 6 months with an HPV test, brush biopsies, and visual assessment of the cervix.
Participants who are not TA eligible will be referred to local care.
- Conditions
- HIV (Human Immunodeficiency Virus), HPV, Cervical Precancer
- Being tested
- Thermal ablation (TA) with 1 probe, Thermal ablation (TA) with 2 probes
- Keywords
- HIV, Cervical cancer screening, Treatment of Cervical Precancer, Thermal ablation, Human papillomavirus
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablation (TA) with 1 probeProcedure or surgery
Undergo TA with 1 probe
Thermal ablation (TA) with 2 probesProcedure or surgery
Undergo TA with 2 probes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TA with 1 probe) | Experimental | Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 1 probe at month 0. Receives: Procedure: Thermal ablation (TA) with 1 probe |
| Group 2 (TA with 2 probes) | Experimental | Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 2 probes at month 0. Receives: Procedure: Thermal ablation (TA) with 2 probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV positive
Proportion of participants with persistent HPV at 6 months
Measured: From enrollment to follow up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start12 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Cancer Institute (NCI), University of Cincinnati, Frontier Science & Technology Research Foundation, Inc., Emory University, Coptic Hope Center
- Responsible party
- Principal investigator, Margaret M. Madeleine, PhD, Fred Hutchinson Cancer Center
- Investigators
- Rachel L Winer, PhD, MPH, Principal investigator, University of WashingtonMargaret M Madeleine, PhD, MPH, Study chair, Fred Hutchinson Cancer CenterLeeya Pinder, MD, MPH, Study chair, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468695
- Sponsor's protocol ID
- RG1124082 (C1001P-CS2 Kenya)
- Other IDs
- UG1CA275402, U24CA275417, UG1CA275400
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data will be shared in a timely manner, with appropriate privacy and confidentiality protections, using the policies and procedures outlined in the NIH Guidelines for Sharing Research Data. Guidelines, oversight, and requirements for sharing data are based on the institutional policies, IRB rules, and local, state, and federal laws and regulations. In all cases, the privacy and confidentiality of all people who participate in the research will be protected. Clinical data on women living with HIV generated during the study will be made available to researchers in both the private and public sector free or for a nominal charge.