Two-probe thermal ablation for cervical precancer in WLWH in Rwanda

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility study enrolling 300 women living with HIV in Rwanda who have positive cervical cancer screening results and a type 1 transformation zone. Participants are randomized to receive thermal ablation with either one probe (ectocervical) or two probes (endocervical and ectocervical). Follow-up at 6 months includes HPV testing, cervical biopsies, and visual assessment to evaluate safety, feasibility, and preliminary outcomes. The study aims to inform a future effectiveness trial within the national screening program. Women not eligible for thermal ablation are referred to standard care at local facilities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 25-49 years old
2. Living with HIV

Inclusion criteria specific to the feasibility study

1. Intact cervix
2. Willing to return to facility at 6 months
3. Willing and able to provide informed consent
4. Positive hrHPV or VIA test within 3 months of enrollment
5. Type 1 transformation zone (TZ1)
6. Thermal ablation eligible

Exclusion Criteria:

1. Screened for cervical cancer outside of study in last 6 months
2. Currently pregnant or less than 6 weeks postpartum
3. Prior diagnosis of cervical cancer
4. A history of treatment for cervical precancer
5. Total hysterectomy
6. Currently receiving treatment for any cancer
7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled

Where it's running

• Research for Development (RD) Rwanda
  Kigali, Rwanda Recruiting

Study contacts

• Principal investigator: Rachel L Winer, PhD, MPH — University of Washington
• Study coordinator: Araceli Loera, MPH
• Email: aloera@fredhutch.org
• Phone: +1 206-667-5816

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Two-probe thermal ablation for cervical precancer in WLWH in South Africa

  This study tests whether using two probes for thermal ablation is safer or more effective than one probe for treating cervical precancer in women living with HIV in South Africa.

  Recruiting Fred Hutchinson Cancer Center · Durban · NCT07645378

• Two-probe thermal ablation for cervical precancer in WLWH in Zimbabwe

  This study tests whether using two TA probes (endocervical and ectocervical) is better than one probe for treating cervical precancer in women living with HIV in Zimbabwe.

  Recruiting Fred Hutchinson Cancer Center · Harare · NCT07645352

• Two-probe thermal ablation for cervical precancer in HIV+ women in Kenya

  This study tests whether using two probes for thermal ablation is more effective and acceptable than one probe for treating cervical precancer in women living with HIV in Kenya.

  Recruiting Fred Hutchinson Cancer Center · Nairobi · NCT07468695

• Pregnant Women Living with HIV on Bictegravir/Emtricitabine/Tenofovir Alafenamide

  This study looks at how B/F/TAF is used in pregnant women with HIV and whether it helps maintain viral suppression from before conception through delivery.

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• Multiple interventions to try for HIV remission in people on ART

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  Recruiting Phase 2 Federal University of São Paulo · São Paulo, São Paulo · NCT07903441

• Can people collect their own vaginal sample for HPV testing as well as clinician collection for comparison?

  This study tests whether individuals can correctly use a self-collection device to gather a vaginal sample for high-risk HPV screening and whether the self-collected sample agrees with clinician-collected samples.

  Recruiting at 11 sites Mel Mont Medical · Phoenix, Arizona and 10 other locations · NCT07758140

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.