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

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 interventional feasibility study compares endocervical plus ectocervical two-probe thermal ablation to standard single-probe treatment in HIV-positive women with type 1 transformation zones who are eligible for ablation. Participants screen-positive for cervical precancer receive randomization to 1-probe or 2-probe TA and are followed for 6 months with HPV testing, cervical sampling, and visual assessment to evaluate safety, acceptability, and feasibility. The study aims to determine if the two-probe approach improves treatment outcomes and aligns with WHO goals for cervical cancer elimination in high-burden settings. Eligible sites include South Africa, with collaboration among Fred Hutch, University of Washington, NCI, and University of Cincinnati.

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

• Centre for the AIDS Programme of Research in South Africa
  Durban, South Africa 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 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

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

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  Recruiting Fred Hutchinson Cancer Center · Kigali · NCT07390916

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• 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.