Cervical Neoplasia, Cervical Precancer, HIV (Human Immunodeficiency Virus), HPV
Conditions
Keywords
HIV, Cervical cancer screening, Treatment of Cervical Precancer, Thermal ablation, Human papillomavirus
Brief 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. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in 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.
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.
Interventions
PROCEDUREThermal ablation (TA) with 1 probe
Undergo TA with 1 probe
PROCEDUREThermal ablation (TA) with 2 probes
Undergo TA with 2 probes
Sponsors
Fred Hutchinson Cancer Center
University of Washington
National Cancer Institute (NCI)
University of Cincinnati
Frontier Science & Technology Research Foundation, Inc.
Centre for the AIDS Programme of Research in South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Clinical Site staff involved in provision of clinical care, recruitment, or follow-up will be blinded to allocation until after visual inspection.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with persistent HPV at 6 months | From enrollment to follow up at 6 months |
Countries
South Africa
Contacts
CONTACTAraceli Loera, MPH
PRINCIPAL_INVESTIGATORRachel L Winer, PhD, MPH
University of Washington
STUDY_CHAIRMargaret M Madeleine, PhD, MPH
Fred Hutchinson Cancer Center
STUDY_CHAIRLeeya Pinder, MD, MPH
University of Cincinnati
Outcome results
None listed