Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
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. 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Araceli Loera, MPH
- Número de teléfono: +1 206-667-5816
- Correo electrónico: aloera@fredhutch.org
Ubicaciones de estudio
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Durban, Sudáfrica
- Reclutamiento
- Centre for the AIDS Programme of Research in South Africa
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Contacto:
- Nivashnee Naicker, MBChB, MAS, MPH
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 25-49 years old
- Living with HIV
Inclusion criteria specific to the feasibility study
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1 (TA with 1 probe)
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. |
Undergo TA with 1 probe |
|
Experimental: Group 2 (TA with 2 probes)
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. |
Undergo TA with 2 probes |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Test of Cure
Periodo de tiempo: From enrollment to follow up at 6 months
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Proportion of participants with persistent HPV positive test at 6 months |
From enrollment to follow up at 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rachel L Winer, PhD, MPH, University of Washington
- Silla de estudio: Margaret M Madeleine, PhD, MPH, Fred Hutchinson Cancer Center
- Silla de estudio: Leeya Pinder, MD, MPH, University of Cincinnati
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades de virus lentos
- Condiciones precancerosas
- Enfermedades del cuello uterino
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
- Displasia Cervical Uterina
Otros números de identificación del estudio
- RG1124082 (C1001P-CS9 So Af)
- UG1CA275402 (Subvención/contrato del NIH de EE. UU.)
- U24CA275417 (Subvención/contrato del NIH de EE. UU.)
- 5UG1CA284671-03 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Deidentified data, the study protocol, and the data dictionary will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes, for up to 5 years.
Criterios de acceso compartido de IPD
Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by the Biomedical Research Ethics Committee (BREC) or Fred Hutch regulatory review committees or NCI.
Información sobre medicamentos y dispositivos, documentos del estudio
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