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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Araceli Loera, MPH
- Numéro de téléphone: +1 206-667-5816
- E-mail: aloera@fredhutch.org
Lieux d'étude
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Durban, Afrique du Sud
- Recrutement
- Centre for the AIDS Programme of Research in South Africa
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Contact:
- Nivashnee Naicker, MBChB, MAS, MPH
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Test of Cure
Délai: From enrollment to follow up at 6 months
|
Proportion of participants with persistent HPV positive test at 6 months |
From enrollment to follow up at 6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rachel L Winer, PhD, MPH, University of Washington
- Chaise d'étude: Margaret M Madeleine, PhD, MPH, Fred Hutchinson Cancer Center
- Chaise d'étude: Leeya Pinder, MD, MPH, University of Cincinnati
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Maladies urogénitales
- Maladies génitales
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies du système immunitaire
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies utérines
- Maladies génitales, femme
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies à virus lents
- Conditions précancéreuses
- Maladies du col de l'utérus
- Infections à VIH
- Syndrome immunodéficitaire acquis
- Dysplasie cervicale utérine
Autres numéros d'identification d'étude
- RG1124082 (C1001P-CS9 So Af)
- UG1CA275402 (Subvention/contrat des NIH des États-Unis)
- U24CA275417 (Subvention/contrat des NIH des États-Unis)
- 5UG1CA284671-03 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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