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O estudo clínico NCT05133661 (HPV) para Câncer cervical está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
SUCCESS - Feasibility of HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions (HPV Study)
- How feasible is it to implement integrated HPV testing (including self-collection of samples) and ablative treatment of lesions precancerous cervical cancer lesions among HPV+ women aged 30-49 years (general population) and 25-49 years (WLHIV), leveraging on the existing health systems in the four study countries?
- What is the acceptability of HPV screening through self-collection or clinician collection of sample, and ablative treatment of precancerous lesions among women accessing cervical cancer services in the study sites?
- What is the cost of implementing integrated cervical cancer screening and precancer treatment services (Supply: counselling, HPV testing, treatment, training health care providers, etc.), and user-related costs (travel, out of pocket expenses opportunity costs, etc.) in the SUCCESS project supported sites?
- Which factors influence the successful implementation of integrated HPV screening and treatment services (e.g. perceptions, experience of care, religious beliefs, culture, individual characteristics, availability of services, cost, etc.)?
Methodology:
We will utilize a hybrid effectiveness implementation Type III study design, using mixed methods approach. In Phase I, 2,227 women are enrolled in health facilities in each of the four countries (disaggregated by general population and WLHIV) and follow those who are HPV positive to determine the completion of screen-to-treat within three months. In Phase II focusing on community self-sampling, 8,694 are enrolled in Burkina Faso, Guatemala and the Philippines.
Quantitative and qualitative data will be collected from clients, service providers, key stakeholders, and secondary analysis of service delivery including laboratory data will be analyzed to assess acceptability and feasibility of implementing integrated cervical cancer screening and treatment services.
Feasibility and Acceptability of Implementing Integrated HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions in Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines
- HPV
- ERC0003618
- IRB13630 (Outro identificador) (Johns Hopkins Bloomberg School of Public Health IRB)
Precancerous lesions
Thermal ablation
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
HPV positive women Women aged 25-49 years seeking offered HPV testing (either self-collection or clinician collection of samples) and treatment of precancerous lesions as part of service package in study facilities will be enrolled in the study and interviewed at different time points.
A subset of the women screened will be selected for in-depth interview to gather data on: ease of use of self-collection kits for cervical cancer screening, receipt of the test results, and treatment for precancer. Another subset of women will be selected after HPV screening to participate in client exit interview. | Teste de HPV Interviews will be conducted among women from the general population and HIV+ women after screening for HPV. A small subset of participants will be interviewed after receiving treatment for precancer. HPV test results and outcome of the precancer treatment if indicated will be documented. |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Percentage of HPV positive women who complete screen to treatment within 3 months | Proportion of HPV positive women who undergo treatment for precancerous cervical lesions within three months of screening | Three months |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Acceptability - Percentage of women screened for HPV who report positive experience of care | Assess the adoption, satisfaction, and uptake of the cervical cancer services by the users and the providers | 18 months |
Feasibility - Turnaround time from screening to treatment | Assess the adoption and practicability of providing the cervical cancer services through the mechanisms that exist in of each of the four countries | 18 months |
Unit cost of providing HPV screening and treatment of precancerous cervical cancer lesion | The cost of providing the services and the user costs | 18 months |
- Women: Participants will be women residing in the study area, seeking services at SUCCESS project-supported health facilities, and meet the eligibility criteria to be enrolled in one of the components of the study (i.e, prospective component, client exit interviews and/or in-depth interviews).
- Service providers: Health care personnel working in the project facilities at the time of the study providing services related to cervical cancer screening and treatment. Facility in-charges and laboratory personnel are included in this category.
- Key informants: Health program managers, and community mobilizers at either local or national level in Burkina Faso, Cote d'Ivoire, Guatemala, and Philippines.
- Men: Male members of the community (married or cohabiting with female partners) to gather their perspectives on the implementation of the cervical cancer prevention and treatment activities.
- Pregnant women
- Individuals unwilling to participate or unable to provide informed consent
- 🏛️UNITAID
- 🏛️Expertise France
- ⚕️World Health Organization
Philippines