NCT05133661

SUCCESS - Feasibility of HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions (HPV Study)

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 17,602 (estimated)
• Sponsor: Jhpiego · Academic / Other
• Sex: All
• Age: 25 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The goal is to assess the feasibility and acceptability of integrating into existing health systems, provision of HPV screening and treatment of pre-cancerous cervical cancer lesions with ablative treatments in Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines. Study findings will inform implementation of cervical cancer prevention and treatment services as part of a global effort to eliminate cervical cancer, with particular relevance for low-and-middle income countries. This will inform country strategy and guidelines on offering integrated cervical cancer prevention and treatment services in a manner that is culturally sensitive, client oriented, and system appropriate.

Detailed description

Research question: 1. 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? 2. 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? 3. 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? 4. 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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV testing	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.

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-09-05
• Completion: 2025-12-31
• First posted: 2021-11-24
• Last updated: 2025-09-17

Locations

4 sites across 4 countries: Burkina Faso, Côte d’Ivoire, Guatemala, Philippines