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

Cervical Cancer Clinical Trial

— HPV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133661
• Other study ID #: ERC0003618
• Secondary ID: IRB13630
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Jhpiego
• Contact: MARK M KABUE, Dr.PH
• Phone: (1)4433266518
• Email: Mark.Kabue[@]jhpiego.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. We will screen 2227 women in each country (disaggregated by general population and WLHIV) and follow those who are HPV positive to determine the completion of screen-to-treat within three months.

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 in the four countries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8908
• Est. completion date: June 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant women

• Individuals unwilling to participate or unable to provide informed consent

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	CMA de Do	Ouagadougou
Côte D'Ivoire	FSU Koko	Bouaké

Sponsors (4)

Lead Sponsor	Collaborator
Jhpiego	Expertise France, UNITAID, World Health Organization

Countries where clinical trial is conducted

Burkina Faso,  Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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