Clinical trial NCT05133661: SUCCESS - Feasibility of HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions (HPV Study)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: HPV Screening
Precancerous lesions
Thermal ablation
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: UNITAID
name: Expertise France
name: World Health Organization
First posted: 2021-11-24
Enrollment: 17602
Sex: ALL
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Women: Participants will be drawn from women seeking care at the SUCCESS project supported sites. For the general population, women aged 30-49 years will be enrolled while for HIV+ women, those aged 25-49 years will be enrolled. Women who do not know their HIV status at enrolment will have an opportunity to be tested.
* Key informants will be identified from among the stakeholder holding positions that allows them to provide information that is relevant to the assessment of acceptability, feasibility, and costs related to implementation of cervical cancer prevention and treatment services in the four countries. from seeking care in health facilities in the four countries.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of HPV positive women who complete screen to treatment within 3 months
timeFrame: Three months
Secondary outcomes:
measure: Acceptability - Percentage of women screened for HPV who report positive experience of care
timeFrame: 18 months
measure: Feasibility - Turnaround time from screening to treatment
timeFrame: 18 months
measure: Unit cost of providing HPV screening and treatment of precancerous cervical cancer lesion
timeFrame: 18 months
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: CMA de Do
city: Bouaké
country: Côte D'Ivoire
facility: FSU Koko
city: Quetzaltenango
country: Guatemala
facility: Quetzaltenango
city: Quezon City
country: Philippines
facility: Metro-Manila
Study officials:
References: