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

NCT05133661 | Active Not Recruiting

• 2 other identifiers: ERC0003618IRB13630
• Study Type: observational
• Target: 17,602
• Locations: 4 countries
• Sites: 4

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.

Conditions

Cervical Cancer

Keywords

HPV Screening; Precancerous lesions; Thermal ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acceptability - Percentage of women screened for HPV who report positive experience of care

  18 months

• Feasibility - Turnaround time from screening to treatment

  18 months

• Unit cost of providing HPV screening and treatment of precancerous cervical cancer lesion

  18 months

Study Arms (1)

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.

Diagnostic Test: HPV testing

Interventions

HPV testing DIAGNOSTIC_TEST

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.

Also known as: Thermal ablation of precancerous lesion

HPV positive women

Eligibility Criteria

• Age: 25 Years - 49 Years
• Gender Eligibility Details: Women screened for HPV
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• Individuals unwilling to participate or unable to provide informed consent

Sponsors & Collaborators

• Jhpiego: lead
• UNITAID: collaborator
• Expertise France: collaborator
• World Health Organization: collaborator

Study Sites (4)

CMA de Do

Ouagadougou, Burkina Faso

Location

FSU Koko

Bouaké, Côte d’Ivoire

Location

Quetzaltenango

Quetzaltenango, Guatemala

Location

Metro-Manila

Quezon City, Philippines, 1103, Philippines

Location

Related Publications (1)

• Kabue M, Gauvreau CL, Daceney N, Bertram MM, Shissler T, Reis V, Dodo M, Garces A, Llave C, Dao B, Mohan D, Huang L. Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d'Ivoire, Guatemala and Philippines: study protocol. Reprod Health. 2023 Nov 13;20(1):167. doi: 10.1186/s12978-023-01696-8.

  PMID: 37957689 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Monitoring Evaluation and Research Advisor

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 24, 2021
• Study Start: April 19, 2022
• Primary Completion: September 5, 2025
• Study Completion: December 31, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

GU (1); BU (1); CÔ (1); PH (1)