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| ID | Type | Description | Link |
|---|---|---|---|
| IRB13630 | Other Identifier | Johns Hopkins Bloomberg School of Public Health IRB |
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| Name | Class |
|---|---|
| UNITAID | OTHER |
| Expertise France | OTHER |
| World Health Organization | OTHER |
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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.
Research question:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women screened for HPV
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMA de Do | Ouagadougou | Burkina Faso | ||||
| FSU Koko |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37957689 | Derived | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| Bouaké |
| Côte d’Ivoire |
| Quetzaltenango | Quetzaltenango | Guatemala |
| Metro-Manila | Quezon City | Philippines | 1103 | Philippines |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |