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| Name | Class |
|---|---|
| Merck Canada Inc. | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination starting from visit 1 | Experimental | Vaccination will be provided at the first visit and then at 6 months for HPV negative women and 12 months for HPV positive women. |
|
| Vaccination starting at follow up | Experimental | Vaccination will be provided after HPV results obtained - immediately for HPV negative women and again after 3 months. For HPV positive women this will be offered at 12 months after testing and again at 15 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination Provision | Biological | HPV vaccination #1 will be offered by provider at the first visit when the HPV self-sample is collected. HPV Vaccination #2 will be offered at 6 months for HPV negative women and at 12 months for HPV positive women. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence Generation for use of a 4-step HPV testing, triage and vaccinate strategy | The primary endpoint will be a composite of HSIL on cervical histology at 12 months re-screening (follow-up). Secondary endpoints will include CIN3 on cervical histology, and grade 3 or 4 adverse events related to vaccination. Additional secondary endpoints will include participant-level predictors that may act as moderators of participation in cervical cancer screening and/or HPV vaccination. The investigators will also collect qualitative and quantitative data on the feasibility, impact, and cost-effectiveness of the different screening strategies through key informant interviews and focus groups comprised on clinic leadership, health providers and study participants. | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
Women that do not want to receive the vaccine will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Yeates, MD,MPH | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamoja Tunaweza Women's Centre | Moshi | Tanzania |
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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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| Vaccination Provision 2 | Biological | HPV vaccination #1 will be offered by the provider after an HPV negative result is received with vaccine #2 given at 3 months after negative test results obtained. For HPV positive women - vaccination #1 will be offered at 12 months and vaccination #2 will be offered at the 15 month mark. |
|
| 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 |