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| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
| Armauer Hansen Research Institute, Ethiopia | OTHER |
| Adama Hospital Medical College, Ethiopia | UNKNOWN |
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The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC).
Specific aims are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- Triage arm for HPV pos women | Active Comparator | HPV positive women |
|
| 2- Triage arm for HPV pos women | Experimental | HPV positive women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) | Diagnostic Test | A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of VIA and VIA/VILI as triage test | All HPV pos women will have a cervical biopsy taken | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of STI other than HPV | Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis | 8 weeks |
| Vaginal Microbiota composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selamawit Mekuria, MD | Contact | +46720123974 | selamawit.mekuria@med.lu.se | |
| Mats Jerkeman, MD, PhD | Contact | +46704973507 | mats.jerkeman@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Adane Mihret, PhD | Armauer Hansen Research Institute, Ethiopia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adama and Geda Health Center | Recruiting | Ādama | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40877387 | Derived | Mekuria S, Assiged N, Biazin H, Borgfeldt C, Abebe T, Mihret A, Forslund O, Jerkeman M. Assessing the feasibility of HPV screening for cervical cancer in pregnant women in Ethiopia. Sci Rep. 2025 Aug 28;15(1):31771. doi: 10.1038/s41598-025-15957-y. | |
| 39362749 | Derived | Mekuria SF, Biazin H, Abebe T, Borgfeldt C, Assegid N, Mihret A, Obsi Nemomsa R, Forslund O, Jerkeman M. Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial. Int J Gynecol Cancer. 2024 Nov 4;34(11):1691-1697. doi: 10.1136/ijgc-2024-005694. |
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The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.
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| VIA (Visual Inspection with Acetic acid) | Diagnostic Test | A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix. |
|
Assessed in HPV high risk pos women at initiation, who persist and who clear their infection
| 24 months |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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