{
"info": {
"nct_id": "NCT06166420",
"official_title": "Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial",
"inclusion_criteria": "* Women aged 30-49 years\n* Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).\n\nNon-inclusion criteria:\n\n* Pregnancy at the time of screening\n* History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).\n* Intra-vaginal treatment\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 30 Years\nMust have maximum age of 49 Years",
"exclusion_criteria": "* Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)\n* Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)\n* Women who are not able to comply with the study protocol.\n* Previous hysterectomy\n* Known cervical cancer",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Women aged 30-49 years",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "aged 30-49 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 30,
"unit": "years"
},
{
"operator": "<=",
"value": 49,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).",
"criterions": [
{
"exact_snippets": "Ability to understand study procedures",
"criterion": "understanding of study procedures",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "accepting voluntarily to participate by signing an informed consent form (ICF)",
"criterion": "voluntary participation",
"requirements": [
{
"requirement_type": "action",
"expected_value": "signing an informed consent form (ICF)"
}
]
}
]
},
{
"line": "* Pregnancy at the time of screening",
"criterions": [
{
"exact_snippets": "Pregnancy at the time of screening",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Intra-vaginal treatment",
"criterions": [
{
"exact_snippets": "Intra-vaginal treatment",
"criterion": "intra-vaginal treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "Must have minimum age of 30 Years",
"criterions": [
{
"exact_snippets": "minimum age of 30 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 49 Years",
"criterions": [
{
"exact_snippets": "maximum age of 49 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 49,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)",
"criterions": [
{
"exact_snippets": "Symptoms of cervical cancer (e.g. metrorrhagia",
"criterion": "metrorrhagia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Symptoms of cervical cancer ... known pelvic mass",
"criterion": "pelvic mass",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)",
"criterions": [
{
"exact_snippets": "Severe pre-existing medical conditions",
"criterion": "pre-existing medical conditions",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "advanced cancer",
"criterion": "cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
}
]
},
{
"exact_snippets": "terminal renal failure",
"criterion": "renal failure",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "terminal"
}
]
}
]
},
{
"line": "* Women who are not able to comply with the study protocol.",
"criterions": [
{
"exact_snippets": "Women who are not able to comply with the study protocol.",
"criterion": "ability to comply with the study protocol",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* Previous hysterectomy",
"criterions": [
{
"exact_snippets": "Previous hysterectomy",
"criterion": "hysterectomy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Known cervical cancer",
"criterions": [
{
"exact_snippets": "Known cervical cancer",
"criterion": "cervical cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "Non-inclusion criteria:",
"criterions": []
},
{
"line": "* History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).",
"criterions": [
{
"exact_snippets": "History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women)",
"criterion": "cervical cancer screening by HPV test",
"requirements": [
{
"requirement_type": "history",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 5,
"unit": "years"
}
]
}
},
{
"requirement_type": "HIV status",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "History of cervical cancer screening by HPV test of less than 3 years (for HIV positive women)",
"criterion": "cervical cancer screening by HPV test",
"requirements": [
{
"requirement_type": "history",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 3,
"unit": "years"
}
]
}
},
{
"requirement_type": "HIV status",
"expected_value": "positive"
}
]
}
]
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}