{
"info": {
"nct_id": "NCT06577220",
"official_title": "A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System Asian/Asian American Women",
"inclusion_criteria": "* Asian ethnicity reported in the electronic health record\n* no history of hysterectomy or cervical cancer\n* no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years\n* patient of Harris Health System in Harris County (Houston), Texas\n* have at least 2 visits to ambulatory care within Harris Health System in the past 5 years\n* be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 30 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* no valid telephone contact information\n* unable to communicate in English, Vietnamese or Spanish\n* currently pregnant\n* history of cervical dysplasia in the past 3.5 years",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Asian ethnicity reported in the electronic health record",
"criterions": [
{
"exact_snippets": "Asian ethnicity reported in the electronic health record",
"criterion": "ethnicity",
"requirements": [
{
"requirement_type": "reported",
"expected_value": "Asian"
}
]
}
]
},
{
"line": "* no history of hysterectomy or cervical cancer",
"criterions": [
{
"exact_snippets": "no history of hysterectomy",
"criterion": "hysterectomy",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "no history of ... cervical cancer",
"criterion": "cervical cancer",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years",
"criterions": [
{
"exact_snippets": "no Pap test in the past 3.5 years",
"criterion": "Pap test",
"requirements": [
{
"requirement_type": "time since last test",
"expected_value": {
"operator": ">",
"value": 3.5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "Pap/HPV co-test in the past 5.5 years",
"criterion": "Pap/HPV co-test",
"requirements": [
{
"requirement_type": "time since last test",
"expected_value": {
"operator": "<=",
"value": 5.5,
"unit": "years"
}
}
]
}
]
},
{
"line": "* patient of Harris Health System in Harris County (Houston), Texas",
"criterions": [
{
"exact_snippets": "patient of Harris Health System",
"criterion": "Harris Health System patient",
"requirements": [
{
"requirement_type": "membership",
"expected_value": true
}
]
},
{
"exact_snippets": "Harris County (Houston), Texas",
"criterion": "location",
"requirements": [
{
"requirement_type": "residence",
"expected_value": "Harris County (Houston), Texas"
}
]
}
]
},
{
"line": "* have at least 2 visits to ambulatory care within Harris Health System in the past 5 years",
"criterions": [
{
"exact_snippets": "at least 2 visits to ambulatory care within Harris Health System in the past 5 years",
"criterion": "ambulatory care visits",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "visits"
}
},
{
"requirement_type": "location",
"expected_value": "Harris Health System"
},
{
"requirement_type": "time frame",
"expected_value": "past 5 years"
}
]
}
]
},
{
"line": "* be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months",
"criterions": [
{
"exact_snippets": "currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System",
"criterion": "current healthcare coverage or financial assistance plan",
"requirements": [
{
"requirement_type": "acceptance by Harris Health System",
"expected_value": true
}
]
},
{
"exact_snippets": "have been enrolled in a Harris Health coverage plan in the past 12 months",
"criterion": "past enrollment in Harris Health coverage plan",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
]
}
]
},
{
"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 65 Years",
"criterions": [
{
"exact_snippets": "maximum age of 65 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 65,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* no valid telephone contact information",
"criterions": [
{
"exact_snippets": "no valid telephone contact information",
"criterion": "telephone contact information",
"requirements": [
{
"requirement_type": "validity",
"expected_value": true
}
]
}
]
},
{
"line": "* unable to communicate in English, Vietnamese or Spanish",
"criterions": [
{
"exact_snippets": "unable to communicate in English, Vietnamese or Spanish",
"criterion": "language communication ability",
"requirements": [
{
"requirement_type": "languages",
"expected_value": [
"English",
"Vietnamese",
"Spanish"
]
},
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* currently pregnant",
"criterions": [
{
"exact_snippets": "currently pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "pregnant"
}
]
}
]
},
{
"line": "* history of cervical dysplasia in the past 3.5 years",
"criterions": [
{
"exact_snippets": "history of cervical dysplasia in the past 3.5 years",
"criterion": "cervical dysplasia",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3.5,
"unit": "years"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}