{
    "info": {
        "nct_id": "NCT01824537",
        "official_title": "Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study: A Randomized Controlled Trial of the Efficacy of HPV Vaccination in Preventing Transmission of HPV Infection in Heterosexual Couples",
        "inclusion_criteria": "* Couple must have been in a new relationship that started no more than six months prior to study entry\n* Both partners plan on remaining in Montreal for at least 1 year\n* Plan on having continued sexual contact with partner\n* Be willing to comply with study procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 45 Years",
        "exclusion_criteria": "* Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners)\n* Any history of cervical, penile, oral or anal cancers\n* Being pregnant or plan on immediately becoming pregnant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Couple must have been in a new relationship that started no more than six months prior to study entry",
            "criterions": [
                {
                    "exact_snippets": [
                        "Couple must have been in a new relationship"
                    ],
                    "criterion": "relationship status",
                    "requirement_type": "type",
                    "expected_value": "new"
                },
                {
                    "exact_snippets": [
                        "relationship that started no more than six months prior to study entry"
                    ],
                    "criterion": "relationship duration",
                    "requirement_type": "maximum duration",
                    "expected_value": {
                        "operator": "<=",
                        "value": 6
                    }
                }
            ]
        },
        {
            "line": "* Both partners plan on remaining in Montreal for at least 1 year",
            "criterions": [
                {
                    "exact_snippets": [
                        "Both partners plan on remaining in Montreal"
                    ],
                    "criterion": "residence location",
                    "requirement_type": "location",
                    "expected_value": "Montreal"
                },
                {
                    "exact_snippets": [
                        "at least 1 year"
                    ],
                    "criterion": "residence duration",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Plan on having continued sexual contact with partner",
            "criterions": [
                {
                    "exact_snippets": [
                        "continued sexual contact with partner"
                    ],
                    "criterion": "sexual contact with partner",
                    "requirement_type": "intention",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Be willing to comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": [
                        "Be willing to comply with study procedures"
                    ],
                    "criterion": "willingness to comply",
                    "requirement_type": "N/A",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 45 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 45 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 45
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Volunteers must not have been vaccinated against HPV-Gardasil-9"
                    ],
                    "criterion": "HPV-Gardasil-9 vaccination",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "both partners"
                    ],
                    "criterion": "partners",
                    "requirement_type": "number",
                    "expected_value": ">= 2"
                }
            ]
        },
        {
            "line": "* Being pregnant or plan on immediately becoming pregnant",
            "criterions": [
                {
                    "exact_snippets": [
                        "Being pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "plan on immediately becoming pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "intention",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Any history of cervical, penile, oral or anal cancers",
            "criterions": [
                {
                    "exact_snippets": [
                        "history of cervical"
                    ],
                    "criterion": "cervical cancer",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of penile"
                    ],
                    "criterion": "penile cancer",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of oral"
                    ],
                    "criterion": "oral cancer",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of anal"
                    ],
                    "criterion": "anal cancer",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}