Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-30 @ 12:24 AM
Study NCT ID:
NCT03984695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sexual Health Empowerment for Women's Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003268', 'term': 'Contraception Behavior'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spa@kumc.edu', 'phone': '913-588-1261', 'title': 'Jaime Caldwell', 'organization': 'KUMCRI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'The behavioral intervention in the study includes access to online educational materials or a health education booklet, and there is no anticipated risk expected for participants, therefore the adverse event is not monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator-This task was changed to a telephone session due to the COVID-19 Pandemic, which banned access to the recruitment sites.\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pilot', 'description': 'These participants will give feedback on the digital, booklet, and survey items of the intervention', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cervical Cancer Literacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.53', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '9.05', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.98', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '11.51', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.99', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '11.07', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.80', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '11.38', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.20', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '11.21', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment', 'description': 'Cervical Cancer Literacy Assessment Tool (C-CLAT) (PMID: 19299678) Adopted 16-items C-CLAT, the sum of scores on all 16 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 16 (maximum).\n\nA higher score represents a higher level of cervical cancer literacy (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Breast Cancer Literacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.44', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '10.92', 'spread': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.54', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '15.45', 'spread': '3.61', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.20', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '15.04', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.13', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '14.53', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.42', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '14.84', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment', 'description': 'Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) Revised 22-items from B-CLAT (with an added item ask "At what age are most women supposed to start having mammograms?") The sum of scores on all 22 items reflects participants breast cancer literacy with a possible total score ranges from 0 (minimum) to 22 (maximum).\n\nA higher score represents a higher level of cervical cancer literacy (i.e., better outcome).\n\n...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Knowledge of Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.33', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.53', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.55', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '6.53', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.59', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '6.29', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.88', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '6.58', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment', 'description': '-Contraceptive knowledge assessment (PMID:27621043) Adopted 8-items Contraceptive knowledge assessment, the sum of scores on all 8 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 8 (maximum).\n\nA higher score represents a higher level of knowledge of contraception.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Beliefs About Acquisition and Use of Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': "-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Strongly Disagree) to 5 (Strongly Agree) A mean score of 10 items represent participants' beliefs of contraceptive barriers, ranges from 1 (minimum) to 5 (maximum).\n\nA higher score represents a higher level of perceived barriers (i.e., worse outcome).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Confidence in Use of Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.92', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.13', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.08', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.26', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.24', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': "-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Very confident) to 5 (Not at all confident).\n\nA mean score of reverse-coded 6 items represent participants' beliefs of contraceptive self-efficacy, ranges from 1 (minimum) to 5 (maximum).\n\nA higher score represents a higher level of contraceptive self-efficacy (i.e., better outcome).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Knowledge of Sexually Transmitted Diseases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.28', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '4.43', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.24', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '5.16', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '4.96', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.46', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': '-STD knowledge questionnaire (PMID: 17016760) Adopted 8-items STD knowledge questionnaire , the sum of scores on all 8 items reflects participants STD knowledge level with a possible total score ranges from 0 (minimum) to 8 (maximum).\n\nA higher score represents a higher level of knowledge of STD.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Confidence Using Condoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.24', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '4.38', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.35', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.45', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.53', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': '-Condom self-efficacy scale (PMID: 1783705) A mean score of 15 items were calculated with a possible range of 1 (minimum) to 7 (maximum).\n\nHigher scores represent a higher level of condom self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'PRIMARY', 'title': 'Attitudes Related to Condom Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'title': 'Pre-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.74', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.03', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.85', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '5.09', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': '24-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.83', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': '36-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.96', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': '-Multidimensional condom attitudes scale (PMID: 8055858) A mean score of 20-items was calculated with possible values range from 1 (minimum) to 7 (maximum).\n\nItems were rated on a 7-point scale ranging from strongly disagree to strongly agree.\n\nHigher mean score indicate more positive attitudes toward condoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).'}, {'type': 'SECONDARY', 'title': 'HPV Vaccination Receipt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'categories': [{'title': 'Not vaccinated', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Vaccinated', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Only at baseline', 'description': "Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question: have you ever had an HPV vaccination? A dichotomized score reflects participants' HPV vaccination receipt with 0 (no) and 1 (yes).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Up to Date Pap Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within 3 years', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}, {'title': '3 to 5 years', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Over 5 years', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Only at baseline', 'description': 'Health Information National Trends Survey-cervical cancer screening question: "When was your last pap screen?" A categorical items with four levels: 1) never; 2) within the past 3 years; 3) between 3 to 5 years; 4) 5 or more years ago.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Up to Date Mammography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'OG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}], 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Less than a year', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '1 to 2 years', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '2 to 5 years', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Over 5 years', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Only at baseline', 'description': 'Health Information National Trends Survey-breast cancer screening question: "When did you have your most recent mammogram to check for breast cancer? The items is only asked for participants over 50 years old. A categorical outcome with five levels: 1) never had a mammogram; 2) a year ago or less; 3) more than 1, up to 2 years ago; 4) more than 2 but no more than 5 years ago; 5) more than 5 years ago', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator-This task was changed to a telephone session due to the COVID-19 Pandemic, which banned access to the recruitment sites.\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'FG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}, {'id': 'FG002', 'title': 'Pilot', 'description': 'These participants will give feedback on the digital, booklet, and survey items of the intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'id': 'BG001', 'title': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.\n\nSHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.83', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '62'}, {'value': '39.1', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '67'}, {'value': '39.45', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '67'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing due to no response.'}, {'title': 'Time Served in Jail or Prison (Lifetime)', 'classes': [{'title': 'Jail', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.33', 'spread': '23.34', 'groupId': 'BG000'}, {'value': '19.68', 'spread': '28.20', 'groupId': 'BG001'}, {'value': '20.49', 'spread': '28.85', 'groupId': 'BG002'}]}]}, {'title': 'Prison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.35', 'spread': '47.63', 'groupId': 'BG000'}, {'value': '30.95', 'spread': '47.06', 'groupId': 'BG001'}, {'value': '32.16', 'spread': '47.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing due to no response.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-28', 'size': 244213, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-24T21:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2019-05-13', 'resultsFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-19', 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical Cancer Literacy', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment', 'description': 'Cervical Cancer Literacy Assessment Tool (C-CLAT) (PMID: 19299678) Adopted 16-items C-CLAT, the sum of scores on all 16 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 16 (maximum).\n\nA higher score represents a higher level of cervical cancer literacy (i.e., better outcome).'}, {'measure': 'Breast Cancer Literacy', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment', 'description': 'Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) Revised 22-items from B-CLAT (with an added item ask "At what age are most women supposed to start having mammograms?") The sum of scores on all 22 items reflects participants breast cancer literacy with a possible total score ranges from 0 (minimum) to 22 (maximum).\n\nA higher score represents a higher level of cervical cancer literacy (i.e., better outcome).\n\n...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk'}, {'measure': 'Knowledge of Contraception', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment', 'description': '-Contraceptive knowledge assessment (PMID:27621043) Adopted 8-items Contraceptive knowledge assessment, the sum of scores on all 8 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 8 (maximum).\n\nA higher score represents a higher level of knowledge of contraception.'}, {'measure': 'Beliefs About Acquisition and Use of Contraception', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': "-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Strongly Disagree) to 5 (Strongly Agree) A mean score of 10 items represent participants' beliefs of contraceptive barriers, ranges from 1 (minimum) to 5 (maximum).\n\nA higher score represents a higher level of perceived barriers (i.e., worse outcome)."}, {'measure': 'Confidence in Use of Contraception', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': "-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Very confident) to 5 (Not at all confident).\n\nA mean score of reverse-coded 6 items represent participants' beliefs of contraceptive self-efficacy, ranges from 1 (minimum) to 5 (maximum).\n\nA higher score represents a higher level of contraceptive self-efficacy (i.e., better outcome)."}, {'measure': 'Knowledge of Sexually Transmitted Diseases', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': '-STD knowledge questionnaire (PMID: 17016760) Adopted 8-items STD knowledge questionnaire , the sum of scores on all 8 items reflects participants STD knowledge level with a possible total score ranges from 0 (minimum) to 8 (maximum).\n\nA higher score represents a higher level of knowledge of STD.'}, {'measure': 'Confidence Using Condoms', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': '-Condom self-efficacy scale (PMID: 1783705) A mean score of 15 items were calculated with a possible range of 1 (minimum) to 7 (maximum).\n\nHigher scores represent a higher level of condom self-efficacy.'}, {'measure': 'Attitudes Related to Condom Use', 'timeFrame': 'Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.', 'description': '-Multidimensional condom attitudes scale (PMID: 8055858) A mean score of 20-items was calculated with possible values range from 1 (minimum) to 7 (maximum).\n\nItems were rated on a 7-point scale ranging from strongly disagree to strongly agree.\n\nHigher mean score indicate more positive attitudes toward condoms.'}], 'secondaryOutcomes': [{'measure': 'HPV Vaccination Receipt', 'timeFrame': 'Only at baseline', 'description': "Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question: have you ever had an HPV vaccination? A dichotomized score reflects participants' HPV vaccination receipt with 0 (no) and 1 (yes)."}, {'measure': 'Up to Date Pap Screening', 'timeFrame': 'Only at baseline', 'description': 'Health Information National Trends Survey-cervical cancer screening question: "When was your last pap screen?" A categorical items with four levels: 1) never; 2) within the past 3 years; 3) between 3 to 5 years; 4) 5 or more years ago.'}, {'measure': 'Up to Date Mammography', 'timeFrame': 'Only at baseline', 'description': 'Health Information National Trends Survey-breast cancer screening question: "When did you have your most recent mammogram to check for breast cancer? The items is only asked for participants over 50 years old. A categorical outcome with five levels: 1) never had a mammogram; 2) a year ago or less; 3) more than 1, up to 2 years ago; 4) more than 2 but no more than 5 years ago; 5) more than 5 years ago'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Jail', 'Vulnerable Populations', 'STD Screening', 'unintended pregnancy'], 'conditions': ['Cervical Cancer', 'Breast Cancer', 'Contraceptive Usage', 'Sexually Transmitted Diseases']}, 'referencesModule': {'references': [{'pmid': '26548678', 'type': 'BACKGROUND', 'citation': 'Ramaswamy M, Kelly PJ. "The Vagina is a Very Tricky Little Thing Down There": Cervical Health Literacy among Incarcerated Women. J Health Care Poor Underserved. 2015 Nov;26(4):1265-85. doi: 10.1353/hpu.2015.0130.'}, {'pmid': '28435785', 'type': 'BACKGROUND', 'citation': 'Ramaswamy M, Lee J, Wickliffe J, Allison M, Emerson A, Kelly PJ. Impact of a brief intervention on cervical health literacy: A waitlist control study with jailed women. Prev Med Rep. 2017 Apr 5;6:314-321. doi: 10.1016/j.pmedr.2017.04.003. eCollection 2017 Jun.'}, {'pmid': '29944694', 'type': 'BACKGROUND', 'citation': 'Kelly PJ, Allison M, Ramaswamy M. Cervical cancer screening among incarcerated women. PLoS One. 2018 Jun 26;13(6):e0199220. doi: 10.1371/journal.pone.0199220. eCollection 2018.'}, {'pmid': '30250761', 'type': 'BACKGROUND', 'citation': 'Pickett ML, Allison M, Twist K, Klemp JR, Ramaswamy M. Breast Cancer Risk Among Women in Jail. Biores Open Access. 2018 Sep 20;7(1):139-144. doi: 10.1089/biores.2018.0018. eCollection 2018.'}, {'pmid': '25555175', 'type': 'BACKGROUND', 'citation': "Ramaswamy M, Chen HF, Cropsey KL, Clarke JG, Kelly PJ. Highly Effective Birth Control Use Before and After Women's Incarceration. J Womens Health (Larchmt). 2015 Jun;24(6):530-9. doi: 10.1089/jwh.2014.4942. Epub 2015 Jan 2."}, {'pmid': '26332929', 'type': 'BACKGROUND', 'citation': 'Ramaswamy M, Kelly PJ. Sexual Health Risk and the Movement of Women Between Disadvantaged Communities and Local Jails. Behav Med. 2015;41(3):115-22. doi: 10.1080/08964289.2015.1024602.'}, {'pmid': '25063589', 'type': 'BACKGROUND', 'citation': 'Ramaswamy M, Simmons R, Kelly PJ. The development of a brief jail-based cervical health promotion intervention. Health Promot Pract. 2015 May;16(3):432-42. doi: 10.1177/1524839914541658. Epub 2014 Jul 25.'}, {'pmid': '19299678', 'type': 'BACKGROUND', 'citation': 'Fernandez ME, Gonzales A, Tortolero-Luna G, Williams J, Saavedra-Embesi M, Chan W, Vernon SW. Effectiveness of Cultivando la Salud: a breast and cervical cancer screening promotion program for low-income Hispanic women. Am J Public Health. 2009 May;99(5):936-43. doi: 10.2105/AJPH.2008.136713. Epub 2009 Mar 19.'}, {'pmid': '20946564', 'type': 'BACKGROUND', 'citation': 'Guvenc G, Akyuz A, Acikel CH. Health Belief Model Scale for Cervical Cancer and Pap Smear Test: psychometric testing. J Adv Nurs. 2011 Feb;67(2):428-37. doi: 10.1111/j.1365-2648.2010.05450.x. Epub 2010 Oct 15.'}, {'pmid': '18004183', 'type': 'BACKGROUND', 'citation': 'Hogenmiller JR, Atwood JR, Lindsey AM, Johnson DR, Hertzog M, Scott JC Jr. Self-efficacy scale for Pap smear screening participation in sheltered women. Nurs Res. 2007 Nov-Dec;56(6):369-77. doi: 10.1097/01.NNR.0000299848.21935.8d.'}, {'pmid': '27621043', 'type': 'BACKGROUND', 'citation': 'Haynes MC, Ryan N, Saleh M, Winkel AF, Ades V. Contraceptive Knowledge Assessment: validity and reliability of a novel contraceptive research tool. Contraception. 2017 Feb;95(2):190-197. doi: 10.1016/j.contraception.2016.09.002. Epub 2016 Sep 9.'}, {'pmid': '18926726', 'type': 'BACKGROUND', 'citation': 'Melnick AL, Rdesinski RE, Creach ED, Choi D, Harvey SM. The influence of nurse home visits, including provision of 3 months of contraceptives and contraceptive counseling, on perceived barriers to contraceptive use and contraceptive use self-efficacy. Womens Health Issues. 2008 Nov-Dec;18(6):471-81. doi: 10.1016/j.whi.2008.07.011. Epub 2008 Oct 15.'}, {'pmid': '17016760', 'type': 'BACKGROUND', 'citation': 'Jaworski BC, Carey MP. Development and psychometric evaluation of a self-administered questionnaire to measure knowledge of sexually transmitted diseases. AIDS Behav. 2007 Jul;11(4):557-74. doi: 10.1007/s10461-006-9168-5. Epub 2006 Oct 3.'}, {'pmid': '8055858', 'type': 'BACKGROUND', 'citation': 'Helweg-Larsen M, Collins BE. The UCLA Multidimensional Condom Attitudes Scale: documenting the complex determinants of condom use in college students. Health Psychol. 1994 May;13(3):224-37. doi: 10.1037//0278-6133.13.3.224.'}, {'pmid': '1783705', 'type': 'BACKGROUND', 'citation': 'Brafford LJ, Beck KH. Development and validation of a condom self-efficacy scale for college students. J Am Coll Health. 1991 Mar;39(5):219-25. doi: 10.1080/07448481.1991.9936238.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to expand the reach of an existing cervical cancer literacy and prevention intervention- the Sexual Health Empowerment (SHE) Project . As a logical extension of the investigators earlier work, the objective of this renewal is to expand reach of SHE to address women's health disparities more broadly to create a sustainable model for dissemination of health promotion interventions for vulnerable populations.", 'detailedDescription': "Over the last 35 years, there has been a 700% increase in the number of women in prisons and jails. These women, mostly women of color, have pervasive trauma histories, mental health problems, and drug use, all of which compromise their ability to engage in preventive health behaviors. For the last eight years, the research team has studied women leaving jail and why they are 4-5 times more likely to develop cervical cancer, a disparity that has remained unchanged for over 50 years. The original objective of the Sexual Health Empowerment (SHE) for Cervical Health Literacy and Prevention program (R01 CA181047) was to assess the effectiveness of a jail-based intervention to increase cervical health literacy and screening. SHE increased jailed women's cervical health literacy and rates of cancer screening after the women left jail.\n\nWhile delivering SHE, researchers observed: 1) the cross-cutting nature of women's health risk factors, i.e. the risks that jailed women faced for cervical cancer also could lead to other women's health problems; and 2) opportunity for taking an evidence-based intervention, with a rich theoretical framing, to expand to other women's health issues faced by this group, around, not only cervical cancer prevention, but also breast cancer, unintended pregnancy, and STI prevention. While following women after release from jail (85% follow-up rate after 3 years), investigators also identified strategies for reaching this high-risk population through electronic communication. SHE participants were high users of mobile phones (88%), text (76%), Web (79%), and Facebook (70%). This renewal application presents an opportunity to holistically address health disparities experienced by women leaving jail and test new modalities for intervention delivery given use of electronic communication and social media.\n\nThe first aim uses an RCT to test the effectiveness of SHE-Women with women leaving jail on increasing women's health literacy, screening, and risk reduction practices (for cervical, breast cancer, unintended pregnancy, and STIs) against a standard of care. The second aim will be to understand the role and impact of human interaction in electronic interventions by tracking participants and interviewing key stakeholders.\n\nKnowledge gained from this study will lead to an understanding of: 1) how a comprehensive women's health literacy intervention can narrow health disparities among justice-involved women and 2) the role of human interaction in successful electronic interventions, thereby creating a sustainable model for dissemination of health promotion interventions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Scheduled to leave jail within 3 days\n\nExclusion Criteria:\n\n* not actively intoxicated\n* not show severe psychological distress'}, 'identificationModule': {'nctId': 'NCT03984695', 'acronym': 'SHE-WOMEN', 'briefTitle': "Sexual Health Empowerment for Women's Health", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Sexual Health Empowerment for Jail-Involved Women's Health Literacy and Prevention", 'orgStudyIdInfo': {'id': 'STUDY00143316'}, 'secondaryIdInfos': [{'id': '5R01CA181047-10', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA181047-10', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '* 15 minute discharge planning session with health educator\n* Health education booklet containing SHE-Women intervention content in print form(N\\~100)\n* access to health educator via text message'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Deliver text-Web intervention to (N \\~100) women\n\nResearchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \\~10 hours pushed to participants over approximately a 5-day period.", 'interventionNames': ['Behavioral: SHE-WOMEN']}], 'interventions': [{'name': 'SHE-WOMEN', 'type': 'BEHAVIORAL', 'description': "SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64106', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Jackson County Correctional Facility', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Jason Glenn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jason E Glenn, PhD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}