Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:18 AM
Study NCT ID:
NCT05709860
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2023-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allison.pack@northwestern.edu', 'phone': '312-503-0274', 'title': 'Research Assistant Professor', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed. These were 1-time interviews.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PrEP Uptake (Use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PrEP Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-6 weeks', 'description': 'A 10-item questionnaire, developed by the study team and the scientific literature, will be used to evaluate knowledge of pre-exposure prophylaxis among study participants. Correctly answered questions will be summed (0 to 10) for a total score. Higher scores will indicate greater PrEP knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Risk of HIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-6 weeks', 'description': 'The 8-item Perceived Risk of HIV scale is used to assess how vulnerable an individual feels to HIV. The scale was developed in the United States and attention was paid to health literacy. Response options vary for each item, though they are measured on a 4-point Likert scale. Total score of 8 items is calculated and range from 10 to 40. Higher scores mean higher perceived risk of HIV.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PrEP Attitudes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-6 weeks', 'description': 'A PrEP Attitudes 5-items scale (Walsh, 2019) is used to assess attitudes toward PrEP, each item is measured on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated and range from 5 to 25. Higher scores mean more stigma towards PrEP use.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Literacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'categories': [{'title': 'Limited', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Adequate', 'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 weeks', 'description': "CHEW health literacy is used to assess participant's health literacy level. Participants were asked three questions about difficulty in understanding medical materials and information, the options range from all of the time to none of the time. The responses of the three questions are then categorized into limited and adequate health literacy level. We used CHEW health literacy because the measure can be conducted over phone calls.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'categories': [{'title': 'Low', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'High', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 weeks', 'description': "A modified version of our team's 10-item Consumer Health Activation Index (CHAI) is used to assess participant's engagement in healthcare. Response options are a Likert scale; linear transformation is used to put total scores onto a 0-100 scale, with higher numbers indicating greater activation. The total scores are then categorized into 3 categories: Low (0-79), Moderate (80-94), and High (\\>94).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Process Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'title': 'Received PrEP decision guide in patient portal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Reviewed the material after received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 weeks', 'description': 'The participants in the intervention group were asked two questions about 1) whether they received a PrEP decision guide, and 2) did they read or review it, to assess the acceptability of the intervention material.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants in the intervention group were asked the questions. 43 participants have missing process measure data.'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Strategy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'OG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'classes': [{'title': 'Satisfaction of the appearance of the guide', 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction of the quality of the guide', 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-6 weeks', 'description': 'Using 10-point Likert scale response options (1=very unsatisfied to 10=very satisfied), participants in the intervention group are asked to rate their satisfaction with the materials.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the participants in the intervention group are asked to rate their satisfaction with the intervention materials. And 10 participants in the intervention group who read or view the material were asked about the satisfaction with the material.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'FG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'id': 'BG001', 'title': 'The EMC2 PrEP Strategy', 'description': "The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.\n\nEMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.\n\nDiscrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.1', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White/Caucasian', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Married', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Divorced', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Separated', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Single', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Living with a partner', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Household Income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}], 'categories': [{'title': '< $25,000', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '$25,000-$49,999', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '$50,000-$74,999', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '$75,000-$99,999', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '$100,000 or more', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant in the intervention group has missing income data.'}, {'title': 'Insurance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Private or HMO', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Medicaid', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Medicare', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Self-pay/No insurance', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-13', 'size': 546727, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-30T10:24', 'hasProtocol': True}, {'date': '2024-02-13', 'size': 173521, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-17T11:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2023-01-17', 'resultsFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-05', 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Uptake (Use)', 'timeFrame': '6 months', 'description': 'PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.'}], 'secondaryOutcomes': [{'measure': 'PrEP Knowledge', 'timeFrame': '2-6 weeks', 'description': 'A 10-item questionnaire, developed by the study team and the scientific literature, will be used to evaluate knowledge of pre-exposure prophylaxis among study participants. Correctly answered questions will be summed (0 to 10) for a total score. Higher scores will indicate greater PrEP knowledge.'}, {'measure': 'Perceived Risk of HIV', 'timeFrame': '2-6 weeks', 'description': 'The 8-item Perceived Risk of HIV scale is used to assess how vulnerable an individual feels to HIV. The scale was developed in the United States and attention was paid to health literacy. Response options vary for each item, though they are measured on a 4-point Likert scale. Total score of 8 items is calculated and range from 10 to 40. Higher scores mean higher perceived risk of HIV.'}, {'measure': 'PrEP Attitudes', 'timeFrame': '2-6 weeks', 'description': 'A PrEP Attitudes 5-items scale (Walsh, 2019) is used to assess attitudes toward PrEP, each item is measured on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated and range from 5 to 25. Higher scores mean more stigma towards PrEP use.'}, {'measure': 'Health Literacy', 'timeFrame': '2-6 weeks', 'description': "CHEW health literacy is used to assess participant's health literacy level. Participants were asked three questions about difficulty in understanding medical materials and information, the options range from all of the time to none of the time. The responses of the three questions are then categorized into limited and adequate health literacy level. We used CHEW health literacy because the measure can be conducted over phone calls."}, {'measure': 'Health Activation', 'timeFrame': '2-6 weeks', 'description': "A modified version of our team's 10-item Consumer Health Activation Index (CHAI) is used to assess participant's engagement in healthcare. Response options are a Likert scale; linear transformation is used to put total scores onto a 0-100 scale, with higher numbers indicating greater activation. The total scores are then categorized into 3 categories: Low (0-79), Moderate (80-94), and High (\\>94)."}, {'measure': 'Process Measure', 'timeFrame': '2-6 weeks', 'description': 'The participants in the intervention group were asked two questions about 1) whether they received a PrEP decision guide, and 2) did they read or review it, to assess the acceptability of the intervention material.'}, {'measure': 'Acceptability of the Strategy', 'timeFrame': '2-6 weeks', 'description': 'Using 10-point Likert scale response options (1=very unsatisfied to 10=very satisfied), participants in the intervention group are asked to rate their satisfaction with the materials.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'Electronic Health Record', 'Primary Health Care']}, 'referencesModule': {'references': [{'pmid': '40269861', 'type': 'DERIVED', 'citation': "Pack A, O'Conor R, Vasiloff R, Liebovitz D, Masters MC, Alcantara K, Smith R, Wismer G, Tatz R, Yeh F, Curtis LM, Hur S, Bailey SC. An electronic health record-based strategy to increase PrEP decision-making among cisgender women in primary care: results of a randomized pilot study. BMC Health Serv Res. 2025 Apr 24;25(1):589. doi: 10.1186/s12913-025-12745-2."}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to investigate a strategy that may improve knowledge and uptake of pre-exposure prophylaxis for HIV prevention (PrEP) among cisgender women in primary care.', 'detailedDescription': "Members of the study team previously developed and evaluated the Electronic health record Medication Complete Communication (EMC2) strategy to 'hardwire' provider/patient communication \\& surveillance of select prescription (Rx) medications. EMC2 PrEP will adapt from the previous strategy to\n\n* educate cisgender women in primary care who have increased vulnerability to HIV about PrEP using an interactive, health literacy-appropriate educational tool securely delivered via the patient portal\n* facilitate, for those who express interest, the rapid and discrete scheduling of a dedicated PrEP clinic visit with a primary care clinician trained in PrEP delivery\n\nThe current study aims are to:\n\nAim 1: Refine and implement an electronic health record (EHR)-based strategy as a potential quality improvement activity that supports informed decision-making and PrEP uptake among women with increased HIV vulnerability in primary care (the EMC2 PrEP strategy).\n\nAim 2: Pilot-test the EMC2 PrEP strategy in primary care to determine its feasibility, acceptability, and preliminary efficacy among women with increased vulnerability to HIV.\n\nAim 3: Develop a standard operating protocol (SOP) for disseminating the EMC2 PrEP strategy to a national network of federally qualified health centers."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* HIV negative\n* have received 2 or more tests in the past 12 months for chlamydia, gonorrhea and/or syphilis\n* and/or have received a positive diagnosis for at least one of those sexually transmitted infections in the past 6 months\n* currently engaged in primary care\n* not currently using PrEP\n\nExclusion Criteria:\n\n* severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation'}, 'identificationModule': {'nctId': 'NCT05709860', 'briefTitle': 'An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Adaptation and Pilot Test of an Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy', 'orgStudyIdInfo': {'id': 'STU00217596'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The EMC2 PrEP Strategy', 'description': 'The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.', 'interventionNames': ['Behavioral: EMC2 PrEP Educational Tool', 'Behavioral: Discrete Scheduling of a Dedicated PrEP Visit']}], 'interventions': [{'name': 'EMC2 PrEP Educational Tool', 'type': 'BEHAVIORAL', 'description': 'Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.', 'armGroupLabels': ['The EMC2 PrEP Strategy']}, {'name': 'Discrete Scheduling of a Dedicated PrEP Visit', 'type': 'BEHAVIORAL', 'description': "Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.", 'armGroupLabels': ['The EMC2 PrEP Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Allison Pack, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Allison Prickett Pack', 'investigatorAffiliation': 'Northwestern University'}}}}