Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT04621760
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The OPENS Trial: Offering Women PrEP (Aim 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dominika.Seidman@ucsf.edu', 'phone': '(415) 353-2119', 'title': 'Dr. Dominika Seidman', 'organization': 'University of California, San-Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'COVID-19 disrupted normal clinic operations, including limiting HIV/PrEP counseling, and paused a state-wide PrEP campaign for cisgender women. This study was conducted at a single, publicly funded clinic with few providers and recruited primarily English-speaking participants and is not generalizeable to other populations. Further, there were too few participants who identified as non-cisgender women or reported injection drug use to report on experiences of those populations.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk.", 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PrEP Prescriptions (As Measured by Chart Review)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post baseline visit', 'description': 'The number of participants who received a PrEP prescription within 3 months of their baseline visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription /No, did not receive a PrEP prescription).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed study activities at T1'}, {'type': 'SECONDARY', 'title': 'Number of Patients Reporting PrEP Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "one sided Fisher's exct test, given small cell sizes."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post baseline visit', 'description': 'Patients will be contacted at follow-up and asked if they took PrEP in the past 3 months regardless of where it was obtained. Outcome is dichotomous ("yes", initiated PrEP within 3 months of initial visit or "no", did not initiate PrEP within 3 months of initial visit).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed one-month follow up survey'}, {'type': 'SECONDARY', 'title': 'Change in Patient-Perceived HIV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'title': 'No Change', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}, {'title': 'Increased Worry', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Decreased Worry', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.207', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test used due to small sample size"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, pre-intervention compared to immediately post baseline visit', 'description': 'We will measure the change in HIV risk perception in the next 6 months from pre- to post-visit at baseline. Response options include 4-point scale: 1 ("Not at all worried") to 4 ("Extremely worried").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed post-visit survey.'}, {'type': 'SECONDARY', 'title': 'Patient-Perceived HIV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'title': 'Extremely worried', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Very worried', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little worried', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Not at all worried', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.496', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test used due to small cell size"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants will be asked about how worried they are about getting HIV in the next 6 months. Response options include 4-point scale of 1 ("Not at all worried") to 4 ("Extremely worried").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed baseline survey.'}, {'type': 'SECONDARY', 'title': 'PrEP Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'PrEP is a daily pill to prevent HIV', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'PrEP is for all adults', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'PrEP will not work if taken once a week', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'PrEP does not prevent STDs other than HIV', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'PrEP side effects do not last forever', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'A baby could be born to HIV discordant parents without transmitting HIV', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'There is medication that you can take after sex to prevent HIV (PEP)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'PrEP efficacy is > 95%', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test comparing proportion correctly identifying "PrEP is a daily pill to prevent HIV"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test comparing proportion correctly responding to prompt: "PrEP is for all adults"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test comparing proportion who correctly identified: "PrEP will not work if taken once a week"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test of proportion who correctly identified "PrEP does not prevent STDs other than HIV"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test comparing proportion who correctly identified, "PrEP side effects do not last forever"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test comparing proportion who correctly identified, "A baby could be norm to HIV discordant parents without transmitting HIV', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test comparing proportion who correctly identified "There is medication you can take after sex to prevent HIV"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Test for proportion who correctly identified "PrEP efficacy is \\> 95%"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Decisional Conflict scale: 16-item scale to measure decisional conflict. Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[no decisional conflict\\] to 100 \\[extremely high decisional conflict\\]. Higher scores represent high decisional conflict.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed post-visit survey'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict - Uncertainty Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure uncertainty: "I am clear about the best choice for me", "I feel sure about what to choose", and "the decision is easy for me to make". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely certain about best choice\\] to 100 \\[feels extremely uncertain about decision\\]. Higher scores represent greater decision uncertainty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict - Informed Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure the informed subscale: "I know which options are available to me", "I know the benefits of each option", and "I know the risks and side effects of each option". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely informed\\] to 100 \\[feels extremely uninformed\\]. Higher scores represent a greater degree of feeling uninformed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict - Values Clarity Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure values clarity: "I am clear about which benefits matter the most to me", "I am clear about which risks and side effects matter most to me", and "I am clear about which is more important to me (the benefits or the risks and side effects." Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely clear about personal values for benefits and risks/side effects\\] to 100 \\[feels extremely unclear about personal values\\].', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict - Support Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure support: "I have enough support from others to make a choice", "I am choosing without pressure from others", and "I have enough advice to make a choice". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely supported in decision making\\] to 100 \\[feels extremely unsupported in decision making\\].', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict - Effective Decision Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Four items from the Decisional Conflict scale will measure effective decision: "I feel I have made an informed choice", "my decision shows what is important to me", "I expect to stick with my decision", and "I am satisfied with my decision". Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[good decision\\] to 100 \\[bad decision\\].', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Interpersonal Quality of HIV Prevention Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post baseline visit', 'description': 'Mean score of 4-item scale. Derived from the Person-Centered Contraceptive Care measure developed by the PI. Response options consist of 5-point Likert scale: 1 ("strongly disagree") to 5 ("strongly agree"). Scores will be dichotomized between 20 \\[excellent interpersonal quality of care\\] and less than 20 \\[poor interpersonal quality of care\\].', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Intention to Use Any HIV Prevention Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'Any method', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Abstinence', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Condoms', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'PEP', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'PrEP', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Regular HIV testing', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Regular STD testing', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Treatment as prevention', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test used due to small cell size"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'A one-time, one-item measure of plan to use HIV prevention method after the initial visit. Participants can select from "none", condoms, PrEP, post exposure prophylaxis (PEP), treatment as prevention, regular HIV testing (inclusive of partner), "still thinking about my options", or other method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Confidence in Decision to Use an HIV Prevention Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Condoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'PEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Regular HIV testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Regular STD testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Treatment as prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'title': 'I feel completely unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'I feel mostly unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'I feel mostly sure', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'I feel 100% sure', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing confidence between treatment groups of those who said they intended to use PrEP', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing confidence between treatment groups of those who said they intended to use abstinence', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing confidence between treatment groups of those who said they intended to use PEP', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing confidence between treatment groups of those who said they intended to use HIV testing', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing confidence between treatment groups of those who said they intended to use STD testing', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing confidence between treatment groups of those who said they intended to use Treatment as Prevention', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'A one-time, one-item measure of certainty of plan to use HIV prevention after the initial visit. Participants can select from 4 options: 1 ("completely unsure"), 2 ("mostly unsure"), 3 ("mostly sure, but not 100%"), or 4 ("100% sure").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Information Received About HIV Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Neither satisfied nor unsatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Somewhat unsatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very unsatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'I was not given information about HIV prevention', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants will be asked a one-time question regarding satisfaction with HIV prevention counseling. Response options include: 1 ("I was not given any information about HIV), 2 ("very unsatisfied") 3 ("somewhat unsatisfied), 4 ("neither satisfied or unsatisfied"), 5 ("somewhat satisfied") and 6 ("very satisfied").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Perceived Quality of Information Received About HIV Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'I got all the information I needed (strongly agree)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Information was easy to understand (strongly agree)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Trusted the information given (strongly agree)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Found the information useful (strongly agree)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing proportions in response to prompt "The information was easy to understand"', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing proportions in response to prompt: "I got all of the information I needed"', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'groupDescription': 'Comparing proportions in response to prompt: "The information felt useful to me"', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants will be asked four questions about the perceived quality of the HIV prevention information patients received during their health care visit: 1) getting the information they needed, 2) the ease of understanding the information, 3) the trustworthiness of the information, and 4), the usefulness of the information. These questions will be asked of those who reported talking about HIV/HIV prevention during their visit with the healthcare provider or health educator OR those who talked to the healthcare provider or health educator about their chances of getting HIV. Response options are 1 to 5 "strongly disagree" to "strongly agree". Higher values indicate greater perceived quality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Acceptability of HIV Prevention Methods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'Abstinence (great method for me)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Condoms (great method for me)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'PEP (great method for me)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'PrEP (great method for me)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'HIV Testing (great method for me)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'STD Tesating (great method for me)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Treatment as prevention (great method for me)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of abstinence method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of condoms method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of PEP method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of PrEP method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of HIV testing method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of STD testing method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing proportion of acceptability of Treatment as prevention method (proportion that responded "great for me")', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants are asked to rate their preference for a method (even if they never used it). Participants can select from condoms, PrEP, PEP, partner HIV testing, regular STD testing, treatment as prevention or other method. The option, "never heard of it" is also included. Options for this scale range from 0 ("Terrible method for me") to 10 ("Great method for me").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed immediate post-visit survey'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Decision Support Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'Got all of the information I need from the DST (strongly agree or agree)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Information on the DST was easy to understand (strongly agree or agree)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'I trusted the information on the DST (strongly agree or agree)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'The information felt helpful to me (strongly agree or agree)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants are asked four questions about their experiences using the DST (e.g., degree to which they got all the information they needed, found the information to be easy to understand, trust the information, and found information useful). Response items vary from strongly disagree to strongly agree.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'group randomized to the DST'}, {'type': 'SECONDARY', 'title': 'Perception of the Decision Support Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'title': 'I really liked it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'I somewhat liked it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'I somewhat disliked it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked about the degree to which they liked/disliked the tool. Response options vary: "I did not like it at all", "I somewhat disliked it", "I somewhat liked it", "I really liked it".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Group randomized to DST'}, {'type': 'SECONDARY', 'title': 'Satisfaction With the Decision Support Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Neither satisfied nor unsatisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Very unsatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked about the degree to which they were satisfied with the information in the tool. Response options vary from 1-5: "very unsatisfied" to "very satisfied".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Group randomized to the DST'}, {'type': 'SECONDARY', 'title': 'Recommend the Decision Support Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked whether they would recommend the tool a friend. Response options are "yes", "no", "unsure".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Group randomized to the DST'}, {'type': 'SECONDARY', 'title': 'Willingness to Use the Decision Support Tool at Future Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked about whether they would use the tool again if they returned to the clinic. Response options are "yes", "no", "unsure".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Group randomized to the DST'}, {'type': 'SECONDARY', 'title': 'HIV Prevention Method Use (Any Method - Planned or New Method)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post baseline visit', 'description': 'A self-reported measure of HIV prevention method use, including those who reported discontinuing the initial HIV prevention method(s) that were reported post-clinic visit. A response of "yes" to any of the following questions: since your \\[baseline\\] visit, have you used….for HIV prevention - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, other method. The outcome will be dichotomized to those who responded affirmatively vs other responses ("no"/"unsure").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'HIV Prevention Method Continuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'OG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance: 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post baseline visit', 'description': 'A self-reported measure of HIV prevention method continuation. A response of "yes" to any of the following questions: are you still using - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, other method. The outcome will be dichotomized to those who responded "yes" vs "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed 3-month follow-up survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'FG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Protocol deviation resulted in 9 participants randomized to control not using the DST. 1 instance of technological issues and 8 instances of clinic time flow constraints.', 'groupId': 'FG000', 'numSubjects': '95'}, {'comment': 'Protocol deviation due to user error resulted in 4 participants not being randomized to control or intervention. Those 4 participants were defaulted to the control group.', 'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Individuals will be handed a flyer about the study and eligibility criteria when they present to the front desk for check in.\n\nInterested individuals are then brought back to a private clinic room for an eligibility screening. Eligible individuals will then be enrolled into the study and randomized to either the control or intervention.', 'preAssignmentDetails': '3 individuals did not meet inclusion criteria. 4 individuals did not want to participate after learning more about the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV Prevention DST Intervention', 'description': "Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.\n\nHIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk."}, {'id': 'BG001', 'title': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.\n\nStandard Counseling: Participants in this arm will receive usual care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '18-24 years old', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '25-29 years old', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '30-34 years old', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '35-44 years old', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age collected on range from: 18-24; 25-29; 30-34; 35-44', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Gender non-conforming or non-binary', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender identification of participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'African American/Black', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Mixed race or multiracial', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race and ethnicity of of participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Parental Education', 'classes': [{'categories': [{'title': '8th grade or less', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Some high school', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'High school graduate', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'College graduate or greater', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Highest educational level reached by participant's parent.", 'unitOfMeasure': 'Participants'}, {'title': 'Yearly Income', 'classes': [{'categories': [{'title': '< $10,000', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': '$10,000-$19,999', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '$20,000-$29,999', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '$30,000-$39,999', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Over $40,000', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Total yearly income of participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Educational Attainment', 'classes': [{'categories': [{'title': '8th grade or less', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Still in high school', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '< high school diploma', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'High school graduate', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': '4-yr college graduate or more', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Highest educational level reached by participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity', 'classes': [{'categories': [{'title': 'Hispanic/Latine', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic/Latine', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The ethnicity of the participant as either Hispanic/Latine or not Hispanic/Latine', 'unitOfMeasure': 'Participants'}, {'title': 'Housing Status', 'classes': [{'categories': [{'title': 'Rent or own', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Housing insecure', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Housing status of the participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Language Spoken at Home', 'classes': [{'categories': [{'title': 'English', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'Spanish', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Mandarin', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Language spoken in the participant's home.", 'unitOfMeasure': 'Participants'}, {'title': 'Relationship Status', 'classes': [{'categories': [{'title': 'Not in a relationship', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'In a relationship with one person', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'In a relationship with more than one person', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The current relationship status of the participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of monogamous participants', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Question finding out if the participant is monogamous, meaning in a relationship with only one other person.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who had condomless vaginal sex, past 6 months', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question finding out if the participant has had vaginal sex without a condom in the past 6 months.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who had anal sex, past 6 months', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has had anal sex in the past 6 months.', 'unitOfMeasure': 'Participants'}, {'title': 'STD Diagnosis History', 'classes': [{'title': 'Ever Had Chlamydia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Ever Had Gonorrhea', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Ever Had Hepatitis C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Ever Had Syphilis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Ever Had Trichomonas', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has ever been diagnosed with chlamydia, gonorrhea, hepatitis C, syphilis, or trichomonas.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who have experienced domestic violence, ever', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has ever felt unsafe in a relationship.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who engaged in binge drinking weekly or more frequently, past 6 months', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has engaged in binge drinking weekly or more frequently in the past 6 months.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who have injected drugs, ever', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has ever injected drugs.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who have used illicit substances, ever', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has ever used any illicit substance.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who have experienced hunger, past year', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has gone hungry in the past year.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who have been to jail or prison, ever', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant has ever been to jail or prison.', 'unitOfMeasure': 'Participants'}, {'title': 'Birth History', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Once', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Twice', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Three or more times', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking how many times the participant has given birth.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who are currently breastfeeding', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant is currently breastfeeding.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who are currently pregnant', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant is currently pregnant.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who are currently trying to get pregnant', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant is currently trying to get pregnant.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who are currently using or plan to use condoms as contraception', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant is using or planning to use condoms as a form of contraception.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants who are using or plan to use most/moderately effectively contraception', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A question asking if the participant is using or planning to use a mostly or moderately effective form of contraception.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-29', 'size': 619564, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-23T10:38', 'hasProtocol': True}, {'date': '2024-03-13', 'size': 329512, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-23T12:58', 'hasProtocol': False}, {'date': '2020-10-29', 'size': 232431, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-23T10:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HIV Prevention Decision Support Tool (DST) - An interactive, tablet-based decision support tool that is designed to help women consider options to reduce their risk of HIV, with emphasis on PrEP as an emerging HIV prevention tool for women.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2023-10-11', 'completionDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2020-10-09', 'resultsFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2020-11-06', 'dispFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-23', 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Prescriptions (As Measured by Chart Review)', 'timeFrame': '3 months post baseline visit', 'description': 'The number of participants who received a PrEP prescription within 3 months of their baseline visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription /No, did not receive a PrEP prescription).'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Reporting PrEP Use', 'timeFrame': '3 months post baseline visit', 'description': 'Patients will be contacted at follow-up and asked if they took PrEP in the past 3 months regardless of where it was obtained. Outcome is dichotomous ("yes", initiated PrEP within 3 months of initial visit or "no", did not initiate PrEP within 3 months of initial visit).'}, {'measure': 'Change in Patient-Perceived HIV Risk', 'timeFrame': 'Baseline, pre-intervention compared to immediately post baseline visit', 'description': 'We will measure the change in HIV risk perception in the next 6 months from pre- to post-visit at baseline. Response options include 4-point scale: 1 ("Not at all worried") to 4 ("Extremely worried").'}, {'measure': 'Patient-Perceived HIV Risk', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants will be asked about how worried they are about getting HIV in the next 6 months. Response options include 4-point scale of 1 ("Not at all worried") to 4 ("Extremely worried").'}, {'measure': 'PrEP Knowledge', 'timeFrame': 'Immediately post baseline visit', 'description': 'Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge.'}, {'measure': 'Decisional Conflict - Total Score', 'timeFrame': 'Immediately post baseline visit', 'description': 'Decisional Conflict scale: 16-item scale to measure decisional conflict. Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[no decisional conflict\\] to 100 \\[extremely high decisional conflict\\]. Higher scores represent high decisional conflict.'}, {'measure': 'Decisional Conflict - Uncertainty Subscore', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure uncertainty: "I am clear about the best choice for me", "I feel sure about what to choose", and "the decision is easy for me to make". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely certain about best choice\\] to 100 \\[feels extremely uncertain about decision\\]. Higher scores represent greater decision uncertainty.'}, {'measure': 'Decisional Conflict - Informed Subscore', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure the informed subscale: "I know which options are available to me", "I know the benefits of each option", and "I know the risks and side effects of each option". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely informed\\] to 100 \\[feels extremely uninformed\\]. Higher scores represent a greater degree of feeling uninformed.'}, {'measure': 'Decisional Conflict - Values Clarity Subscore', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure values clarity: "I am clear about which benefits matter the most to me", "I am clear about which risks and side effects matter most to me", and "I am clear about which is more important to me (the benefits or the risks and side effects." Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely clear about personal values for benefits and risks/side effects\\] to 100 \\[feels extremely unclear about personal values\\].'}, {'measure': 'Decisional Conflict - Support Subscore', 'timeFrame': 'Immediately post baseline visit', 'description': 'Three items from the Decisional Conflict scale will measure support: "I have enough support from others to make a choice", "I am choosing without pressure from others", and "I have enough advice to make a choice". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[feels extremely supported in decision making\\] to 100 \\[feels extremely unsupported in decision making\\].'}, {'measure': 'Decisional Conflict - Effective Decision Subscore', 'timeFrame': 'Immediately post baseline visit', 'description': 'Four items from the Decisional Conflict scale will measure effective decision: "I feel I have made an informed choice", "my decision shows what is important to me", "I expect to stick with my decision", and "I am satisfied with my decision". Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 \\[good decision\\] to 100 \\[bad decision\\].'}, {'measure': 'Interpersonal Quality of HIV Prevention Care', 'timeFrame': 'Immediately post baseline visit', 'description': 'Mean score of 4-item scale. Derived from the Person-Centered Contraceptive Care measure developed by the PI. Response options consist of 5-point Likert scale: 1 ("strongly disagree") to 5 ("strongly agree"). Scores will be dichotomized between 20 \\[excellent interpersonal quality of care\\] and less than 20 \\[poor interpersonal quality of care\\].'}, {'measure': 'Intention to Use Any HIV Prevention Method', 'timeFrame': 'Immediately post baseline visit', 'description': 'A one-time, one-item measure of plan to use HIV prevention method after the initial visit. Participants can select from "none", condoms, PrEP, post exposure prophylaxis (PEP), treatment as prevention, regular HIV testing (inclusive of partner), "still thinking about my options", or other method.'}, {'measure': 'Confidence in Decision to Use an HIV Prevention Method', 'timeFrame': 'Immediately post baseline visit', 'description': 'A one-time, one-item measure of certainty of plan to use HIV prevention after the initial visit. Participants can select from 4 options: 1 ("completely unsure"), 2 ("mostly unsure"), 3 ("mostly sure, but not 100%"), or 4 ("100% sure").'}, {'measure': 'Satisfaction With Information Received About HIV Prevention', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants will be asked a one-time question regarding satisfaction with HIV prevention counseling. Response options include: 1 ("I was not given any information about HIV), 2 ("very unsatisfied") 3 ("somewhat unsatisfied), 4 ("neither satisfied or unsatisfied"), 5 ("somewhat satisfied") and 6 ("very satisfied").'}, {'measure': 'Perceived Quality of Information Received About HIV Prevention', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants will be asked four questions about the perceived quality of the HIV prevention information patients received during their health care visit: 1) getting the information they needed, 2) the ease of understanding the information, 3) the trustworthiness of the information, and 4), the usefulness of the information. These questions will be asked of those who reported talking about HIV/HIV prevention during their visit with the healthcare provider or health educator OR those who talked to the healthcare provider or health educator about their chances of getting HIV. Response options are 1 to 5 "strongly disagree" to "strongly agree". Higher values indicate greater perceived quality.'}, {'measure': 'Acceptability of HIV Prevention Methods', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants are asked to rate their preference for a method (even if they never used it). Participants can select from condoms, PrEP, PEP, partner HIV testing, regular STD testing, treatment as prevention or other method. The option, "never heard of it" is also included. Options for this scale range from 0 ("Terrible method for me") to 10 ("Great method for me").'}, {'measure': 'Acceptability of the Decision Support Tool', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants are asked four questions about their experiences using the DST (e.g., degree to which they got all the information they needed, found the information to be easy to understand, trust the information, and found information useful). Response items vary from strongly disagree to strongly agree.'}, {'measure': 'Perception of the Decision Support Tool', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked about the degree to which they liked/disliked the tool. Response options vary: "I did not like it at all", "I somewhat disliked it", "I somewhat liked it", "I really liked it".'}, {'measure': 'Satisfaction With the Decision Support Tool', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked about the degree to which they were satisfied with the information in the tool. Response options vary from 1-5: "very unsatisfied" to "very satisfied".'}, {'measure': 'Recommend the Decision Support Tool', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked whether they would recommend the tool a friend. Response options are "yes", "no", "unsure".'}, {'measure': 'Willingness to Use the Decision Support Tool at Future Visits', 'timeFrame': 'Immediately post baseline visit', 'description': 'Participants in the experimental arm will be asked about whether they would use the tool again if they returned to the clinic. Response options are "yes", "no", "unsure".'}, {'measure': 'HIV Prevention Method Use (Any Method - Planned or New Method)', 'timeFrame': '3 months post baseline visit', 'description': 'A self-reported measure of HIV prevention method use, including those who reported discontinuing the initial HIV prevention method(s) that were reported post-clinic visit. A response of "yes" to any of the following questions: since your \\[baseline\\] visit, have you used….for HIV prevention - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, other method. The outcome will be dichotomized to those who responded affirmatively vs other responses ("no"/"unsure").'}, {'measure': 'HIV Prevention Method Continuation', 'timeFrame': '3 months post baseline visit', 'description': 'A self-reported measure of HIV prevention method continuation. A response of "yes" to any of the following questions: are you still using - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, other method. The outcome will be dichotomized to those who responded "yes" vs "no".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-exposure prophylaxis (PrEP)', 'HIV prevention behaviors', 'HIV prevention methods', 'HIV education', 'African American, Latina, women of color', 'Shared decision making', 'Decision making, shared', 'Patient decision support', 'Patient decision aid'], 'conditions': ['Human Immunodeficiency Virus Transmission', 'Sexually Transmitted Diseases']}, 'descriptionModule': {'briefSummary': "To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is one part of a multi-component project and involves a patient-level intervention in one public health family planning clinic in Duval County Florida, where the majority of patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed a tablet-based decision support tool that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV. Participants will be randomized to use the HIV decision support tool before their visit or standard counseling (without the use of the tool) and will be surveyed about the use of the tool, experiences with HIV prevention counseling, and intentions about the use of HIV prevention. A subset of participants, all individuals who self-identify as a woman and as Black or Latina, will also complete a post-clinic visit interview. The investigators will follow-up with participants at three months following their initial visit to see if they have initiated the HIV prevention method(s) they chose at their visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options.\n\nHypotheses:\n\n1. Women who use the HIV prevention decision support tool will be more likely to have initiated PrEP within 3 months compared to women who received standard counseling at the time of their initial appointment.\n2. The HIV prevention decision support tool will increase women's knowledge of PrEP and other HIV prevention methods compared to women who received standard counseling at the time of their initial appointment.\n3. The HIV prevention decision support tool will increase participants' decisional certainty in their choice of an HIV prevention method compared to women who received standard counseling at the time of their initial appointment.", 'detailedDescription': "Although 13% of the U.S. female population is Black, 60% of new HIV diagnoses in U.S. women occur among Black women. The South is the epicenter of the U.S. HIV epidemic, including in women, and Black Southern women are disproportionately affected: Black women account for 69% of new HIV diagnoses in women in the South. As the first highly effective, discrete, woman-controlled HIV prevention method, oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine radically expands HIV prevention options for women. However, uptake of PrEP in U.S. women has lagged, particularly among groups most affected by HIV.\n\nPrEP cascades outline the necessary steps for accessing PrEP, including screening and identifying eligible individuals, linkage to care, prescription, and initiation of PrEP. Data suggest there are multilevel barriers related to the process of screening for HIV risk in women and identifying potential PrEP candidates that may drive a significant drop off early in the PrEP cascade for women. Women report feeling judged by risk assessment questions and experience stigma around disclosing sexual practices. As a result, if screening is required to educate patients about PrEP - as is true in most clinical settings - many women for whom PrEP is appropriate may never learn about PrEP. Further, women have low levels of knowledge about HIV risk and HIV prevention options, and therefore will not seek out PrEP services themselves. By offering education to all women about vulnerabilities to HIV as well as information about HIV prevention methods including PrEP, at-risk women can circumvent these multifactorial barriers and request PrEP. Electronic decision support tools (DST), which have been used with success in a range of healthcare contexts including contraception, provide an efficient and private mechanism for this information-sharing step.\n\nThe study team developed a tablet-based tool that is designed to provide universal PrEP education and facilitate women's agency to identify their own risks and interest in PrEP. It was refined with iterative feedback from patient and community stakeholders and finalized based on cognitive testing.\n\nThe DST provides information about vulnerabilities to HIV and core characteristics of different HIV prevention methods, and then the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The user chooses the level of information that they wish to receive through the interactive interface, allowing for an individualized experience. Upon reaching the end of the tool, information on the tablet suggests that women ask their provider about HIV prevention methods they are interested in using, based on their preferences for method characteristics, and their questions in order to facilitate deliberation with the provider. The DST takes approximately 10 minutes to complete.\n\nApproximately 200 women presenting to one reproductive health clinic in Duval County, Florida, will be randomized to standard counseling plus use of an HIV prevention DST, providing education about PrEP and encouraging self-assessment of HIV risk, or standard counseling alone. In addition to the experimental intervention, a subset of 40 participants (20 per arm) will be asked to allow audio-recording of their counseling sessions with a provider. A subset of up to 40 additional participants (20 per arm), all of whom self-identify as women of color, will be invited to complete one-hour, semi-structured interviews after their clinic visit about their experiences of using the DST, HIV prevention counseling, and decision making about PrEP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants have to identify as a woman.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as a woman (regardless of pregnancy status)\n* Age 18 - 45 years\n* Not known to be living with HIV (based on self-report)\n* English-speaking\n* Interested in participating\n\nExclusion Criteria:\n\n* Unable to consent\n* Currently using PrEP\n* Those who were assigned male at birth and self-identify as a man\n* Unwilling to be contacted in 3 months\n* Already participated in the study'}, 'identificationModule': {'nctId': 'NCT04621760', 'briefTitle': 'The OPENS Trial: Offering Women PrEP (Aim 1)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Offering Women PrEP With Education and Shared Decision-making', 'orgStudyIdInfo': {'id': '2020-014-FDOH'}, 'secondaryIdInfos': [{'id': '3R01MD013565', 'link': 'https://reporter.nih.gov/quickSearch/3R01MD013565', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV Prevention DST Intervention', 'description': 'Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.', 'interventionNames': ['Behavioral: HIV Prevention Decision Support Tool (DST)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Counseling', 'description': 'Participants in this arm will receive usual care.', 'interventionNames': ['Behavioral: Standard Counseling']}], 'interventions': [{'name': 'HIV Prevention Decision Support Tool (DST)', 'type': 'BEHAVIORAL', 'description': "The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk.", 'armGroupLabels': ['HIV Prevention DST Intervention']}, {'name': 'Standard Counseling', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will receive usual care.', 'armGroupLabels': ['Standard Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32211', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Department of Health in Duval County', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Christine Dehlendorf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Akilah Pope, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Department of Health in Duval County'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Department of Health', 'class': 'OTHER_GOV'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}