Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-28 @ 2:29 PM
Study NCT ID:
NCT02934620
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Promoting CSD500 Use Among Women in Established Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047568', 'term': 'Unsafe Sex'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'gallo.86@osu.edu', 'phone': '16146882145', 'title': 'Maria Gallo', 'organization': 'Ohio State University, College of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The number of participants at risk for all the adverse event terms are less than the \\*\\*Total\\*\\* number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk.\n\nOther (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.', 'eventGroups': [{'id': 'EG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.", 'otherNumAtRisk': 240, 'deathsNumAtRisk': 248, 'otherNumAffected': 68, 'seriousNumAtRisk': 248, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.", 'otherNumAtRisk': 240, 'deathsNumAtRisk': 252, 'otherNumAffected': 2, 'seriousNumAtRisk': 252, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CSD500 Condom - Male Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 248, 'otherNumAffected': 0, 'seriousNumAtRisk': 248, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard Condom -Male Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 252, 'otherNumAffected': 0, 'seriousNumAtRisk': 252, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headaches at 2-month among Female Participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches at 4-month among Female Participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches at 6-month among Female Participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness at 2 months among Female Participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness at 4 months among Female Participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Female Participants With Positive PSA at 2-Month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vaginal swab collected at 2-month follow-up visit', 'description': 'A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'PRIMARY', 'title': 'Number of Female Participants With Positive PSA at 4-Month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vaginal swab collected at 4-month follow-up visit', 'description': 'A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Female Participants With Positive PSA at 6-Month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vaginal swab collected at 6-month follow-up visit', 'description': 'A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at 2-month follow-up visit', 'description': 'Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG002', 'title': 'CSD500 Condom - Male Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG003', 'title': 'Standard Condom - Male Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '5.27', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '277', 'spread': '5.13', 'groupId': 'OG001'}, {'value': '5.48', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '5.27', 'spread': '0.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured among participants at at 6-month follow-up visit', 'description': "The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women and men's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condoms - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '5.27', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured among female participants at at 2-month follow-up visit', 'description': "The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '5.20', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured among female participants at at 4-month follow-up visit', 'description': "The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom- Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at 4-month follow-up visit', 'description': 'Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Receive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'OG001', 'title': 'Standard Condom - Female Participants', 'description': "Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at 6-month follow-up visit', 'description': 'Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'FG001', 'title': 'Standard Condom - Female Participants', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'FG002', 'title': 'CSD500 Condom- Male Partners', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'FG003', 'title': 'Standard Condom - Male Partners', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}], 'periods': [{'title': 'Baseline Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '252'}, {'groupId': 'FG002', 'numSubjects': '248'}, {'groupId': 'FG003', 'numSubjects': '252'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '252'}, {'groupId': 'FG002', 'numSubjects': '248'}, {'groupId': 'FG003', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '2-month Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '252'}, {'comment': 'Male partners were not asked to complete a 2-month visit.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Male partners were not asked to complete a 2-month visit.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '228'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '4-month Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Our study procedures allowed female participants to attend the 4-month visit even if they had not attended the 2-month visit.', 'groupId': 'FG000', 'numSubjects': '248'}, {'comment': 'Our study procedures allowed female participants to attend the 4-month visit even if they had not attended the 2-month visit.', 'groupId': 'FG001', 'numSubjects': '252'}, {'comment': 'Male partners were not asked to complete a 4-month visit.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Male partners were not asked to complete a 4-month visit.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '6-month Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Our study procedures allowed female participants to attend the 6-month visit even if they had not attended the 2-month and/or 4-month visit.', 'groupId': 'FG000', 'numSubjects': '248'}, {'comment': 'Our study procedures allowed female participants to attend the 6-month visit even if they had not attended the 2-month and/or 4-month visit.', 'groupId': 'FG001', 'numSubjects': '252'}, {'groupId': 'FG002', 'numSubjects': '248'}, {'groupId': 'FG003', 'numSubjects': '252'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '239'}, {'groupId': 'FG002', 'numSubjects': '230'}, {'groupId': 'FG003', 'numSubjects': '238'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'CSD500 Condom - Female Participants', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'BG001', 'title': 'Standard Condom - Female Participants', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'BG002', 'title': 'CSD500 Condom - Male Participants', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive CSD500 condoms with condom counseling to use them for sexual pleasure.\n\nCSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'BG003', 'title': 'Standard Condom - Male Participants', 'description': "Male and female partners were enrolled at together as a couple in the study.\n\nReceive the standard condom with condom counseling to use them for pregnancy and disease prevention.\n\nStandard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.\n\nCondom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '500', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Age of male partners was not collected.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '500', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '34.3', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '34.1', 'spread': '5.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age of male partners was not collected.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '500', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '500', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Vietnam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-27', 'size': 1180529, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-06T16:41', 'hasProtocol': True}, {'date': '2017-01-31', 'size': 296169, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-06T16:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2016-10-10', 'resultsFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-29', 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Female Participants With Positive PSA at 2-Month Visit', 'timeFrame': 'Vaginal swab collected at 2-month follow-up visit', 'description': 'A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.'}, {'measure': 'Number of Female Participants With Positive PSA at 4-Month Visit', 'timeFrame': 'Vaginal swab collected at 4-month follow-up visit', 'description': 'A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.'}, {'measure': 'Number of Female Participants With Positive PSA at 6-Month Visit', 'timeFrame': 'Vaginal swab collected at 6-month follow-up visit', 'description': 'A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.'}], 'secondaryOutcomes': [{'measure': 'Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit', 'timeFrame': 'Measured at 2-month follow-up visit', 'description': 'Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.'}, {'measure': 'Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit', 'timeFrame': 'Measured among participants at at 6-month follow-up visit', 'description': "The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women and men's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience."}, {'measure': 'Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit', 'timeFrame': 'Measured among female participants at at 2-month follow-up visit', 'description': "The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience."}, {'measure': 'Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit', 'timeFrame': 'Measured among female participants at at 4-month follow-up visit', 'description': "The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience."}, {'measure': 'Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit', 'timeFrame': 'Measured at 4-month follow-up visit', 'description': 'Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.'}, {'measure': 'Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit', 'timeFrame': 'Measured at 6-month follow-up visit', 'description': 'Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'condom', 'HIV', 'sexually transmitted infections'], 'conditions': ['PSA', 'Unprotected Sex']}, 'referencesModule': {'references': [{'pmid': '35176037', 'type': 'DERIVED', 'citation': 'Nguyen NC, Luong TN, Le VT, Hobbs M, Andridge R, Casterline J, Gallo MF. Effectiveness of erectogenic condom against semen exposure among women in Vietnam: Randomized controlled trial. PLoS One. 2022 Feb 17;17(2):e0263503. doi: 10.1371/journal.pone.0263503. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': "Globally, women in established relationships remain at risk for unintended pregnancy and sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the proposed research, unmet need for contraception is substantial as reflected in the nation's high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and among this group, most were exposed to the virus through sexual activity with their husband. Condoms will remain crucial for prevention for some time to come. Sustained condom use, however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for engaging in sex and is an integral part of overall sexual health, most programs to improve sexual health operate within a pregnancy and disease-prevention paradigm. A new condom, CSD500, containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. The overall objective of the proposed two-arm randomized trial is to test whether promoting the novel condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal sex. Investigators will measure the occurrence of unprotected vaginal sex by testing women's vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological marker of recent semen exposure. Investigators will randomize 500 adult, heterosexual, monogamous couples, comprised of a total of 1000 individuals, in Thanh Hoa province, Vietnam to receive either CSD500 for sexual pleasure or the standard condom currently provided only for pregnancy and disease prevention to patients during routine care. Study staff will interview female participants at enrollment and after 2, 4, and 6 months and their male partners at the 6-month visit. Study clinicians will sample vaginal fluid from female participants at all visits to test for the presence of PSA.", 'detailedDescription': "This randomized controlled trial will test whether promoting the novel condom CSD500 (Futura Medical Developments; Surrey, UK) for improved sexual pleasure results in couples having less unprotected vaginal sex - measured with a biological marker of recent semen exposure - compared to the promotion of a standard condom for disease and pregnancy prevention. CSD500 contains an erectogenic drug and was developed to improve sexual pleasure by increasing penile firmness, size, and erection duration.\n\nInvestigators will recruit eligible, monogamous, heterosexual couples at Thanh Hoa Provincial Centre of Reproductive Health in Vietnam to participate in a randomized controlled trial (RCT) of two balanced arms of approximately 250 heterosexual couples each, for a total of 500 couples, comprised of 1000 individuals. At enrollment and at three follow-up visits scheduled at 2, 4 and 6 months after enrollment, study staff will provide condom counseling, will collect vaginal swabs to test for the semen biomarker, prostate-specific antigen (PSA), and will administer a questionnaire to the female participants on their demographics, sexual and condom-related attitudes and practices, including sexual pleasure and perceptions of partner's sexual pleasure. Although the intervention is directed to the women, couples will be enrolled to ensure that the male partners consent to CSD500 use. After enrollment, male participants will not participate in study visit activities, including data collection, until the time of their female partner's final 6-month visit. Because of the differences in counseling messages, participants and study staff at the site cannot be blinded to arm assignment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (for women):\n\n* Not currently using a modern contraceptive method other than condoms or intending to start using a modern contraceptive method other than condoms in the next 6 months;\n* Willing to use assigned study condoms as the sole method of contraception for the next six months;\n* Not breastfeeding;\n* Not known to be pregnant;\n* Want to avoid pregnancy for at least the next six months; and\n* Be in a monogamous relationship for at least the past six months with her current male partner.\n\nExclusion Criteria (for couples):\n\nCouples are ineligible for study participation if either person in the couple is known to be HIV-positive or has any of the following contraindications to CSD500 use:\n\n* History of low blood pressure or heart condition;\n* Current use of medication for anemia, blood pressure, erectile dysfunction, migraines, headaches or glaucoma;\n* Inflamed or broken skin that the condom could come into contact with; or\n* Latex allergy or sensitivity.'}, 'identificationModule': {'nctId': 'NCT02934620', 'briefTitle': 'Promoting CSD500 Use Among Women in Established Relationships', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Promoting CSD500 Use Among Women in Established Relationships', 'orgStudyIdInfo': {'id': '2015H0242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSD500 Condom', 'description': 'Receive CSD500 condoms with condom counseling to use them for sexual pleasure.', 'interventionNames': ['Device: CSD500 Condom', 'Behavioral: Condom Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Condom', 'description': 'Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.', 'interventionNames': ['Device: Standard Condom', 'Behavioral: Condom Counseling']}], 'interventions': [{'name': 'CSD500 Condom', 'type': 'DEVICE', 'otherNames': ['Blue Diamond'], 'description': 'CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.', 'armGroupLabels': ['CSD500 Condom']}, {'name': 'Standard Condom', 'type': 'DEVICE', 'description': 'The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.', 'armGroupLabels': ['Standard Condom']}, {'name': 'Condom Counseling', 'type': 'BEHAVIORAL', 'description': "The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.", 'armGroupLabels': ['CSD500 Condom', 'Standard Condom']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thanh Hóa', 'state': 'Thanh Hóa Province', 'country': 'Vietnam', 'facility': 'Thanh Hoa Provincial Centre of Reproductive Health', 'geoPoint': {'lat': 19.8, 'lon': 105.76667}}], 'overallOfficials': [{'name': 'Maria Gallo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'John Casterline, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Rebecca Andridge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Marcia Hobbs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Nghia Nguyen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Vietnam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Vietnam', 'class': 'OTHER_GOV'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maria F. Gallo, PhD', 'investigatorAffiliation': 'Ohio State University'}}}}