Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT06100250
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2023-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D013587', 'term': 'Syphilis'}, {'id': 'D003075', 'term': 'Coitus'}], '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'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'akshaydr@umich.edu', 'phone': '734-647-0151', 'title': 'Dr. Akshay Sharma', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'eventGroups': [{'id': 'EG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Schedule a Pre-test Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all 75 participants who were invited to schedule a pre-test session after completing the baseline survey'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 74 participants who actually scheduled a pre-test session after being invited'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'title': 'Urine sample', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Throat swab', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Rectal swab', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Blood sample', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 16 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 69 participants who were shipped a specimen self-collection box after completing the pre-test session'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Provide Specimens of Adequate Quality for Lab Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'title': 'Urine sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Throat swab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Rectal swab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Blood sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 16 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 57 participants who returned at least one type of specimen after receiving the specimen self-collection box'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Schedule a Post-test Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 57 participants who were invited to schedule a post-test session after returning at least one type of specimen'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 57 participants who actually scheduled a post-test session after being invited'}, {'type': 'PRIMARY', 'title': 'Overall Intervention Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '28.09', 'spread': '2.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' satisfaction with the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater overall intervention satisfaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 47 participants who answered the questions on satisfaction with the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session'}, {'type': 'PRIMARY', 'title': 'Interventionist Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '163.92', 'spread': '20.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' perceptions of the interventionist conducting the pre-test and the post-test sessions will be assessed using two 12-item Counselor Rating Form Short scales included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 24-168, with higher scores indicating more positive interventionist perceptions.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 51 participants who answered the questions on perceptions of the interventionist conducting the pre-test and the post-test sessions'}, {'type': 'PRIMARY', 'title': 'Usability of the Pre-test and the Post-test Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '53.56', 'spread': '7.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' usability of the pre-test and the post-test sessions will be assessed using two 4-item subscales from the Telehealth Usability Questionnaire on the quality of interactions with the interventionist during each session included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 8-56, with higher scores indicating greater usability of the pre-test and the post-test sessions.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 52 participants who answered the questions on usability of the pre-test and the post-test sessions'}, {'type': 'PRIMARY', 'title': 'Willingness to Repeat the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '28.60', 'spread': '2.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' willingness to repeat the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater willingness to repeat the intervention.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 48 participants who answered the questions on willingness to repeat the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session'}, {'type': 'PRIMARY', 'title': 'Likelihood of Recommending the Intervention to Friends or Sex Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '28.33', 'spread': '2.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' likelihood of recommending the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session to friends or sex partners will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater likelihood of recommending the intervention to friends or sex partners.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 46 participants who answered the questions on likelihood of recommending the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session to friends or sex partners'}, {'type': 'SECONDARY', 'title': 'Change in STI-related Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'title': 'Pre-intervention score (from the baseline survey)', 'categories': [{'measurements': [{'value': '16.34', 'spread': '3.48', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention score (from the satisfaction survey)', 'categories': [{'measurements': [{'value': '17.16', 'spread': '3.41', 'groupId': 'OG000'}]}]}, {'title': 'Difference', 'categories': [{'measurements': [{'value': '0.82', 'spread': '2.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.82', 'pValueComment': 'A priori threshold for statistical significance = 0.05', 'estimateComment': 'Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)', 'groupDescription': 'Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0', 'statisticalMethod': 'Paired sample t-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Degrees of freedom = 66', 'nonInferiorityComment': 'Paired sample t-test, 2 sided'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)', 'description': "Potential changes in participants' knowledge of gonorrhea, chlamydia, and syphilis will be assessed by comparing responses to the same set of 22 items included in the baseline survey and the satisfaction survey. Response values will be summed to obtain separate total scores ranging from 0-22, with higher scores indicating greater STI-related knowledge. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 67 participants who answered the questions assessing knowledge of gonorrhea, chlamydia, and syphilis in the baseline survey and the satisfaction survey'}, {'type': 'SECONDARY', 'title': 'Likelihood of Testing for Bacterial STIs at Least Annually', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '4.91', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' likelihood of testing for bacterial STIs at least annually will be assessed using a single 5-point Likert item included in the satisfaction survey. Response values will range from 1-5, with higher values indicating greater likelihood of testing for bacterial STIs at least annually.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 70 participants who answered the question on likelihood of testing for bacterial STIs at least annually'}, {'type': 'SECONDARY', 'title': 'Change in Self-efficacy for Specimen Self-collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'title': 'Pre-intervention score (from the baseline survey)', 'categories': [{'measurements': [{'value': '18.83', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention score (from the satisfaction survey)', 'categories': [{'measurements': [{'value': '17.54', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Difference', 'categories': [{'measurements': [{'value': '-1.29', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.29', 'pValueComment': 'A priori threshold for statistical significance = 0.05', 'estimateComment': 'Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)', 'groupDescription': 'Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0', 'statisticalMethod': 'Paired sample t-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Degrees of freedom = 47', 'nonInferiorityComment': 'Paired sample t-test, 2 sided'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)', 'description': "Potential changes in participants' self-efficacy for urine sample collection, throat swab collection, rectal swab collection, and blood sample collection will be assessed by comparing responses to similar sets of four 5-point Likert items included in the baseline survey and the satisfaction survey. Response values will be summed to obtain separate total scores ranging from 4-20, with higher scores indicating greater self-efficacy for specimen self-collection. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 48 participants who answered the questions assessing self-efficacy for urine sample collection, throat swab collection, rectal swab collection, and blood sample collection in the baseline survey and the satisfaction survey'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'title': 'Gonorrhea PCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Unable to Analyze Specimen', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chlamydia PCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Unable to Analyze Specimen', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Syphilis RPR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Unable to Analyze Specimen', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 16 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 57 participants who returned at least one type of specimen after receiving the specimen self-collection box'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 weeks after participants complete the baseline survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only includes 24 participants who tested positive for gonorrhea, chlamydia, or syphilis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were recruited between April 2024 and October 2024 via advertising on mobile dating apps and social networking sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Telehealth Intervention', 'description': 'Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.91', 'spread': '11.46', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-30', 'size': 426392, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-12T11:17', 'hasProtocol': True}, {'date': '2024-04-30', 'size': 277058, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-12T11:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2023-10-20', 'resultsFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-12', 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Schedule a Pre-test Session', 'timeFrame': 'Up to 8 weeks after participants complete the baseline survey'}, {'measure': 'Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time', 'timeFrame': 'Up to 8 weeks after participants complete the baseline survey'}, {'measure': 'Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery', 'timeFrame': 'Up to 16 weeks after participants complete the baseline survey'}, {'measure': 'Number of Participants That Provide Specimens of Adequate Quality for Lab Testing', 'timeFrame': 'Up to 16 weeks after participants complete the baseline survey'}, {'measure': 'Number of Participants That Schedule a Post-test Session', 'timeFrame': 'Up to 24 weeks after participants complete the baseline survey'}, {'measure': 'Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time', 'timeFrame': 'Up to 24 weeks after participants complete the baseline survey'}, {'measure': 'Overall Intervention Satisfaction', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' satisfaction with the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater overall intervention satisfaction."}, {'measure': 'Interventionist Perceptions', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' perceptions of the interventionist conducting the pre-test and the post-test sessions will be assessed using two 12-item Counselor Rating Form Short scales included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 24-168, with higher scores indicating more positive interventionist perceptions."}, {'measure': 'Usability of the Pre-test and the Post-test Sessions', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' usability of the pre-test and the post-test sessions will be assessed using two 4-item subscales from the Telehealth Usability Questionnaire on the quality of interactions with the interventionist during each session included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 8-56, with higher scores indicating greater usability of the pre-test and the post-test sessions."}, {'measure': 'Willingness to Repeat the Intervention', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' willingness to repeat the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater willingness to repeat the intervention."}, {'measure': 'Likelihood of Recommending the Intervention to Friends or Sex Partners', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' likelihood of recommending the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session to friends or sex partners will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater likelihood of recommending the intervention to friends or sex partners."}], 'secondaryOutcomes': [{'measure': 'Change in STI-related Knowledge', 'timeFrame': 'Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)', 'description': "Potential changes in participants' knowledge of gonorrhea, chlamydia, and syphilis will be assessed by comparing responses to the same set of 22 items included in the baseline survey and the satisfaction survey. Response values will be summed to obtain separate total scores ranging from 0-22, with higher scores indicating greater STI-related knowledge. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease."}, {'measure': 'Likelihood of Testing for Bacterial STIs at Least Annually', 'timeFrame': 'Up to 32 weeks after participants complete the baseline survey', 'description': "Participants' likelihood of testing for bacterial STIs at least annually will be assessed using a single 5-point Likert item included in the satisfaction survey. Response values will range from 1-5, with higher values indicating greater likelihood of testing for bacterial STIs at least annually."}, {'measure': 'Change in Self-efficacy for Specimen Self-collection', 'timeFrame': 'Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)', 'description': "Potential changes in participants' self-efficacy for urine sample collection, throat swab collection, rectal swab collection, and blood sample collection will be assessed by comparing responses to similar sets of four 5-point Likert items included in the baseline survey and the satisfaction survey. Response values will be summed to obtain separate total scores ranging from 4-20, with higher scores indicating greater self-efficacy for specimen self-collection. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease."}, {'measure': 'Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis', 'timeFrame': 'Up to 16 weeks after participants complete the baseline survey'}, {'measure': 'Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result', 'timeFrame': 'Up to 28 weeks after participants complete the baseline survey'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Specimen Collection', 'Audio/Video Conferencing', 'Motivational Interviewing', 'Sexual and Gender Minorities', 'Telemedicine'], 'conditions': ['Sexually Transmitted Diseases', 'Gonorrhea', 'Chlamydia', 'Syphilis', 'HIV']}, 'referencesModule': {'references': [{'pmid': '39208425', 'type': 'DERIVED', 'citation': 'Sharma A, Boyd S, Bonar EE. Feasibility and Acceptability of a Motivational Interviewing-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening: Protocol for a Sequential Explanatory Mixed Methods Study. JMIR Res Protoc. 2024 Aug 29;13:e64433. doi: 10.2196/64433.'}]}, 'descriptionModule': {'briefSummary': 'In the United States (US), gay and bisexual men living with human immunodeficiency virus (HIV) bear a heavy burden of bacterial sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis. It is important to diagnose and treat STIs in a timely manner to prevent health complications and reduce transmissions. The purpose of this study is to understand whether gay and bisexual men living with HIV are willing to collect and return specimens for bacterial STI testing when combined with live audio/video (AV) conferencing support.', 'detailedDescription': 'Participants will be recruited from across the US via social media advertising and peer referral. Seventy-five participants that complete an online survey (called the baseline survey) will be asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, attend a post-test live AV conferencing session, and complete another online survey (called the satisfaction survey). Some participants (20 of 75) will also be invited to attend an online interview to share study-related experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Individual self-reports identifying as a man (regardless of sex assigned at birth)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual self-reports identifying as a man (regardless of sex assigned at birth) in the eligibility screener\n* Individual self-reports residing in a US state or territory in the eligibility screener\n* Individual self-reports being physically located in a US state or territory when completing study activities in the eligibility screener\n* Individual self-reports being greater than or equal to (≥)18 years of age in the eligibility screener\n* Individual self-reports being of legal age to provide consent for research participation in the US state or territory of residence in the eligibility screener\n* Individual self-reports having been diagnosed with HIV in the eligibility screener\n* Individual self-reports having any kind of condomless sex (e.g., oral, anal) with ≥2 men in the past year in the eligibility screener\n* Individual self-reports being willing to provide contact information (full name, email address, mobile phone number, and mailing address) in the eligibility screener\n* Individual self-reports being able to participate in live AV conferencing sessions using an internet-connected device (e.g., computer, tablet, smartphone) in the eligibility screener\n* Individual self-reports being willing to receive a box that contains kits to self-collect a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing in the eligibility screener\n* Individual provides valid contact information (full name, email address, mobile phone number, and mailing address) in the contact information form\n* Individual completes the baseline survey in order to receive the intervention\n\nExclusion Criteria:\n\n* Individual self-reports not identifying as a man (regardless of sex assigned at birth) in the eligibility screener\n* Individual self-reports not residing in a US state or territory in the eligibility screener\n* Individual self-reports not being physically located in a US state or territory when completing study activities in the eligibility screener\n* Individual self-reports not being ≥18 years of age in the eligibility screener\n* Individual self-reports not being of legal age to provide consent for research participation in the US state or territory of residence in the eligibility screener\n* Individual self-reports not having been diagnosed with HIV in the eligibility screener\n* Individual self-reports not having any kind of condomless sex (e.g., oral, anal) with ≥2 men in the past year in the eligibility screener\n* Individual self-reports not being willing to provide contact information (full name, email address, mobile phone number, and mailing address) in the eligibility screener\n* Individual self-reports not being able to participate in live AV conferencing sessions using an internet-connected device (e.g., computer, tablet, smartphone) in the eligibility screener\n* Individual self-reports not being willing to receive a box that contains kits to self-collect a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing in the eligibility screener\n* Individual does not provide valid contact information (full name, email address, mobile phone number, and mailing address) in the contact information form\n* Individual does not complete the baseline survey in order to receive the intervention'}, 'identificationModule': {'nctId': 'NCT06100250', 'briefTitle': 'Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening', 'orgStudyIdInfo': {'id': 'HUM00240181'}, 'secondaryIdInfos': [{'id': '1R21AI168606-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21AI168606-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth intervention', 'description': 'Participants will receive an MI-based telehealth intervention for bacterial STI screening.', 'interventionNames': ['Behavioral: Motivational interviewing and specimen self-collection']}], 'interventions': [{'name': 'Motivational interviewing and specimen self-collection', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session.', 'armGroupLabels': ['Telehealth intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Akshay Sharma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'url': 'https://www.icpsr.umich.edu/web/pages/', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be made available within 6 months after analyses relating to the major aims of the proposed study have been completed and reported, and will remain available for at least 5 years.', 'ipdSharing': 'YES', 'description': 'Study results will be publicly reported through presentations at domestic and international conferences, and publications in peer-reviewed journals. Once analyses relating to the major aims of the proposed study have been completed and reported, the data will be deposited with the Inter-university Consortium for Political and Social Research (ICPSR) located at the University of Michigan. All confidentiality requirements will be followed as outlined on the website. ICPSR will make the data available to over 750 universities, government agencies, and other institutions, permitting other researchers to conduct secondary analyses. Data availability will be announced on the ICPSR website.', 'accessCriteria': 'Creating an account on the ICPSR website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, University of Michigan School of Nursing', 'investigatorFullName': 'Akshay Sharma', 'investigatorAffiliation': 'University of Michigan'}}}}