Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 1:10 PM
Study NCT ID:
NCT05829759
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2023-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Delivery (Tele-B6)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-23', 'releaseDate': '2025-12-08'}], 'estimatedResultsFirstSubmitDate': '2025-12-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}, {'id': 'D001727', 'term': 'Bisexuality'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-16', 'size': 350205, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-22T15:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2025-11-03', 'completionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2023-04-13', 'dispFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in HIV viral load', 'timeFrame': '0 and 6 months', 'description': 'The research team will review the electronic medical record (EMR) to abstract HIV viral load information'}, {'measure': 'Rate of retention care', 'timeFrame': '0 and 6 months', 'description': 'The research team will review the electronic medical record (EMR) to abstract data on missed appointments'}], 'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': 'Study Exit (up to 8* months)', 'description': 'Qualitative interviews: Open-ended questions adapted from the original B6 exit interview guide.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in the Acceptability Surveys', 'timeFrame': '2, 4, 6, up to 8* months', 'description': 'Post-session evaluation forms (adapted from original B6) after each group session.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in Recruitment Rates', 'timeFrame': '2, 4, 6, up to 8* months', 'description': 'Rates of participation from screened and eligible participants.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in retention', 'timeFrame': '2, 4, 6, up to 8* months', 'description': 'Attendance logs during each visit.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in the intervention fidelity', 'timeFrame': '2, 4, 6, up to 8* months', 'description': 'Review of the Structured intervention logs (adapted from original B6)\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Safety (adverse events)', 'timeFrame': 'During study participation up to 8* months', 'description': 'Review of Adverse event tracking forms\n\n\\*8-month timepoint only applies to waitlist control participants'}], 'secondaryOutcomes': [{'measure': 'Change in Perception of Structural Racism and Discrimination.', 'timeFrame': '0, 2, 4, 6, 8* months', 'description': "Participants will complete surveys measuring socioeconomic status, material resources scale. The material resources survey has 18 questions asking how often the participants' family needs are adequately met. There are six options (never=0; rarely=1; less than half of the time=w, about half of the time=3; more than half of the time=4; and always=5). The highest score means that needs are adequately met.\n\n\\*8-month timepoint only applies to waitlist control participants"}, {'measure': 'Change in Perception of discrimination', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': "Participants will complete the Everyday Discrimination Scale at baseline and after each session. Each response is given a value according to the Likert scale ('never'=1 to 'almost everyday'=6). Responses are summed across items to produce a score ranging from 10 to 60. A higher score may indicate higher perception of discrimination.\n\n\\*8-month timepoint only applies to waitlist control participants"}, {'measure': 'Change in Perception of HIV stigma', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': 'Participants will complete the HIV stigma scale at baseline and after each session. This scale includes which includes 10 item stigma rated on a 5-point scale from "Strongly Disagree" to "Strongly Agree".\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in Perception of internalized homonegativity inventory', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': 'Participants will complete the internalized homonegativity inventory at baseline and after each session.\n\nThis 26-item scale has four subscales: (a) Public Identification as Gay, (b) Perception of Stigma Associated with Being Gay, (c) Social Comfort with Gay Men, (d) Moral and Religious Acceptability of Being Gay.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Qualitative description of intersectional stigma', 'timeFrame': 'Exit of study (up to 8 months)', 'description': 'Participants will be asked to complete surveys with open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in intersectional stigma', 'timeFrame': 'Exit of study (up to 8 months)', 'description': 'Participants will be asked to complete surveys with open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Change in logistical barriers', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': 'Participants will be asked to complete surveys and matched to Zipcode to derive neighborhood measures.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Qualitative description of logistical barriers', 'timeFrame': 'Exit of study (up to 8 months)', 'description': 'Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Changes in perception of individual resilience process: Identity Affirmation', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': 'Participants will complete the multidimensional model of black identity lesbian, gay, and bisexual identity scale,\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Qualitative description individual resilience process: Identity Affirmation', 'timeFrame': 'Exit of study (up to 8 months)', 'description': 'Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Changes in the community resilience process: social capital', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': 'Participants will complete the personal social capital scale. A five-point Likert scale is used to assess these questions with 1 = none and 5 = all. A composite score will be derived by summarizing the item scores such that a higher score indicates a greater perceived collective efficacy.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Qualitative description of the community resilience process: social capital', 'timeFrame': 'Exit of study (up to 8 months)', 'description': 'Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Changes in the perception of minority stress: depression', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': 'Participants will complete the Studies Depression Scale (CES-D) survey. In scoring the CES-D, a value of 0, 1, 2, or 3 is assigned to a response depending upon whether the item is worded positively or negatively. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.\n\n\\*8-month timepoint only applies to waitlist control participants'}, {'measure': 'Changes in the perception of minority stress: general well-being', 'timeFrame': '0, 2, 4, 6, up to 8* months', 'description': "Participants will complete the general well-being (GWB) survey. The General Well-Being Schedule (GWB) is designed to assess an individual's mental health or quality of life. The GWB consists of 18 items indicating subjective feelings of psychological well-being and distress. All of the items utilize the past month as the time frame of interest. The first 14 questions use a six-point rating scale that represents either intensity or frequency. The remaining items use a 0-10 rating scale that is anchored by adjectives. Because some items are reverse scored (items 1, 3, 6, 7, 9, 11, 15, and 16), 14 is subtracted from the total score, yielding a total possible range of scores from 0 to 110. Low scores represent greater distress. Proposed cutoffs representing three levels of distress are 0-60 (severe distress), 61-72 (moderate distress), and 73-110 (positive well-being).\n\n\\*8-month timepoint only applies to waitlist control participants"}, {'measure': 'Qualitative description of the minority stress', 'timeFrame': 'Exit of study (up to 8 months)', 'description': 'Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.\n\n\\*8-month timepoint only applies to waitlist control participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['black', 'Multiracial identity'], 'conditions': ['HIV Seropositivity', 'Bisexuality']}, 'referencesModule': {'references': [{'pmid': '41325601', 'type': 'DERIVED', 'citation': 'Reed MO, Bullock M, Newman A Jr, Dutta S, Opara SCO, Tewodros T, Doraivelu K, Camacho-Gonzalez A, Murden R, Gamarel K, Harper GW, Hussen SA. Brothers Building Brothers by Breaking Barriers: Protocol for a Pilot Trial of a Telehealth Social Capital Intervention for Young Black Sexual Minority Men Living With HIV. JMIR Res Protoc. 2025 Dec 1;14:e69961. doi: 10.2196/69961.'}]}, 'descriptionModule': {'briefSummary': 'The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.', 'detailedDescription': 'Subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over a six-week period. Sessions will include engaging educational components and interactive activities including discussions of case scenarios and sharing of personal experiences where desired. At the end of each videoconference session, participants will be asked to complete a brief session evaluation form in which they will rate the content, facilitation, and overall experience for the week. The long-term goal is to improve engagement across the HIV continuum of care (HIV-CoC) by enhancing individual- and community-level resilience processes among young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV. To this end, the research team has used community-based participatory research methods to develop Brothers Building Brothers by Breaking Barriers (B6), a novel group-level intervention designed to affirm intersectional identities and augment social capital among YB-GBMSM. The goal of this current study is to adapt and pilot B6 for telehealth delivery (creating tele-B6) within the context of an established community-based organization (CBO), as a strategy for enhancing feasibility and scalability prior to a larger efficacy trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male gender, inclusive of transgender men', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Black race, inclusive of multiracial identities; male gender, inclusive of transgender men;\n* self-identification as gay, bisexual, or another non-heterosexual orientation, and/or any history of consensual anal or oral sex with men;\n* HIV-positive serostatus;\n* age 18-29 years inclusive;\n* residence in the Atlanta Metropolitan Statistical Area;\n* available and interested to meet for two hours weekly over a six-week period.\n\nExclusion Criteria:\n\n* Age \\< 18 years or \\> 30 years\n* Unwilling or unable to provide written informed consent\n* Enrollment in one phase of the study is an exclusion criterion for enrollment in other phases'}, 'identificationModule': {'nctId': 'NCT05829759', 'briefTitle': 'Telehealth Delivery (Tele-B6)', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)', 'orgStudyIdInfo': {'id': 'STUDY00003404'}, 'secondaryIdInfos': [{'id': 'R34MH129187-01', 'link': 'https://reporter.nih.gov/quickSearch/R34MH129187-01', 'type': 'NIH'}, {'id': '2025P013132', 'type': 'OTHER', 'domain': 'Emory IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tele-B6', 'description': 'The tele-B6 intervention includes six group sessions delivered over the course of six weeks. Survey assessments for the intervention group will be conducted at enrollment (baseline), 2 months (immediate post-intervention survey), 4 months (interim-survey, post-intervention), and 6 months (endline).', 'interventionNames': ['Behavioral: Tele-B6']}, {'type': 'OTHER', 'label': 'Wait-list control -delayed intervention', 'description': 'Await-list control design to safeguard ethical treatment of participants by ensuring that a potentially impactful intervention will be available to all after a brief waiting period.', 'interventionNames': ['Behavioral: Delayed intervention (waitlist control)']}], 'interventions': [{'name': 'Tele-B6', 'type': 'BEHAVIORAL', 'description': 'Participants will be part of the Tele-B6 intervention that includes six group sessions delivered over the course of six weeks. Survey assessments for the intervention group (first phase) will be conducted at enrollment (baseline), 2 months (immediate post-intervention survey), 4 months (interim-survey, post-intervention), and 6 months (endline).', 'armGroupLabels': ['Tele-B6']}, {'name': 'Delayed intervention (waitlist control)', 'type': 'BEHAVIORAL', 'description': 'Wait-list control participants will be assigned to a group for initiation of the full intervention beginning at month 4 after their enrollment (i.e., beginning after they, and their corresponding intervention group, have completed their intervention and two follow-up surveys). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (preintervention), 6 months (immediate post-intervention), and 8 months (post-intervention).', 'armGroupLabels': ['Wait-list control -delayed intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Infectious Diseases Program Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Sophia A. Hussen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The de-identified dataset will be available after the study and data analysis are complete.', 'ipdSharing': 'YES', 'description': 'The research team will share the results of surveys and clinical abstracted data in a de-identified dataset.', 'accessCriteria': 'All requests should be sent by email to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Public Health and Medicine', 'investigatorFullName': 'Sophia Hussen', 'investigatorAffiliation': 'Emory University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-08', 'type': 'RELEASE'}, {'date': '2025-12-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sophia Hussen, Associate Professor of Public Health and Medicine, Emory University'}}}}