Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-29 @ 3:43 PM
Study NCT ID:
NCT06934395
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHARE Program: SUSTAIN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ART Adherence', 'timeFrame': 'Daily for 56 Days', 'description': 'Antiretroviral (ART) adherence will be assessed daily using an Ecological Momentary Assessment (EMA) survey delivered via SMS. Individuals will be asked whether they took some or all of their medication.'}], 'secondaryOutcomes': [{'measure': 'Alcohol Use', 'timeFrame': 'Baseline, 3 month, and 6 month', 'description': 'Alcohol will be assessed using the Timeline Followback (TLFB) measure to capture amount of drinking over a 30 day period, assessed at baseline, and at the 3 and 6 month follow-ups. Participants complete a 30 day calendar that assesses number of drinks per day and number of hours spent drinking per drinking day.'}, {'measure': 'HIV Viral Load', 'timeFrame': 'Baseline, 3 month, and 6 month', 'description': "HIV Viral Load collected via Dried Blood Spot (DBS) kits. The limit of detection (LOD) of the m2000 test is 832 copies/mL or Log 2.92 copies/mL. For samples with VL above the LOD (\\>Log 2.92) can be quantified so a VL is provided. In case of samples with less than LOD is given as \\<2.92 but it's reported as detected as the presence of HIV virus is detected but cannot be quantified as it's below the LOD so cannot be measured. And samples that are not detected are reported as 'not detected.'"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiv']}, 'descriptionModule': {'briefSummary': 'The goal of PROJECT SUSTAIN is to optimize Healthy Choices to advance an adaptive and scalable intervention designed to improve self-management of alcohol and HIV in Young People with HIV (YPWH) while understanding the context for state-wide implementation and sustainment in a Hybrid Experimental Design (HED). SUSTAIN utilizes mHealth and telehealth intervention delivery of Healthy Choices (HC), combined with text messaging between sessions, to increase the likelihood of daily medication adherence (primary outcome), and increase the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (secondary outcome).', 'detailedDescription': 'Primary aim: To test whether, on average, delivering (vs. not delivering) a text messaged prompt focused on medication adherence or stress increases the likelihood of medication adherence by the end of the current day.\n\nSecondary aim: To test whether offering (vs. not offering) a Healthy Choices telehealth coaching session at the end of week 2 (day 14) increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3.\n\nImplementation Aim: Assess barriers and facilitators to the implementation and sustainment of intervention sequences for state-wide scale up using mixed methods (EPIS qualitative interviews, youth satisfaction and dose received, fidelity for telehealth, paradata for mHealth, and cost-effectiveness analysis).\n\nCross-project Moderator Aim: Explore age, biological sex and gender, ethnicity, other substance use, and mental health as moderators of intervention effects.\n\nPrimary hypothesis to be tested: Delivering (vs. not delivering) a text messaged prompt will lead to greater likelihood of medication adherence by the end of the current day.\n\nSecondary hypothesis to be tested: Offering a Healthy Choices telehealth coaching at the end of week 2 will lead to greater likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (post-intervention) compared to not offering a Healthy Choices telehealth coaching session at the end of week 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be 18 years and 0 months to 29 years and 11 months.\n* Currently reside in Florida\n* History of alcohol use\n* Are not pregnant nor trying to conceive within the study's timeline\n* Are able to read and understand English\n* Have internet access via smartphone, tablet or computer\n* Are willing to provide informed consent.\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Prisoners\n* Those using long-acting injectables as HIV medication regimen"}, 'identificationModule': {'nctId': 'NCT06934395', 'briefTitle': 'SHARE Program: SUSTAIN', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults', 'orgStudyIdInfo': {'id': 'STUDY00002536'}, 'secondaryIdInfos': [{'id': '5P01AA029547', 'link': 'https://reporter.nih.gov/quickSearch/5P01AA029547', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Within-participant micro-randomization - Prompt', 'description': 'Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.', 'interventionNames': ['Behavioral: Text Message Prompts']}, {'type': 'NO_INTERVENTION', 'label': 'Within-participant micro-randomization - No Prompt', 'description': 'Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress.'}, {'type': 'EXPERIMENTAL', 'label': 'Between-participant randomization - CIAS + Week 2 Coaching Session', 'description': 'Participants will be randomized at the end of week 2 (day 14) to receive the Healthy Choices telehealth intervention with trained interventionist at week 2.\n\nAll enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).', 'interventionNames': ['Behavioral: Healthy Choices']}, {'type': 'NO_INTERVENTION', 'label': 'Between-participant randomization - CIAS + No Week 2 Coaching Session', 'description': 'Participants will be randomized at the end of week 2 (day 14) to NOT receive the Healthy Choices telehealth intervention with trained interventionist at week 2.\n\nAll enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).'}], 'interventions': [{'name': 'Healthy Choices', 'type': 'BEHAVIORAL', 'description': "Healthy Choices is an adapted and developmentally tailored intervention designed to address self-management of risk behaviors and HIV from Motivational Enhancement Therapy, a brief alcohol intervention in SAMHSA's registry of evidenced-based programs. For the purposes of this project, this intervention will be delivered as a combination approach, with all participants receiving an initial session via CIAS, and randomized to either receiving a telehealth session with a trained interventionist at week 2, with additional randomizations for telehealth sessions at weeks 4 and 6. The goal is to test if delivering (vs. not delivering) a coaching session increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3", 'armGroupLabels': ['Between-participant randomization - CIAS + Week 2 Coaching Session']}, {'name': 'Text Message Prompts', 'type': 'BEHAVIORAL', 'description': 'This within-participant micro-randomization will test whether, on average, delivering (vs. not delivering) a text messaged prompt focused on medication adherence or stress increases the likelihood of medication adherence by the end of the current day .', 'armGroupLabels': ['Within-participant micro-randomization - Prompt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32310', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen MacDonell, PhD', 'role': 'CONTACT', 'email': 'karen.macdonell@med.fsu.edu'}, {'name': 'Sara Green, MSW', 'role': 'CONTACT', 'email': 'sara.green@med.fsu.edu', 'phone': '850-644-2334'}], 'facility': 'Florida State University, Center for Translational Behavioral Science', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Northeastern University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Karen MacDonell, PhD', 'role': 'CONTACT', 'email': 'karen.macdonell@med.fsu.edu', 'phone': '850-644-2334'}, {'name': 'Sara Green, MSW', 'role': 'CONTACT', 'email': 'sara.green@med.fsu.edu', 'phone': '8506442334'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'Northeastern University', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'University of South Florida', 'class': 'OTHER'}, {'name': 'CAN Community Health', 'class': 'OTHER'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sylvie Naar', 'investigatorAffiliation': 'Florida State University'}}}}