Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-08 @ 11:20 AM
Study NCT ID:
NCT02378766
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Web-based Interventions to Support People Living With HIV in the Adoption of Health Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tobacco smoking', 'timeFrame': '6 months', 'description': 'Measured with a single question: "In the past 7 days, have you had a smoke or even just a single puff? (0=no/1=yes)". Compared to biochemical verification (urinary cotinine test), this self-report measure has a sensitivity of 96.9% and a specificity of 93.4% (Noonan, Jiang et al. 2013) and it correlates well with biochemical validation (Velicer, Prochaska et al. 1992).'}, {'measure': 'Change in level of physical activity', 'timeFrame': '6 months', 'description': 'The level of physical activity will be measured through the adaptation of a procedure elaborated and validated by Godin and al. (1985, 1986). Participants will indicate, during a typical week and for each level of intensity (high, moderate, low), the frequency and the mean duration of physical activity practice.'}, {'measure': 'Change in diet quality', 'timeFrame': '6 months', 'description': 'Measured with the brief tool Starting The Conversation an 8-item simplified food frequency instrument (Paxton, Strycker et al. 2011) derived from a validated 54-item instrument (Jilcott, Keyserling et al. 2007). Item scores are tallied for an overall score (range of 0-16). STC is stable over time and sensitive to treatment/intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in Intention regarding the adoption of the chosen health behaviour', 'timeFrame': '6 months', 'description': 'Intention is assessed by three items: 1) "I intend to (a: stop smoking, b: do more physical activity, c: make better choices regarding fat in my diet)" rated on a scale from 1 = strongly disagree to 5 = strongly agree; 2) "I will (a, b or c)" rated on a scale from 1 = very unlikely to 5 = very likely; 3) "the chances that I will (a, b or c) are…" rated on a scale from 1 = very low to 5 = very high. Intention item scores are tallied for an overall score (range of 3-15).'}, {'measure': 'Change in perceived control regarding the adoption of the chosen health behaviour', 'timeFrame': '6 months', 'description': 'Perceived control is assessed by three items : 1) "I feel that I will be able to (a: stop smoking, b: do more physical activity, c: make better choices regarding fat in my diet)" rated on a scale from 1 = strongly disagree to 5 = strongly agree; 2) "I am confident that I will succeed in (a, b or c)" rated on a scale from 1 = strongly disagree to 5 = strongly agree; 3) "how much control do you have over (a, b or c)?" rated on a scale from 1 = strongly uncontrollable to 5 = strongly controllable. Perceived control item scores are tallied for an overall score (range of 3-15).'}, {'measure': 'Change in attitude regarding the adoption of the chosen health behaviour', 'timeFrame': '6 months', 'description': 'Attitude is measured by asking participants to respond-using five 5-point adjective pairs (unpleasant/pleasant, useless/useful, bad/good, unsatisfying/satisfying, boring/interesting) to the statement linked to their chosen behavior, "Smoking cessation would be for me…" or "Doing more physical activity would be for me…" or "Making better choices regarding fat in my diet would be for me…". Attitude item scores are tallied for an overall score (range of 5-25).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tailored web-based intervention', 'health behavior', 'hiv comorbidities', 'online trial'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '26458508', 'type': 'BACKGROUND', 'citation': 'Cote J, Cossette S, Ramirez-Garcia P, De Pokomandy A, Worthington C, Gagnon MP, Auger P, Boudreau F, Miranda J, Gueheneuc YG, Tremblay C. Evaluation of a Web-based tailored intervention (TAVIE en sante) to support people living with HIV in the adoption of health promoting behaviours: an online randomized controlled trial protocol. BMC Public Health. 2015 Oct 12;15:1042. doi: 10.1186/s12889-015-2310-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of a web-based tailored intervention to support persons living with HIV (PLHIV) manage the demands inherent to their health condition, particularly as regards to the adoption of health behaviours such as being physically active, following a healthy diet and quitting smoking.\n\nThis randomized controlled trial is currently conducted entirely online at www.lhivehealthy.ca', 'detailedDescription': "This online randomized controlled trial with parallel-groups is conducted across Canada. Interested participants are invited to visit the study's Website at www.lhivehealthy.ca\n\nThe study's Website contains video clips explaining the study. After accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.\n\nAfter completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (TAVIE en santé) or to a control group (list of 5 websites).\n\nThree and six months after the baseline questionnaire, participants will complete the online questionnaires again."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be living with HIV\n* to be able to read and understand French or English\n* to have access to the Internet'}, 'identificationModule': {'nctId': 'NCT02378766', 'acronym': 'LHIVEHEALTHY', 'briefTitle': 'Evaluation of Web-based Interventions to Support People Living With HIV in the Adoption of Health Behaviors', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Evaluation of a Tailored Virtual Intervention as an Instrument of Prevention and Support to Improve the Health of PLHIV and Reduce Comorbidity Associated With HIV (MP-02-2015-5853)', 'orgStudyIdInfo': {'id': 'CE 14.342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Website A', 'description': 'Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé.', 'interventionNames': ['Behavioral: Website A']}, {'type': 'OTHER', 'label': 'Website B', 'description': 'Patients assigned to this arm will be invited to consult a validated list of five predetermined websites.', 'interventionNames': ['Other: Website B']}], 'interventions': [{'name': 'Website A', 'type': 'BEHAVIORAL', 'description': 'Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé (TAVIE : Traitement, Assistance Virtuelle Infirmière et Enseignement).\n\nTAVIE en santé is a web-based tailored multicomponent intervention addressing smoking cessation, physical activity and healthy eating. Each component consists of seven interactive computer sessions lasting 5-10 minutes. The sessions, hosted by a virtual nurse, aims to develop and strengthen skills required for behavior change.', 'armGroupLabels': ['Website A']}, {'name': 'Website B', 'type': 'OTHER', 'description': 'Patients assigned to this arm will be invited to consult a validated list of five predetermined websites offering information about the health behavior they chose: being physically active, following a healthy diet or quitting smoking. These websites offers reliable information and their content were validated by experts.', 'armGroupLabels': ['Website B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Sylvie Cosette, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cardiologie de Montréal'}, {'name': 'Cécile Tremblay, Md, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CR-CHUM'}, {'name': 'Michal Abrahamowicz, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'McGill University'}, {'name': 'François Boudreau, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Université du Québec à Trois-Rivièves'}, {'name': 'Jean-Louis Chiasson, Md', 'role': 'STUDY_CHAIR', 'affiliation': 'CR-CHUM'}, {'name': 'Alexandra De Pokomandy, Md', 'role': 'STUDY_CHAIR', 'affiliation': 'CUSM'}, {'name': 'Marie-Pierre Gagnon, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Laval University'}, {'name': 'Yann-Gaël Guéhéneuc, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'École Polytechnique de Montréal'}, {'name': 'Joyal Miranda, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto Metropolitan University'}, {'name': 'Pilar Ramirez-Garcia, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Université de Montréal'}, {'name': 'Catherine Worthington, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Victoria'}, {'name': 'José Côté, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CR-CHUM, Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'CIHR Canadian HIV Trials Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}