Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-12 @ 5:35 PM
Study NCT ID:
NCT02004457
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Engaging HIV Patients in Primary Care by Promoting Acceptance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of attended primary care medical appointments', 'timeFrame': '9 months', 'description': 'The number of primary care medical appointments a participant attends over the course of 9 months.'}, {'measure': 'Acceptance and Action Questionnaire-2', 'timeFrame': '9 months', 'description': 'A modified version of the Acceptance and Action Questionnaire-2 (AAQ-2) will be used to quantify the degree to which participants accept their HIV diagnosis and related stresses.'}, {'measure': 'HIV Disclosure Scale', 'timeFrame': '9 months', 'description': 'The HIV Disclosure Scale will be used to quantify how willing participants are to disclose their HIV status to others.'}], 'secondaryOutcomes': [{'measure': 'Berger HIV Stigma Scale', 'timeFrame': '9 months', 'description': 'The Berger HIV Stigma Scale will used to measure the degree to which participants experience HIV-related stigma.'}, {'measure': 'Disclosure to others', 'timeFrame': '9 months', 'description': 'The number of individuals to whom the participant discloses his/her HIV status to.'}, {'measure': 'Social Support Questionnaire', 'timeFrame': '9 months', 'description': "The Social Support Questionnaire will be used to measure participants' perceived social support."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Primary care', 'Engagement', 'Acceptance', 'Disclosure', 'Stigma'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '28451891', 'type': 'DERIVED', 'citation': 'Moitra E, LaPlante A, Armstrong ML, Chan PA, Stein MD. Pilot Randomized Controlled Trial of Acceptance-Based Behavior Therapy to Promote HIV Acceptance, HIV Disclosure, and Retention in Medical Care. AIDS Behav. 2017 Sep;21(9):2641-2649. doi: 10.1007/s10461-017-1780-z.'}]}, 'descriptionModule': {'briefSummary': 'Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public health concern because reduced commitment to care puts PLWHA at risk for illness progression, death, and transmission of HIV to others. This project will develop a novel treatment, brief acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a pathway to reducing engagement barriers. The clinical and public health impact of this project will be the development of a simple, low-cost, disseminable intervention that enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments that will prolong survival and improve quality of life. We hypothesize that individuals randomized to brief ABBT will showed increased longitudinal attendance of primary care appointments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new to the primary care clinic\n* HIV+\n* between 18 and 60 years old\n* entering HIV care for the first time\n* able to speak and read English sufficiently to be able to complete the study procedures\n* have access to a telephone\n\nExclusion Criteria:\n\n* psychiatrically or cognitively impaired'}, 'identificationModule': {'nctId': 'NCT02004457', 'acronym': 'HIV Engage', 'briefTitle': 'Engaging HIV Patients in Primary Care by Promoting Acceptance', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Engaging HIV Patients in Primary Care by Promoting Acceptance', 'orgStudyIdInfo': {'id': 'R34MH098694-02', 'link': 'https://reporter.nih.gov/quickSearch/R34MH098694-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance-based behavior therapy (ABBT)', 'description': "ABBT will consist of 2 sessions. The first session will be used to introduce the concept of acceptance and its possible benefits in the context of life values and patient-identified barriers to care engagement. Following a discussion of life values will be a discussion of which, if any, of these values are currently misaligned with the participant's HIV self-care. At the second session, acceptance-based coping skills will be practiced and a behavioral plan will be developed to targets barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage his/her HIV (e.g. when and how to disclose, what to expect at appointments).", 'interventionNames': ['Behavioral: ABBT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment-as-usual (TAU)', 'description': 'TAU will consist of the standard sessions all individuals receive as they enter HIV care and attend their first follow-up visit to review lab results. TAU includes identification of environmental barriers to care, assessment of needs for additional care and corresponding referrals (i.e., for depression, substance abuse), and recommendations to attend HIV support groups.', 'interventionNames': ['Other: TAU']}], 'interventions': [{'name': 'ABBT', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Acceptance-based behavior therapy (ABBT)']}, {'name': 'TAU', 'type': 'OTHER', 'armGroupLabels': ['Treatment-as-usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}