Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 11:04 PM
Study NCT ID:
NCT04430257
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2020-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-exposure Prophylaxis (PrEP) for Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069078', 'term': 'Seroconversion'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D062526', 'term': 'Patient Navigation'}, {'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D055633', 'term': 'Immune System Phenomena'}, {'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'}, {'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Individuals collecting the primary outcome data will be blinded to intervention condition.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP uptake', 'timeFrame': '3 months', 'description': 'PrEP uptake will be assessed via medical/pharmacy records'}, {'measure': 'Post-treatment PrEP adherence', 'timeFrame': '3 months', 'description': 'PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)'}], 'secondaryOutcomes': [{'measure': 'Longer-term PrEP adherence', 'timeFrame': '6 and 12 months', 'description': 'Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP (pre-exposure prophylaxis )', 'PWID (people who inject drugs)', 'SSP (syringe service program)', 'HIV education', 'Motivational interviewing', 'Self efficacy', 'Social cognitive theory'], 'conditions': ['Substance Dependence', 'HIV (Human Immunodeficiency Virus)']}, 'referencesModule': {'references': [{'pmid': '36932369', 'type': 'DERIVED', 'citation': 'Bazzi AR, Bordeu M, Baumgartner K, Sproesser DM, Bositis CM, Krakower DS, Mimiaga MJ, Biello KB. Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs. BMC Public Health. 2023 Mar 17;23(1):513. doi: 10.1186/s12889-023-15429-w.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.', 'detailedDescription': 'The overall goal of this proposal is to evaluate the efficacy of the "PrEP for Health" navigator delivered behavioral intervention in improving PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) among PWID in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12 months after randomization.\n\nWe hypothesize that brief, multi-component behavioral intervention sessions with ongoing support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP knowledge (including alleviating concerns about side effects), increasing HIV risk perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral skills, and reducing structural barriers over time. Based on our formative research, we also hypothesize that the strength of intervention effects may differ by key individual characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use).\n\nThis is a randomized control trial (RCT). Participants will be recruited via outreach specialist at SSP sites and during routine community outreach practices of the organizations. After eligibility confirmation and baseline assessments, participants will be randomized to one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided through the SSP study sites, participants will receive information and services according to routine practice and a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission; 2) "PrEP for Health" Intervention Condition: a trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support through in-person, phone, and text interactions as needed. Participants will complete a total of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid HIV screening test at 12-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-uninfected (verified by rapid/4th generation test)\n* Reporting past-month injection of any drugs\n* One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)\n* Not currently on and never taken PrEP\n* Able to understand and speak English or Spanish\n\nExclusion Criteria:\n\n* Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment\n* Living in Massachusetts (MA) for \\<3 months\n* Planning to move out of MA within a year'}, 'identificationModule': {'nctId': 'NCT04430257', 'acronym': 'PrEP', 'briefTitle': 'Pre-exposure Prophylaxis (PrEP) for Health', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast', 'orgStudyIdInfo': {'id': '2011002841'}, 'secondaryIdInfos': [{'id': 'R01DA051849-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DA051849-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrEP for health', 'description': 'Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.', 'interventionNames': ['Other: HIV and PrEP education', 'Behavioral: Motivational interviewing', 'Behavioral: Problem-solving and planning', 'Behavioral: Patient navigation', 'Other: PrEP information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Participants in the standard of care arm will receive PrEP information and referrals.', 'interventionNames': ['Other: PrEP information', 'Other: Referrals']}], 'interventions': [{'name': 'HIV and PrEP education', 'type': 'OTHER', 'description': 'Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.', 'armGroupLabels': ['PrEP for health']}, {'name': 'Motivational interviewing', 'type': 'BEHAVIORAL', 'description': 'Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.', 'armGroupLabels': ['PrEP for health']}, {'name': 'Problem-solving and planning', 'type': 'BEHAVIORAL', 'description': 'Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.', 'armGroupLabels': ['PrEP for health']}, {'name': 'Patient navigation', 'type': 'BEHAVIORAL', 'description': "Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites", 'armGroupLabels': ['PrEP for health']}, {'name': 'PrEP information', 'type': 'OTHER', 'description': 'A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.', 'armGroupLabels': ['PrEP for health', 'Standard of care']}, {'name': 'Referrals', 'type': 'OTHER', 'description': 'Study staff will provide basic information about PrEP and referrals to PrEP clinicians.', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02139', 'city': 'Cambridge', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cassidy Ockene', 'role': 'CONTACT', 'email': 'cockene@fenwayhealth.org', 'phone': '6179276286'}, {'name': 'Michelle Bordeu, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AIDS Action', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '01841', 'city': 'Lawrence', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Bositis, MD', 'role': 'CONTACT', 'email': 'cbositis@glfhc.org', 'phone': '978-689-6444'}, {'name': 'Christopher Bositis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Katrina Baumgartner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Greater Lawrence Family Health Center', 'geoPoint': {'lat': 42.70704, 'lon': -71.16311}}], 'centralContacts': [{'name': 'Katie Biello, PhD, MPH', 'role': 'CONTACT', 'email': 'katie_biello@brown.edu', 'phone': '401-863-6551'}, {'name': 'Angela Bazzi, PhD', 'role': 'CONTACT', 'email': 'abazzi@health.ucsd.edu'}], 'overallOfficials': [{'name': 'Katie Biello, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}, {'name': 'Angela Bazzi, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available after the study has closed and after publication of the primary study findings.', 'ipdSharing': 'YES', 'description': 'By request to the study investigators', 'accessCriteria': 'Requests will be reviewed by the principal investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'The Fenway Institute', 'class': 'OTHER'}, {'name': 'AIDS Action Committee of Massachusetts', 'class': 'OTHER'}, {'name': 'Greater Lawrence Family Health Center', 'class': 'UNKNOWN'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}