Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-27 @ 2:31 PM
Study NCT ID:
NCT04331704
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2020-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANCHORS Alcohol & Sexual Health Study: UH3 Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065129', 'term': 'Pre-Exposure Prophylaxis'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2020-03-27', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quantity of drinks per week', 'timeFrame': 'Baseline up to 1 and 6-month follow-up', 'description': 'Change in self-reported number of alcoholic drinks per week'}, {'measure': 'Change in peak drinking quantity', 'timeFrame': 'Baseline up to 1 and 6-month follow-up', 'description': "Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days"}, {'measure': 'PrEP levels in blood at end of intervention period', 'timeFrame': '1-month follow-up', 'description': 'Determine whether or not participants have therapeutic levels of PrEP in their blood samples'}, {'measure': 'PrEP levels in blood at the end of the follow-up period', 'timeFrame': '6-month follow-up', 'description': 'Determine whether or not participants have therapeutic levels of PrEP in their blood samples'}, {'measure': 'PrEP prescription fill with supporting documentation in the intervention period', 'timeFrame': 'during the 1-month intervention period', 'description': 'Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation'}, {'measure': 'PrEP prescription fills with supporting documentation during the follow-up period', 'timeFrame': 'the 6-month follow-up period', 'description': 'Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation'}], 'secondaryOutcomes': [{'measure': 'Reduced alcohol use as a reason for adherence to PrEP', 'timeFrame': 'Baseline up to 1 and 6-month follow-up', 'description': 'Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP'}, {'measure': 'Change in perceived risk of HIV as a reason for adherence to PrEP', 'timeFrame': 'Baseline up to 1 and 6-month follow-up', 'description': 'Test increase in Perceived Risk of HIV Scale score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP'}, {'measure': 'Change in sexual risk behavior as a reason for adherence to PrEP', 'timeFrame': 'Baseline up to 1 and 6-month follow-up', 'description': 'Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP'}, {'measure': 'Increased motivation for behavior change as a reason for adherence to PrEP', 'timeFrame': 'Baseline up to 1 and 6-month follow-up', 'description': 'Test increased score on the Contemplation Ladder for motivation to avoid risky sexual health behavior, to take PrEP and to reduce drinking following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use, Unspecified', 'Substance Use', 'Sex Behavior']}, 'descriptionModule': {'briefSummary': '80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days. Medication will all be active PrEP. There is no placebo control in this study. Follow-up will occur after 30-days and 6-months later.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male sex assigned at birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to read and write English\n* Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days\n* Sexual intercourse with another man without condom use at least once in the past 30 days\n* HIV seronegative at medical screening\n* Report currently taking PrEP willingness to take PrEP\n\nExclusion Criteria:\n\n* History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute Withdrawal Assessment scale score \\> 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; or d) a lifetime history of medical treatment for withdrawal.\n* Self report injection drug use\n* DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.\n* Serious psychiatric symptoms\n* Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or other drugs that may interfere with tenofovir excretion\n* Active hepatitis B infection\n* The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing\n* Participant reports currently taking injectable PrEP'}, 'identificationModule': {'nctId': 'NCT04331704', 'briefTitle': 'ANCHORS Alcohol & Sexual Health Study: UH3 Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project', 'orgStudyIdInfo': {'id': 'IRB201902818-N'}, 'secondaryIdInfos': [{'id': 'UH3AA026214', 'link': 'https://reporter.nih.gov/quickSearch/UH3AA026214', 'type': 'NIH'}, {'id': 'OCR31862', 'type': 'OTHER', 'domain': 'OnCore University of Florida'}, {'id': 'F31AA028751', 'link': 'https://reporter.nih.gov/quickSearch/F31AA028751', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized Information', 'description': 'Participants randomized to this condition will complete a web-based questionnaire and then receive personalized information regarding their alcohol use and sexual health behavior. They will complete daily, phone-based IVR monitoring for assessment purposes and receive further personalized information based on their responses.', 'interventionNames': ['Drug: PrEP acronym (pre-exposure prophylaxis)', 'Behavioral: Initial Web Survey', 'Behavioral: Interactive Voice Response (IVR) assessment with personalized information', 'Behavioral: Personalized information based on web-based survey responses & standardized information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Information', 'description': 'Participants randomized to this condition will complete a web-based questionnaire and then receive educational material regarding their alcohol use and sexual health behavior. They will complete daily phone-based IVR monitoring for assessment purposes.', 'interventionNames': ['Drug: PrEP acronym (pre-exposure prophylaxis)', 'Behavioral: Initial Web Survey', 'Behavioral: Interactive Voice Response (IVR) monitoring', 'Behavioral: Educational material on alcohol and sexual health behavior']}], 'interventions': [{'name': 'PrEP acronym (pre-exposure prophylaxis)', 'type': 'DRUG', 'otherNames': ['emtricitabine/tenofovir disoproxil fumarate'], 'description': 'A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.', 'armGroupLabels': ['Educational Information', 'Personalized Information']}, {'name': 'Initial Web Survey', 'type': 'BEHAVIORAL', 'description': 'Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors', 'armGroupLabels': ['Educational Information', 'Personalized Information']}, {'name': 'Interactive Voice Response (IVR) monitoring', 'type': 'BEHAVIORAL', 'description': 'Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking', 'armGroupLabels': ['Educational Information']}, {'name': 'Educational material on alcohol and sexual health behavior', 'type': 'BEHAVIORAL', 'description': 'Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.', 'armGroupLabels': ['Educational Information']}, {'name': 'Interactive Voice Response (IVR) assessment with personalized information', 'type': 'BEHAVIORAL', 'description': 'Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking with personalized and information based on daily IVR responses', 'armGroupLabels': ['Personalized Information']}, {'name': 'Personalized information based on web-based survey responses & standardized information', 'type': 'BEHAVIORAL', 'description': 'Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.', 'armGroupLabels': ['Personalized Information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert L. Cook, PhD', 'role': 'CONTACT', 'email': 'cookrl@ufl.edu', 'phone': '352-273-5869'}, {'name': 'Robert L. Cook, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'centralContacts': [{'name': 'Robert L. Cook, PhD', 'role': 'CONTACT', 'email': 'cookrl@ufl.edu', 'phone': '(352) 273-5869'}], 'overallOfficials': [{'name': 'Robert L. Cook, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}