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ANCHORS Alcohol & Sexual Health Study: UH3 Project

StatusRecruiting
PhasePhase 4
Started2021-01-12
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 10, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-09
Study Status v9
Primary completion date2025-06-30→2025-12-31
Completion date2025-12-31→2026-06-30
2024-12-09
Study Status v8
Primary completion date2024-08-31→2025-06-30
Completion date2024-08-31→2025-12-31
2023-11-28
Study Status v7
Primary completion date2023-08-31→2024-08-31
Completion date2023-08-31→2024-08-31
2023-04-17
Study Status, Eligibility, Contacts/Locations v6
Primary completion date2022-08-31→2023-08-31
Completion date2022-08-31→2023-08-31
Eligibility criteria+140 characters
Inclusion Criteria: Ability to read and write English FrequentConsumption alcoholof consumption5 or more drinks per drinks in a day at least once in the past 30-days Recent sexualSexual intercourse with another man without condom use at least once in the past 30 days HIV seronegative at medical screening Report currently taking PrEP awillingness maximumto oftake four times per week in the last monthPrEP Exclusion Criteria: History of clinically significant withd [...] ogic, or pancreatic function according to laboratory testing Participant reports currently taking injectable PrEP
Study sitescontacts updated at 1 of 1 site
2022-01-27
Study Status, Eligibility v5
Eligibility criteria+833 characters
Inclusion Criteria: abilityAbility to read and write English frequentFrequent alcohol consumption recentRecent sexual intercourse with another man HIV seronegative at medical screening Report taking PrEP a maximum of four times per week in the last month Exclusion Criteria: notHistory inof clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal urine; testb) negativea Clinical Institute Withdrawal Assessment scale score > 8; c) a report of drinking to avoid withdrawal symptoms [...] [...]
Show 4 earlier versions
2021-03-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-01-12
Study sitesdetails revised at 1 of 1 site
2020-12-07
Study Status v3
Start date2020-11→2021-01
2020-09-04
Study Identification, Study Status v2
Start date2020-08→2020-11
2020-06-23
Study Status v1
Start date2020-05→2020-08
2020-03-31
Original filing
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.
Trial Details
NCT Number NCT04331704
Lead Sponsor University of Florida
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use, Unspecified, Substance Use, Sex Behavior
Enrollment 88 participants
Start Date 2021-01-12
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-10