Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
88 participants
INTERVENTIONAL
2021-01-12
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Personalized Information
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.
PrEP acronym (pre-exposure prophylaxis)
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Interactive Voice Response (IVR) assessment with personalized information
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
Personalized information based on web-based survey responses & standardized information
Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Educational Information
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.
PrEP acronym (pre-exposure prophylaxis)
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Interactive Voice Response (IVR) monitoring
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
Educational material on alcohol and sexual health behavior
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
Interventions
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PrEP acronym (pre-exposure prophylaxis)
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Interactive Voice Response (IVR) monitoring
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
Educational material on alcohol and sexual health behavior
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
Interactive Voice Response (IVR) assessment with personalized information
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
Personalized information based on web-based survey responses & standardized information
Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
* Sexual intercourse with another man without condom use at least once in the past 30 days
* HIV seronegative at medical screening
* Report currently taking PrEP willingness to take PrEP
Exclusion Criteria
* Self report injection drug use
* DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
* Serious psychiatric symptoms
* 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
* Active hepatitis B infection
* The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing
* Participant reports currently taking injectable PrEP
18 Years
30 Years
MALE
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Robert L. Cook, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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