A Phase 4 interventional study of PrEP acronym (pre-exposure prophylaxis) and Initial Web Survey in Alcohol Use, Unspecified, Substance Use and Sex Behavior, sponsored by University of Florida. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by University of Florida · Phase 4, Interventional, and Prevention
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 88 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
Also known as: emtricitabine/tenofovir disoproxil fumarate
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
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 and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Change in quantity of drinks per week
Change in self-reported number of alcoholic drinks per week
Time frame: Baseline up to 1 and 6-month follow-up
Change in peak drinking quantity
Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days
Time frame: Baseline up to 1 and 6-month follow-up
PrEP levels in blood at end of intervention period
Determine whether or not participants have therapeutic levels of PrEP in their blood samples
Time frame: 1-month follow-up
PrEP levels in blood at the end of the follow-up period
Determine whether or not participants have therapeutic levels of PrEP in their blood samples
Time frame: 6-month follow-up
PrEP prescription fill with supporting documentation in the intervention period
Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation
Time frame: during the 1-month intervention period
PrEP prescription fills with supporting documentation during the follow-up period
Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation
Time frame: the 6-month follow-up period
Reduced alcohol use as a reason for adherence to PrEP
Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP
Time frame: Baseline up to 1 and 6-month follow-up
Change in perceived risk of HIV as a reason for adherence to PrEP
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
Time frame: Baseline up to 1 and 6-month follow-up
Change in sexual risk behavior as a reason for adherence to PrEP
Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP
Time frame: Baseline up to 1 and 6-month follow-up
Increased motivation for behavior change as a reason for adherence to PrEP
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
Time frame: Baseline up to 1 and 6-month follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Dec 2025, 59 months after the start.
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