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Antiviral

PrEP + Alcohol & Sexual Health Education for Substance Use Disorders

Phase 4
Recruiting
Led By Robert L. Cook, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexual intercourse with another man without condom use at least once in the past 30 days
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 and 6-month follow-up
Awards & highlights

Study Summary

This trial will study the effects of two different types of alcohol and sexual health education on 80 young adult men, in order to encourage the prevention of alcohol-related problems, HIV, and other STIs. The participants will take active PrEP medication and complete daily 5-minute assessments, via telephone, for 30 days. Follow-up will occur after 30-days and 6-months.

Who is the study for?
The trial is for young adult men who can read/write English, have had high alcohol consumption and unprotected sex with another man in the past month. They must be HIV negative, not currently on injectable PrEP but willing to take oral PrEP. Excluded are those with severe alcohol withdrawal history, injection drug use, serious substance disorders (except alcohol/nicotine), psychiatric symptoms, or taking medications that affect PrEP.Check my eligibility
What is being tested?
This study tests the effectiveness of daily pre-exposure prophylaxis (PrEP) for HIV prevention combined with two types of educational interventions on alcohol and sexual health. Participants will also engage in a daily interactive voice response system to monitor their behavior over a period of 30 days followed by check-ins after one month and six months.See study design
What are the potential side effects?
Since all participants receive active PrEP medication without placebo control, potential side effects include digestive issues like nausea or diarrhea, headaches, fatigue and rare cases might involve liver problems or bone thinning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had unprotected sex with a man in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 and 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in peak drinking quantity
Change in quantity of drinks per week
PrEP levels in blood at end of intervention period
+3 more
Secondary outcome measures
Change in perceived risk of HIV as a reason for adherence to PrEP
Change in sexual risk behavior as a reason for adherence to PrEP
Increased motivation for behavior change as a reason for adherence to PrEP
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized InformationExperimental Treatment4 Interventions
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.
Group II: Educational InformationActive Control4 Interventions
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.

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,309 Total Patients Enrolled
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,590 Total Patients Enrolled
Robert L. Cook, PhDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ANCHORS Alcohol & Sexual Health Study: UH3 Project
2021. "ANCHORS Alcohol & Sexual Health Study: UH3 Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04331704.
All > Substance Abuse
~8 spots leftby Aug 2024
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