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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

Must not have

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

Participant reports currently taking injectable PrEP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 and 6-month follow-up

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

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.

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.

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

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I have had unprotected sex with a man in the last 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking drugs that affect PrEP, like water pills or certain pain relievers.

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I am currently using injectable PrEP.

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I have an active hepatitis B infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 and 6-month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in peak drinking quantity

Change in quantity of drinks per week

PrEP levels in blood at end of intervention period

+3 more

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

0 / 4Eligibility criteria met