PrEP + Alcohol & Sexual Health Education for Substance Use Disorders

This trial examines how alcohol and sexual health education can prevent HIV in young adult men who drink heavily and engage in unprotected sex with other men. Participants will receive either general or personalized education about alcohol use and sexual health. They will take PrEP, a medication that helps prevent HIV, and report their experiences daily over the phone for 30 days. The trial seeks young men who consume five or more drinks in one day and have had unprotected sex with another man in the past month. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective PrEP benefits more patients, offering participants a chance to contribute to broader public health knowledge.

The trial requires that you do not take medications that interfere with PrEP, such as diuretics, certain pain relievers, or other antiretroviral drugs. If you are on these medications, you may need to stop them to participate.

Research has shown that PrEP (pre-exposure prophylaxis) is generally safe for use. One study found that Truvada, a common type of PrEP, was well-tolerated when taken daily to prevent HIV. Another study reported no major safety issues over 96 weeks, even across different age, race, and gender groups. However, some individuals may experience side effects like nausea or headaches. It's important to note that alcohol or drug use can affect PrEP's effectiveness by leading to missed doses. Overall, PrEP maintains a strong safety record in preventing HIV.¹²³⁴⁵

Researchers are excited about this trial because it explores a unique combination of PrEP (pre-exposure prophylaxis) with tailored alcohol and sexual health education for individuals with substance use disorders. Unlike traditional methods that focus solely on medication, this approach integrates educational components that are personalized based on individual behavior patterns. This could lead to more effective prevention strategies by addressing the holistic needs of participants, potentially improving adherence and outcomes in a population that is often challenging to reach with standard interventions. The trial aims to assess whether these personalized educational interventions can enhance the effectiveness of PrEP, offering a more comprehensive method to reduce HIV transmission risk.

Research has shown that PrEP (pre-exposure prophylaxis) effectively prevents HIV. One study found that DESCOVY, a type of PrEP, performed as well as other treatments in preventing HIV over 96 weeks. Another study demonstrated that taking Truvada PrEP daily is safe and well-accepted, making it a reliable part of HIV prevention. These findings suggest that PrEP is a strong option for reducing the risk of HIV, especially when taken consistently. Participants in this trial will receive educational or personalized information on alcohol and sexual health behavior, alongside PrEP, to assess its effectiveness in this context.¹²⁵⁶⁷