PrEP + Alcohol & Sexual Health Education for Substance Use Disorders
Trial Summary
Do I have to stop taking my current medications for this trial?
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.
What data supports the effectiveness of this treatment for substance use disorders?
The treatment includes pre-exposure prophylaxis (PrEP), which has been shown to effectively reduce the risk of HIV infection among high-risk individuals, including those with substance use disorders. Additionally, personalized education and decision aids can help increase awareness and motivation to use PrEP, addressing barriers such as misestimation of HIV risk and lack of awareness.12345
Is the combination of PrEP and alcohol/sexual health education safe for humans?
PrEP (pre-exposure prophylaxis) is generally considered safe for preventing HIV, and it has been used successfully in various populations, including those with substance use disorders. While specific safety data for the combination of PrEP with alcohol and sexual health education is not detailed, PrEP itself has a well-established safety profile.678910
How is the drug PrEP unique for substance use disorders?
PrEP (Pre-exposure prophylaxis) is unique because it uses the anti-HIV drug Truvada, which combines two medications, tenofovir and emtricitabine, to prevent HIV infection in people who are not yet infected. This approach is novel for substance use disorders as it focuses on preventing HIV in high-risk individuals, which is different from traditional treatments that typically address the substance use itself.1112131415
What is the purpose of this trial?
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.
Research Team
Robert L. Cook, PhD
Principal Investigator
University of Florida
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants complete an initial survey and receive alcohol and sexual health education. They take PrEP and complete daily IVR assessments for 30 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 1 month and 6 months.
Treatment Details
Interventions
- Educational material on alcohol and sexual health behavior
- Initial Web Survey
- Interactive Voice Response (IVR) assessment with personalized information
- Interactive Voice Response (IVR) monitoring
- Personalized information based on web-based survey responses & standardized information
- PrEP
PrEP is already approved in United States, European Union for the following indications:
- HIV prevention
- HIV prevention
- HIV prevention
- HIV prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator