88 Participants Needed

PrEP + Alcohol & Sexual Health Education for Substance Use Disorders

RL
RL
Overseen ByRobert L. Cook, PhD
Age: 18 - 65
Sex: Male
Trial Phase: Phase 4
Sponsor: University of Florida
Must be taking: PrEP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

RL

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

Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
Ability to read and write English
HIV seronegative at medical screening
See 2 more

Exclusion Criteria

DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine
History of clinically significant withdrawal from alcohol
I am not taking drugs that affect PrEP, like water pills or certain pain relievers.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete an initial survey and receive alcohol and sexual health education. They take PrEP and complete daily IVR assessments for 30 days.

4 weeks
Daily phone-based IVR assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 1 month and 6 months.

6 months
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
Trial Overview 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.
Participant Groups
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.

PrEP is already approved in United States, European Union for the following indications:

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Approved in United States as Truvada for:
  • HIV prevention
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Approved in European Union as Truvada for:
  • HIV prevention
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Approved in United States as Descovy for:
  • HIV prevention
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Approved in European Union as Descovy for:
  • HIV prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Findings from Research

The patient-centered decision aid (DA) for PrEP significantly increased interest in PrEP among women in addiction treatment, with interest rising from 25% to 89% for those who chose to use the DA.
Women using the DA were more likely to see a healthcare provider for PrEP compared to those receiving enhanced standard of care, indicating that the DA effectively engaged participants in the HIV prevention process.
Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders.Meyer, J., Price, C., Tracey, D., et al.[2022]
Women with substance use disorders (SUDs) often lack awareness of their HIV risk and the availability of pre-exposure prophylaxis (PrEP), which contributes to low uptake of this effective prevention method.
Motivation to engage in HIV prevention among these women is influenced by competing life priorities, a minimization of perceived risk, and anticipated stigma, highlighting the need for targeted interventions that make PrEP more relevant and accessible.
Women's Decision-Making about PrEP for HIV Prevention in Drug Treatment Contexts.Qin, Y., Price, C., Rutledge, R., et al.[2022]
In a study of 132 pregnant individuals with opioid use disorder (OUD), 76.5% were found eligible for preexposure prophylaxis (PrEP) based on modified ACOG criteria, highlighting a significant need for PrEP among this population.
Comorbid psychiatric illness was identified as a significant risk factor for PrEP eligibility, suggesting that mental health support may be crucial in managing pregnant individuals with OUD and assessing their risk for HIV.
Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder.Young, AMP., Reddy, P., Gonzalez, AM., et al.[2023]

References

Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. [2022]
Women's Decision-Making about PrEP for HIV Prevention in Drug Treatment Contexts. [2022]
Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder. [2023]
A Qualitative Study of Barriers and Facilitators of PrEP Uptake Among Women in Substance Use Treatment and Syringe Service Programs. [2023]
Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]
Sex and Female Empowerment (SAFE): Learning from health care providers, men and women to design a sexual health intervention for women with substance use disorders. [2023]
Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV. [2021]
8.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
HIV prevention for people who use substances: evidence-based strategies. [2021]
Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review. [2023]
Testing and Case Rates of Gonorrhea, Chlamydia, Syphilis, and HIV among People with Substance Use Disorders in the Veterans Health Administration. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Are we prepped for preexposure prophylaxis (PrEP)? Provider opinions on the real-world use of PrEP in the United States and Canada. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]
Two years of Truvada for pre-exposure prophylaxis utilization in the US. [2018]
Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. [2023]
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