PrEP + Alcohol & Sexual Health Education for Substance Use Disorders
Palo Alto (17 mi)Age: 18 - 65
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Florida
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
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.
Is the drug PrEP a promising treatment?Yes, PrEP is a promising drug for preventing HIV. It has been shown to be effective in reducing the risk of HIV infection in people who are at high risk, such as men who have sex with men and others. It is widely used in the USA and is becoming an important part of global efforts to prevent HIV.123411
What safety data exists for PrEP and related educational interventions?PrEP, particularly using Truvada (tenofovir disoproxil fumarate/emtricitabine), has been shown to be effective in reducing HIV transmission among high-risk groups. Clinical trials and real-world data indicate that PrEP has a good safety profile, with common side effects being mild gastrointestinal issues like nausea, vomiting, and diarrhea. Monitoring liver enzymes, renal function, and bone mineral density is recommended to prevent long-term adverse effects. While PrEP is generally safe, there is a concern about increased sexually transmitted infections (STIs) due to potential risk compensation behaviors. Therefore, ongoing adherence monitoring and safety surveillance are crucial to maintain the benefits observed in clinical trials.145611
What data supports the idea that PrEP + Alcohol & Sexual Health Education for Substance Use Disorders is an effective treatment?The available research shows that PrEP is effective in reducing the risk of HIV infection among high-risk individuals, including those with substance use disorders. However, the uptake of PrEP among women with substance use disorders is low due to lack of awareness and perceived risk. Studies suggest that integrating PrEP with alcohol and sexual health education could help address these barriers by making PrEP more meaningful and accessible. Women in substance use treatment programs expressed willingness to use PrEP, especially when they perceived themselves at high risk. The combination of PrEP with education could improve motivation and adherence, making it a potentially effective treatment.578910
Do I have to stop taking my current medications for the trial?The trial requires you to stop taking medications that interfere with PrEP, such as diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs, or other drugs that may interfere with tenofovir excretion.
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
I have had unprotected sex with a man in the last 30 days.
Exclusion Criteria
I am not taking drugs that affect PrEP, like water pills or certain pain relievers.
I am currently using injectable PrEP.
I have an active hepatitis B infection.
Treatment Details
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.
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, United States, European Union for the following indications:
🇺🇸 Approved in United States as Truvada for:
- HIV prevention
🇪🇺 Approved in European Union as Truvada for:
- HIV prevention
🇺🇸 Approved in United States as Descovy for:
- HIV prevention
🇪🇺 Approved in European Union as Descovy for:
- HIV prevention
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who is running the clinical trial?
University of FloridaLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Are we prepped for preexposure prophylaxis (PrEP)? Provider opinions on the real-world use of PrEP in the United States and Canada. [2022]Preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (Truvada) has demonstrated efficacy in placebo-controlled clinical trials involving men who have sex with men, high-risk heterosexuals, serodiscordant couples, and intravenous drug users. To assist in the real-world provision of PrEP, the Centers for Disease Control and Prevention (CDC) has released guidance documents for PrEP use.
Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]The HIV antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (Truvada) was recently approved as preexposure prophylaxis (PrEP) therapy for adults at high risk for sexually acquired HIV infection. This article reviews the data supporting the efficacy of PrEP, and provides other relevant data regarding the implementation of PrEP.
Two years of Truvada for pre-exposure prophylaxis utilization in the US. [2018]Truvada® (TVD) was approved in July 2012 by the US FDA for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in high-risk adults. This study explores the characteristics of US PrEP users and their prescribers over the past two years.
The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. [2023]This article describes the use of tenofovir/emtricitabine (Truvada) as prevention for exposure to HIV [preexposure prophylaxis (PrEP)] infection in the USA. The use of PrEP and the challenges of implementation are very instructive as other countries adopt this intervention and it becomes a fundamental part of worldwide efforts for HIV prevention and much can be learned from the first 3 years in the USA.
Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits observed in clinical trials are maintained in real-world use.
Sexually Transmitted Infections on the Rise in PrEP Users. [2020]Pre-exposure prophylaxis (PrEP) with oral Truvada (tenofovir plus emtricitabine) is effective at preventing HIV infection in high-risk homosexual men. In the United States, PrEP was approved in 2012 and is reimbursed by Medicaid and the majority of private insurers. The situation is diverse and not uniform in the European Union, being PrEP more widely used in France than in the rest of countries. Concerns have been raised that PrEP use may be accompanied by the phenomena of risk compensation or behavioral disinhibition, whereby PrEP users' perception of decreased risk of HIV acquisition may lead them to engage in overall riskier sexual practices and increase their chances of acquiring sexually transmitted infections (STIs) (Blumenthal, et al. Virtual Mentor. 2014;16:909-15). Modifiable factors that may influence the acquisition of STI include condom use, number of partners, partner characteristics, and healthcare-seeking behaviors. In addition, MSM may alter HIV risk mitigation practices while on PrEP by decreasing seroadaptive practices such as serosorting that is seeking a partner of similar perceived serostatus (Khosopour, et al. AIDS Behav. 2017;21:2935-44). High rates of STI have been reported among PrEP users, as well as high rates of condomless sex, and increasing rates of STI over time (Liu, et al. JAMA Intern Med. 2016;176:75-84; Kojima, et al. AIDS, 2016;30:2251-2). In a new study conducted in Montreal, Canada, increases in the rates of STI in PrEP users were demonstrated measuring incidence rates of STI before and following the initiation of PrEP in the same cohort. The authors measured the incidence of gonorrhea, chlamydia, and/or syphilis in 109 HIV-seronegative homosexual men 12 months before and 12 months after beginning Truvada for HIV prevention (Nguyen, et al. AIDS. 2018;32:523-30). New episodes of gonorrhea, chlamydia, and/or syphilis rose in the cohort after providing Truvada, as shown in Figure 1. Moreover, the incidence of three or more STI increased from 3.7 to 9.2 cases per 100 personyears in this cohort. The Canadian study highlighted that the rate of STI with PrEP was also higher than in a group of 86 homosexual men that had undergone PEP in Montreal during 2010-2015. Other findings of the study we the high rate of STI with anorectal location, symptomless STI (e.g., chlamydia) and the frequency of sex partners contacted by internet. The increased rates of STI in PrEP users suggest a need to reinforce counseling and STI diagnosis and treatment efforts. Although PrEP may provide a public health benefit beyond the immediate prevention of HIV infection as result of bringing into care high-risk homosexual men who might not otherwise be seeking care for STI, doctors in charge must take this opportunity for informing adequately on STI and the risks inherent to multiple and occasional sexual contacts.
Women's Decision-Making about PrEP for HIV Prevention in Drug Treatment Contexts. [2022]Despite pre-exposure prophylaxis's (PrEP) efficacy for HIV prevention, uptake has been low among women with substance use disorders (SUDs) and attributed to women's lack of awareness. In semistructured interviews with 20 women with SUD and 15 key stakeholders at drug treatment centers, we assessed PrEP awareness and health-related decision-making. Women often misestimated their own HIV risk and were not aware of PrEP as a personally relevant option. Although women possessed key decision-making skills, behavior was ultimately shaped by their level of motivation to engage in HIV prevention. Motivation was challenged by competing priorities, minimization of perceived risk, and anticipated stigma. Providers were familiar but lacked experience with PrEP and were concerned about women's abilities to action plan in early recovery. HIV prevention for women with SUD should focus on immediately intervenable targets such as making PrEP meaningful to women and pursuing long-term systemic changes in policy and culture. Efforts can be facilitated by partnering with drug treatment centers to reach women and implement PrEP interventions.
Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. [2022]Women with substance use disorders (SUDs) are a key population for HIV prevention with pre-exposure prophylaxis (PrEP), though uptake is limited by awareness of PrEP, misestimation of personal HIV risk, and minimally integrated HIV prevention and addiction treatment services. Patient-centered decision aids (DA) could address these barriers to PrEP, but no extant DA for PrEP has been published, including for women with SUDs.
A Qualitative Study of Barriers and Facilitators of PrEP Uptake Among Women in Substance Use Treatment and Syringe Service Programs. [2023]PrEP is an HIV prevention option that could benefit substance-involved women, a high-risk population with low PrEP uptake. Little is known about their interest in PrEP. This qualitative study used in-depth interviews to examine PrEP willingness, barriers, and facilitators among 16 women in outpatient psychosocial substance use treatment, methadone, and/or harm reduction/syringe programs in NYC. All expressed willingness to use PrEP, but only during periods of perceived risk. Women perceived themselves to be at high risk for HIV when engaging in active substance use and/or transactional sex. They perceived themselves to be at low risk and therefore unmotivated to take PrEP when abstinent from these activities. Paradoxically, a major barrier to using PrEP was anticipated interference from substance use and transactional sex, the very same activities that create a perception of risk. Facilitators of PrEP use included perceptions of it as effortless (as opposed to barrier methods during sex) and effective, safe, and accessible. Other barriers included fear of stigma and doubts about adhering daily. Recommendations for best PrEP implementation practices for substance-involved women included tailored and venue-specific PrEP information and messaging, PrEP discussion with trusted medical providers, and on-site PrEP prescription in substance use treatment and harm reduction programs.
Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder. [2023]We seek to evaluate risk factors for eligibility for preexposure prophylaxis (PrEP) among pregnant people with opioid use disorder (OUD).
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]Pre-exposure prophylaxis (PrEP) against HIV infection is a new approach that involves the prophylactic use of the anti-HIV drug Truvada (tenofovir disoproxil fumarate [TDF] and emtricitabine [FTC]) by people not infected with HIV.