PrEP + Alcohol & Sexual Health Education for Substance Use Disorders
Recruiting in 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
Must be taking: PrEP
Must not be taking: Diuretics, Nephrotoxic drugs, NSAIDs, Antiretrovirals
Disqualifiers: Injection drug use, Hepatitis B, others
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.
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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
+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.
+5 more
Trial 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
Participant Groups
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
Loading ...
Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
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.
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.
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).
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.
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.
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]Substance Use Disorder (SUD) treatment is a promising setting to provide sexual health education to women. This study examined barriers and possible solutions to effectively providing sexual health education and services during SUD treatment.
Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV. [2021]Infrequent use of and poor retention on evidence-based medications for alcohol use disorder (MAUD) represent a treatment gap, particularly among people living with HIV (PLWH). We examined predictors of MAUD initiation and retention across HIV status.
HIV prevention for people who use substances: evidence-based strategies. [2021]Evidence-based strategies to guide HIV prevention for people who use substances can be grouped into approaches that lower infectiousness among substance users living with HIV and those that prevent HIV acquisition among those who are uninfected. Dramatic successes in HIV prevention involving access to antiretroviral therapy (ART), opioid substitution therapies, and needle and syringe exchange programs have reduced both prevalence and incidence in the United States for people who use injection drugs, and modeling studies suggest that scale-up of these approaches will have a parallel impact worldwide. Medical HIV-prevention strategies that reduce infectiousness ("treatment as prevention" or early ART initiation) and that block HIV acquisition (pre-exposure prophylaxis, post-exposure prophylaxis) can constitute key elements of novel combination HIV-prevention approaches to the goals of reducing infectiousness and reducing acquisition of HIV among people who use substances. For individuals who use substances but do not inject, drug dependence treatments as HIV prevention have a meager evidence-base, with most consistent findings being reduction of sexual transmission behaviors that correspond with reductions in substance use, though not with prevention of HIV transmission. This approach may have value, however, when working with groups of substance users who face high rates of HIV prevalence and incidence. Some evidence exists to support HIV prevention interventions that target reduction of sexual risk behaviors in the setting of active stimulant use.
Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review. [2023]Because alcohol use disorders (AUDs) in patients living with HIV/AIDS are associated with a reduction in therapeutic outcomes and increases the risk of morbidity/mortality, finding an appropriate pharmacotherapy treatment for this disorder is necessary.
Testing and Case Rates of Gonorrhea, Chlamydia, Syphilis, and HIV among People with Substance Use Disorders in the Veterans Health Administration. [2023]Little is known about national patterns of sexually transmitted infection (STI) testing and infections among people with substance use disorders (SUDs).
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.
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.
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.