PrEP Behavioral Intervention for HIV/AIDS Prevention (PrEP Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brown University
No Placebo Group
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications. It focuses on people who have never taken PrEP before, but it doesn't mention other medications.
Is the drug PrEP for Health a promising treatment for HIV/AIDS prevention?Yes, PrEP for Health, which includes drugs like Truvada, is a promising treatment for preventing HIV. It is highly effective for people at high risk of getting HIV, helping to significantly reduce the chances of infection when taken consistently.12458
What safety data is available for PrEP treatments like Truvada and Descovy?The DISCOVER trial found that tenofovir alafenamide (Descovy) has improved renal and bone safety compared to tenofovir disoproxil fumarate (Truvada) for HIV prevention. Truvada is highly effective against HIV, with rare cases of infection reported under high adherence. Safety during pregnancy is uncertain, with ongoing studies comparing outcomes in women exposed to PrEP.14567
What data supports the idea that PrEP Behavioral Intervention for HIV/AIDS Prevention is an effective drug?The available research shows that PrEP, specifically using the drugs emtricitabine and tenofovir disoproxil fumarate (Truvada), is highly effective in preventing HIV infection in high-risk adults. One study highlights that only two cases of infection with a resistant virus have been reported when the drug was used correctly over a long period. Another study compared two forms of the drug and found both to be effective, with one version offering better safety for kidneys and bones. Overall, these studies support the effectiveness of PrEP in reducing the risk of HIV infection.13456
Eligibility Criteria
This trial is for people who inject drugs, are at risk for HIV, have never taken PrEP (a medication to prevent HIV), and engage in behaviors like sharing needles or having unprotected sex. Participants must not be on PrEP currently, understand English or Spanish, and plan to stay in Massachusetts for at least a year.Inclusion Criteria
I have never taken PrEP.
I can understand and speak English or Spanish.
Participant Groups
The study tests 'PrEP for Health,' which includes education about HIV/PrEP, motivational talks, planning help, and patient navigation versus just getting information and referrals. The goal is to see if the program helps participants start and stick with PrEP over time by checking drug levels in their hair.
2Treatment groups
Experimental Treatment
Active Control
Group I: PrEP for healthExperimental Treatment5 Interventions
Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.
Group II: Standard of careActive Control2 Interventions
Participants in the standard of care arm will receive PrEP information and referrals.
PrEP for Health is already approved in United States, United States, United States, European Union, European Union for the following indications:
🇺🇸 Approved in United States as Truvada for:
- Pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents
🇺🇸 Approved in United States as Descovy for:
- Pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents, excluding cisgender women
🇺🇸 Approved in United States as Apretude for:
- Pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents
🇪🇺 Approved in European Union as Truvada for:
- Pre-exposure prophylaxis (PrEP) for HIV prevention in adults
🇪🇺 Approved in European Union as Apretude for:
- Pre-exposure prophylaxis (PrEP) for HIV prevention in adults
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Greater Lawrence Family Health CenterLawrence, MA
AIDS ActionCambridge, MA
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Who is running the clinical trial?
Brown UniversityLead Sponsor
University of California, San DiegoCollaborator
Greater Lawrence Family Health CenterCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
AIDS Action Committee of MassachusettsCollaborator
Beth Israel Deaconess Medical CenterCollaborator
The Fenway InstituteCollaborator
References
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.
Role of oral pre-exposure prophylaxis (PrEP) in current and future HIV prevention strategies. [2021]Treatment as prevention is expected to have a major role in reducing HIV incidence, but other prevention interventions will also be required to bring the epidemic under control, particularly among key populations. One or more forms of pre-exposure prophylaxis (PrEP) will likely play a critical role. Oral PrEP with emtricitabine-tenofovir (Truvada®) is currently available in the US and some other countries, but uptake has been slow. We review the concerns that have contributed to this slow uptake and discuss current and future research in this critical area of HIV prevention research.
Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis. [2022]Preexposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate (FTC/TDF) or TDF alone reduces the risk of human immunodeficiency virus (HIV) acquisition. Understanding the risk of antiretroviral resistance selected by PrEP during breakthrough infections is important because of the risk of treatment failure during subsequent antiretroviral use.
Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report. [2022]Pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate is highly effective against acquisition of HIV infection, and only two cases of infection with a multidrug-resistant virus have been reported under adequate long-term adherence, as evidenced by tenofovir diphosphate concentrations in dried blood spots. We report a case of wild-type HIV-1 infection despite consistent use of emtricitabine and tenofovir disoproxil fumarate.
Acquisition of tenofovir-susceptible, emtricitabine-resistant HIV despite high adherence to daily pre-exposure prophylaxis: a case report. [2023]Pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate is highly protective against HIV infection. We report a case of tenofovir-susceptible, emtricitabine-resistant HIV acquisition despite high adherence to daily PrEP.
Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. [2022]Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention.
Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. [2023]The safety of tenofovir disoproxil fumarate and emtricitabine as pre-exposure prophylaxis (PrEP) in pregnant women not living with HIV is uncertain. We aimed to compare pregnancy and neonatal outcomes in women exposed and not exposed to PrEP during pregnancy.
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.