PrEP clinical trials at University of California Health

14 in progress, 9 open to eligible people

Showing trials for

  • ASK-PrEP (Assistance Services Knowledge-PrEP)

    open to eligible males ages 18 years and up

    ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.

    at UCLA

  • EASE: The Materna Prep Pivotal Study

    open to eligible females ages 18 years and up

    This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.

    at UCLA

  • eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum

    open to eligible males ages 18 years and up

    The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for racially/ethnically diverse transgender women (TW) and gay, bisexual, and other men who have sex with men (GBMSM) disproportionately impacted by the HIV epidemic. To reach this goal, the investigators will compare study outcomes among persons randomized to use a mobile app (eSTEP) intervention tailored to the unique needs of TW and GBMSM with interactive components delivered before in-person HIV testing and PrEP initiation visit and interactive components delivered after PrEP is initiated. The eSTEP group will be compared to usual HIV testing and PrEP care.

    at UCSD

  • Onboarding Positives and PrEP Users to Engage Negatives (OPPEN): Peer-driven Education to Link YMSM of Color to PrEP

    open to eligible males ages 18-34

    Onboarding Positives and PrEP users to Engage Negatives (OPPEN) is an intervention to train young men who have sex with men (YMSM) of color living with HIV or using pre-exposure prophylaxis (PrEP) to promote PrEP use among HIV-negative YMSM of color in their social networks. This pilot randomized controlled trial will evaluate OPPEN's acceptability, feasibility, and preliminary effect on PrEP care engagement among YMSM of color.

    at UCSD

  • Optimizing PrEP Uptake and Adherence Among Male Sex Workers

    open to eligible males ages 18 years and up

    "PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

    at UCLA

  • PrEP Affect Regulation Treatment Innovation

    open to eligible males ages 18 years and up

    This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.

    at UCSF

  • PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men

    open to eligible males ages 18-30

    Despite advances in HIV prevention, the HIV incidence among young men who have sex with men (YMSM) is increasing, threatening to derail achievement of the United States End the HIV Epidemic goals. Although, pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method, adherence was sufficiently low to comprise efficacy among a high proportion of YMSM in multiple clinical trials and demonstration projects. In this study, the investigators will leverage a novel urine point-of-care drug-level test for PrEP adherence, to both enhance and target motivational-interviewing-based adherence counseling among YMSM, with the goal of preventing HIV infections among this critically at-risk group.

    at UCSF

  • Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

    open to eligible people ages 18 years and up

    The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US). The primary objectives of this study are to characterize the pharmacokinetics (PK) of LEN and to evaluate the safety of LEN and F/TDF for PrEP in US PWID.

    at UCSD

  • Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

    open to eligible females ages 18 years and up

    The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.

    at UCSD

  • ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR

    Sorry, not currently recruiting here

    This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.

    at UCLA

  • Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)

    Sorry, in progress, not accepting new patients

    This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their PrEP medication. The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

    at UCSD

  • Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.

    at UCSD

  • Naltrexone for Overdose Prevention

    Sorry, not yet accepting patients

    The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are: What are the challenges for implementing naltrexone as an overdose prevention strategy? Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants? How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids? Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other. Participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.

    at UCSF

  • Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    Sorry, in progress, not accepting new patients

    The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.

    at UCLA UCSD

Our lead scientists for PrEP research studies include .

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