UCLA Vine Street Clinic

The UCLA Vine Street Clinic (UVSC) was established in 2005 in order to study the diffusion of HIV among methamphetamine user networks. Since that time, it has served as a site for clinical trials, behavioral research, and direct services focusing on the treatment of addiction, HIV prevention, and the intersection of the two. It is unique in its location, bringing the best in academia from UCLA into a transitional neighborhood of predominately working poor, an area designated as a medically underserved. The facility includes exam and counseling rooms for patient care and a lab for collection and storage of biological samples. Current projects on-going at the clinic are detailed below.

For more information or to schedule an appointment, call us at (323) 461-3106 or email us at uclavsc@mednet.ucla.edu.

Our Current Programs Include:

RELEVANCE: Determining whether a patient is both feeling better and improving physiologically when treating people living with HIV (PLWH) for methamphetamine use disorder (MUD) requires identification of a clinically significant measure separate from abstinence. This study aims to address this challenge by testing a gene expression pattern identified by the field of social genomics, which may provide insight into both psychosocial health and biological processes that impact chronic disease risk in PLWH receiving MUD treatment.

DESCRIPTION: The purpose of this study is examine methamphetamine treatment and its impact on immune function and mental health. It aims to investigate whether a neurally regulated “stress” gene expression pattern can serve as a clinically meaningful, non-abstinence-based endpoint for contingency management for methamphetamine (METH) use disorder (MUD) in MSM living with HIV.

STATUS: This study is currently active and enrolling participants at the UCLA Vine Street Clinic. Click here for more information.

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RELEVANCE: PrEP agents are needed that do not depend on daily or near-daily pill-taking. The development of alternative agents for PrEP, and/or more adherence-friendly schedules for currently available agents, could increase prevention choices and increase acceptability. Long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen.

DESCRIPTION: Once randomized to one of two arms, participants will move through the steps below and followed for up to 4 and a half years:

Step 1:
Arm A – Daily oral CAB (30 mg tablets) and oral TDF/FTC placebo for five weeks
Arm B – Daily oral TDF/FTC (300 mg/200 mg fixed-dose combination tablets) and oral CAB placebo for five weeks
A participant that becomes HIV-infected during Step 1 of the study will permanently discontinue study product and will be terminated from the study, and referred for HIV-related care.
Step 2:
Arm A – CAB LA (600 mg as a single intramuscular [IM] injection at two time points 4 weeks apart and every 8 weeks thereafter) and daily oral TDF/FTC placebo.
Arm B – Daily oral TDF/FTC (300/200 mg fixed-dose combination tablets) and IM placebo at two time points 4 weeks apart and every 8 weeks thereafter (matching vehicle, identical volume as active injectable product in Arm A).
This step will continue until the required number of endpoints is reached.

A participant that becomes HIV-infected during Step 2 of the study will permanently discontinue study product, be placed on immediate suppressive ART, and be followed for 52 weeks after their last injection, after which their participation in the study will end and they will be transitioned to continued HIV-related care.

Step 3:
Both arms: Open-label daily oral TDF/FTC no later than 8 weeks after the last injection (in order to cover the pharmacokinetic (PK) tail for Arm A participants), for up to 48 weeks.
Participants will then transition to locally-available HIV prevention services, including services for PrEP, if available.
A participant with confirmed HIV infection during Step 3 will be followed at least for the duration of Step 3.

STATUS: This study is still active, but is closed to new enrollments. Preliminary results can be reviewed at this link.

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RELEVANCE: Development of effective vaccines to protect individuals against HIV is a challenging and growing public health priority. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV globally.

DESCRIPTION: The HVTN 302 study is a phase 1 clinical trial looking to evaluate the safety and immunogenicity (how the immune system responds) to three different HIV trimer mRNA vaccines in healthy, HIV uninfected adults.

STATUS: This study is currently active. We have reached full enrollment and are not recruiting additional participants.

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RELEVANCE: Methamphetamine (MA) use is common among MSM and is an important driver of the HIV/STI epidemic. Understanding the biological and behavioral risk factors that drive ongoing HIV/STI transmission among MA-using MSM is critical to designing potent HIV prevention interventions. Prevalence of MA use is substantially higher among MSM (5.9% among HIV-negative MSM and 12.3% among MSM living with HIV) than the general population (0.7%) (2,3), with a 707% increase in MA-related mortality in Los Angeles County over the past decade. MA use is associated with increased risk for HIV/STI acquisition and impaired HIV virologic control. Lack of HIV virologic control among HIV-positive MA-using MSM, combined with increased HIV/STI prevalence within their sexual networks, contributes to ongoing HIV/STI transmission. As MA use is associated with high-risk behavior, it is important to study the impacts of MA use on the biological and behavioral factors that are driving HIV/STI transmission among MSM.

DESCRIPTION: This study will evaluate whether methamphetamine use and/or sexually transmitted infections influence levels of inflammatory markers (cytokines) in the blood and in the rectum. The study uses contingency management and will include visits three times a week over 8 weeks. Participants will also be asked to complete surveys, provide samples (blood samples and rectal swabs), and have urine tested for the presence of drugs. They will also be offered a prescription for HIV pre-exposure prophylaxis at enrollment.

STATUS: This study is currently active and enrolling participants at the UCLA Vine Street Clinic.

Click here for more information.

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RELEVANCE: SARS-CoV-2 is the virus that causes the disease called COVID-19, short for “Coronavirus Disease of 2019”. Finding an effective vaccine for COVID-19 is one of several steps being taken to end this global pandemic.

DESCRIPTION: The purpose of this study is to test Moderna’s vaccine candidate (mRNA-1273) to see if it can prevent illness if people are exposed to the SARS-CoV-2 virus in their everyday lives. This vaccine is not made from the SARS-CoV-2 virus. It is made from messenger ribonucleic acid (mRNA), a genetic code that tells cells how to make protein, which helps the body’s immune system make antibodies that can fight the virus. The vaccine cannot cause COVID-19 infection. This Phase 3 trial is being conducted at multiple clinic sites across the U.S. with a goal of enrolling 30,000 patients. Trial participants will receive 2 injections, approximately 28 days apart and will complete regular follow ups over the course of two years via phone calls, on-line surveys and additional in-person visits.

STATUS: This study is still active, but no longer enrolling new patients. Results of an interim analysis can be found here: https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy.

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RELEVANCE: Stimulant use, especially among men who have sex with men (MSM) in Los Angeles County (LAC) is common.  Stimulant drug use, particularly methamphetamine use, is a significant factor in the progression of HIV and STI among MSM in LAC.  Non-white MSM are at greatest risk of HIV infection in the United States.  Analyses of drug use are needed among diverse samples of MSM in order to understand the impact of drug use on the HIV epidemic over time and to address the effect of long-term drug use patterns on uptake and adherence to treatment and prevention of the disease.

DESCRIPTION: The goal of this project is to assemble a cohort of minority men who have sex with men (MMSM) who actively use substances and engage transmission risks. This will facilitate studies on interactions between substance use and HIV progression and/or transmission. This important cohort of MMSM will characterize: (i) effects substance use on risk behaviors, and network dynamics in exposed and infected MMSM on acquisition of HIV and other sexually transmitted infections (STIs: gonorrhea, Chlamydia, syphilis, Hepatitis C (HCV)); and (ii) the extent to which substance use in MMSM facilitates behaviors that transmit HIV compared to non-drug using MMSM.

STATUS: This study is now enrolling. For more information, visit the study website at http://www.theMStudy.org.

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RELEVANCE: Methamphetamine (MA) is more prevalent than many other drugs, including opioids, with 37 million users of MA and amphetamine worldwide and 1.4 million past-year users in the U.S. alone in 2016. The number of MA poisoning deaths has steadily risen in recent years, from >3,700 in 2014 to 10,333 in 2017. Importantly, MA has been recognized as contributing substantially to the U.S. opioid crisis, with about half of MA poisoning deaths also caused by opioids. In the U.S., the annual economic cost of MA use is estimated to be $23.4 billion and use is strongly associated with HIV transmission. There are no FDA-approved pharmacologic treatments for MA use disorder, a major gap in addiction medicine, especially because behavioral interventions alone have limited efficacy and would likely benefit from adjunctive pharmacologic therapy.

 

DESCRIPTION: Previous randomized, placebo-controlled, double-blind trials have demonstrated a net reduction in MA positive urines in participants given mirtazapine. Before moving on to a larger trial, the FDA has requested additional data on the effects mirtazapine on those individuals using both MA and opioids. This drug-drug interaction (DDI) study will provide that data.

 

STATUS: This study is currently enrolling. Please call 323-461-3106 for more information.

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RELEVANCE: The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that there were 1.7 million new HIV infections in 2019, despite efforts to improve HIV testing, linkage to treatment, and prevention. Persistent disparities exist in ongoing HIV incidence in Black, Hispanic/LatinX MSM and TGW populations, with the greatest disparities in Black transgender women in the U.S. and with continued low uptake of PrEP in these disproportionately affected populations globally. These barriers clearly highlight the need for additional PrEP options that may address disparities to PrEP uptake.

DESCRIPTION: Twice a year injections of the medication Lenacapavir have the potential to provide an additional option for populations at risk of HIV acquisition. Lenacapavir can help address substantial existing PrEP barriers including requirements for daily adherence, stigma and concerns about disclosure and discrimination or other social harms, oral medication-associated adverse events, and challenges with access to health care providers in overburdened health systems or in geographical PrEP deserts. Thus, it has the potential to increase the uptake of, adherence to, and thereby the scalability of PrEP in those populations most disproportionately affected by HIV, which will contribute to the overarching goal of ending the epidemic. The primary objective of this study is to evaluate the efficacy of Lenacapavir in preventing the risk of HIV infection.

STATUS: This study is currently active and enrolling participants at the UCLA Vine Street Clinic. Click here for more information.

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According to a 1992 study published in the Journal of Sexually Transmitted Diseases, using a condom makes sex 10,000 times safer than not using a condom. The UCLA Vine Street Clinic has partnered with LA County to provide free condoms to the public. For more information, visit http://lacondom.com/find-free-condoms/

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About

CBAM is a multidisciplinary center that seeks to advance the prevention and treatment of chronic illnesses, especially in communities with health disparities. As part of the UCLA Department of Family Medicine, CBAM works at the intersection of academia and community with a focus on treating addictions and preventing the spread of HIV.

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