News

UCLA: Addressing the Opioid Crisis

Fielding School of Public Health Magazine

Published May 2019

AMERICA’S OPIOID EPIDEMIC, well into its third decade, continues to devastate individuals, families and communities.

In March, the U.S. Centers for Disease Control and Prevention (CDC) described what it calls the third wave of the public health crisis — a crisis that claimed nearly 400,000 lives nationally between 1999 and 2017. What started in the 1990s with prescription opioid painkillers was followed by a second wave, beginning in 2010, which was marked by increased heroin use as many who had become addicted to prescription pills began to seek out a substitute that was cheaper and easier to obtain. The third wave, traced to late 2013, is characterized by significant increases in overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl.

If nothing is done, the CDC report concluded, as many as 650,000 more people will die from opioid overdoses in the next decade — more than the population of Baltimore.

“The opioid epidemic is affecting people across the spectrum — young and old, regardless of ethnicity or socioeconomic status,” says Dr. Pamina Gorbach, professor of epidemiology at the Fielding School. “Along with the terrible problem of overdose deaths, there can be long-term disabilities caused from the experience of being addicted, worsened for those who overdose repeatedly.”

Read more

$5M NIDA grant sparks collaboration of cohorts to study intersection of HIV and substance abuse

Millions of specimens and data elements become available to researchers with approved concepts

Published September 2017

IN RESPONSE TO THE STRONG NEED FOR INNOVATION, data sharing and collaboration on HIV/AIDS and substance abuse research, the National Institute of Drug Abuse (NIDA) has funded a $5 million U24 coordinating center grant. Having extensive experience in the management and organization of HIV and substance abuse research, Professor Pamina Gorbach (MHS, DrPH) of the UCLA Fielding School of Public Health (FSPH) Department of Epidemiologywas awarded the five-year grant as lead Principal Investigator with Suzanne Siminski (MS, MBA), director of Frontier Science’s Amherst, New York Office as co-PI. “NIDA-funded HIV cohorts have been collecting well characterized data elements from key populations since the outset of the HIV/AIDS epidemic. We are excited to lead the first effort to link these rich datasets to enhance access of them to a broad range of researchers and leverage the cohorts’ combined sample size of approximately 12,000 participants. There is great opportunity to build on and expand the science on substance use and HIV with cross-cohort research efforts and we are so excited to create the infrastructure to do so utilizing a team science approach,” says Gorbach, pointing to the establishment of their data coordinating center: the Collaborating Consortium of Cohorts NIDA Producing Opportunities (C3PNO).

The Fielding School-based data coordinating center will facilitate high impact science by connecting researchers across NIDA-funded cohorts and developing a virtual biorepository that compiles data ranging from state-of-the-art bioinformatics on laboratory specimens to innovative assessment of behaviors. Since the beginning of the HIV epidemic, NIDA has created a unique group of researchers throughout North America to study how the virus affects and is affected by substance use. The NIDA-funded researchers’ work covers the role of drug use on the HIV epidemic, the importance of co-morbidities such as Hepatitis C, cardiovascular disease and more recently metabolic diseases. The data will be aggregated and maintained by the C3PNO center, which in turn will serve as a virtual clearinghouse to make the data elements and descriptions of biospecimens available to internal and external investigators. By partnering with Frontier Science, the center’s bioinformatics capacity is uniquely capable in the area of specimen data management. Applying Frontier Science’s high-end propriety file formatting software will ease the data sharing of millions of specimen across the cohorts and with the academic community and launch a virtual repository similar to the one they created for the National Institute of Allergy and Infectious Disease HIV Research Networks.

The center already has a vast set of data elements ready to share, including 40,000 specimens that were collected under the 2009-2012 NIDA-funded HIV/AIDS Study of primarily African-American and Latino Men who Have Sex with Men cohort known as mSTUDY (Minority Men Who have Sex With Men Cohort at UCLA Linking Infections Noting Effects [U01DA036267]), led by Gorbach and Steve Shoptaw, PhD, professor of family medicine at the UCLA David Geffen School of Medicine. As one of the ten cohorts that are part of C3PNO, mSTUDY’s success in the enrollment and (93%) retention of participants, deposit and storage of specimen data, and production of multiple spin-off research studies provides an insiders perspective to the leadership of C3PNO. Over the course of mSTUDY’s existence, 234 people who are HIV-positive, 239 HIV-negative and 4 people who seroconverted and consented to providing blood, hair, nail, saliva, and rectal fluid specimens for future analyses. These will be contributed to C3PNO’s cross-cohort virtual repository along with clinical, behavioral, and demographic data available for analysis.

Investigators who are interested in addressing questions specific to HIV and substance use in at-risk and HIV positive populations can submit data requests and receive more information by contacting Dr. Pamina Gorbach(pgorbach@ucla.edu) or Amy Ragsdale, Administrative Director of C3PNO (aeragsdale@mednet.ucla.edu). More information can be found on the C3PNO website.

The Coordinating Center for the HIV/AIDS and Substance Use Cohorts Program (U24) grant was awarded by the National Institutes of Health’s National Institute on Drug Abuse, and awarded to the University of California, Los Angeles with Dr. Pamina Gorbach as Project Principle Investigator.

Policy makers’ inaction is leading people to take PrEP ‘in the wild’ 

Jerome Galea presenting at HIVR4P. Photo by Roger Pebody / aidsmap.com
Roger Pebody

Published: 19 October 2016

An increasing number of gay men and others at risk of HIV are seeking to protect their health with PrEP (pre-exposure prophylaxis), but the lack of PrEP provision and lack of regulatory approval in many countries is leading people to take PrEP without medical supervision and on an ad-hoc basis. This will undermine the safety and effectiveness of PrEP, Jerome Galea said as he presented results of the PrEP in the Wild survey to the HIV Research for Prevention (HIVR4P 2016) conference in Chicago yesterday.

“The official authorities are playing catch up and failing in their duty to protect public health,” commented the authors of a separate report on PrEP Access in Europe.

The PrEP in the Wild researchers wanted to gain a better understanding of the characteristics of PrEP users and of their practices, to inform the implementation of PrEP. The internet survey recruited a convenience sample of people who responded to recruitment on social media, through advocacy groups and on websites such as aidsmap.com.

The survey was launched in February 2016 and remains open to new participants. Interim results, with data up to the end of July, were presented.

The survey was completed by 262 PrEP users as well as 52 ‘frustrated users’ – individuals who had been unable to obtain PrEP at all. The vast majority of respondents were gay men. One quarter had a primary partner who was living with HIV.

While there were some responses from all parts of the world, most participants came from Western countries in which there has been PrEP activism, including the UK (90 respondents), the US (48), Australia (31) and France (13).

People who had been able to get hold of PrEP had a variety of motivations for use – and individuals often expressed more than one. They included wanting to ‘let go’ during sex (80%), to facilitate sex with partners of an unknown HIV status or partners who said they were HIV negative (76%), because they preferred sex without a condom (71%), because of fear of HIV (67%), as a back-up for condom use (48%), to facilitate sex with HIV-positive partners (47%), to use during a sex party (43%) and because a sexual partner preferred not to use condoms (27%).

Only 13% had been advised to use PrEP by a health professional.

People were resourceful in the ways they obtained PrEP. Just over half ordered generic medicines online, without a prescription. (This may partly reflect the strong participation in the survey of people living in the UK and Australia; importing medicines is legal in these countries but it is not in many others.)

A third obtained pills from a friend or someone they knew. This could be medicines that were prescribed for HIV treatment and which were no longer needed; some HIV-positive patients may have also obtained extra pills by stating that they had “lost their prescription”. One in five obtained medications for use as post-exposure prophylaxis (PEP) but used some of them as pre-exposure prophylaxis (PrEP).

Others ordered online with a prescription, went to a retail pharmacy with a prescription or obtained them in another country.

Whereas 192 people saw a medical provider before starting PrEP, 62 did not. Among those who began PrEP without medical consultation, many omitted key procedures including kidney function monitoring (only done by 29%), HIV testing (done by 87%) and sexual health counselling (25%).

Most people were using either Truvada or a generic equivalent. While 5% did report using Atripla (which includes efavirenz alongside tenofovir disoproxil fumarate and emtricitabine), few people reported using other antiretrovirals.

One in five were following non-daily dosing. For some individuals this may reflect genuine choice, but for others it probably reflects the cost and difficulty of getting medication. Around a third of those aiming for daily dosing in fact had interruptions in their use. One in seven had shared pills with others.

The 52 respondents who couldn’t obtain PrEP cited a number of barriers, including its cost (mentioned by 60%), doctors’ refusal or inability to prescribe PrEP (50%) and importing PrEP being against the law in their country (35%).

“PrEP is not a DIY intervention,” commented Jerome Galea. He said that for PrEP to be safe and effective, regular medical monitoring and sexual health counselling is required. It is particularly important that the drugs are not taken after HIV seroconversion, which risks the development of drug resistance.

These problems were also described in PrEP Access in Europe, a report by the PrEP in Europe Initiative (a coalition of HIV organisations including NAM) that was launched at the conference. There is anecdotal evidence from countries across Europe of gay men obtaining PrEP in the ways described above.

In some countries, HIV doctors are prescribing Truvada off-label to small numbers of affluent HIV-negative people who can pay the full cost of the drug (around €400 or €500 a month). In countries with more restrictive policies or attitudes, individuals are smuggling drugs from other countries or obtaining them in underhand ways, as these respondents described:

“The only legal way to do this is to travel to the UK and bring the pills with you in your own luggage. That’s quite a barrier, so people are asking friends in the UK to receive the order and send on privately, or using parcel forward delivery services that use a UK PO box then forward the parcel to Germany from there.”

“There are anecdotal stories about some people living with HIV giving their Truvada to negative friends and asking for an extra bottle saying they have lost it. It is possible this is happening, but at a very small scale, as it would be noticed by the clinic if it were on larger scale. We only have one clinic and pharmacy with HIV drugs in Croatia.”

“We did hear stories of people selling Truvada on a party bus coming from Paris going to Brussels to a gay party.”

“Without official PrEP approval and roll-out within health care and community settings, many gay men will end up taking a few pills of Truvada without knowing their HIV status, STI status, renal health and risk factors,” the authors comment. “Many of them may take PrEP needlessly, or worse, within an acute HIV infection phase. These men may also be vulnerable to being sold counterfeit versions of Truvada as a black market emerges.”

The PrEP in Europe Initiative calls on European governments to make PrEP available to populations at imminent risk of HIV, as a matter of urgency.

References

Galea J et al. “PrEP in the Wild” – Preliminary Results from a Global Survey on “Informal” PrEP Use in Settings where it is Approved and where it is Not. HIV Research for Prevention (HIVR4P) 2016 conference, Chicago, abstract PD04.04LB, 2016.

PrEP in Europe Initiative. PrEP Access in Europe, 2016.

The PrEP in the Wild survey is still open and would like to hear from other people taking PrEP in these circumstances.

24,454 Comments