Trial Pairs PrEP With Behavioral Intervention to Prevent HIV in Drug Users

Yale University investigators are leading a trial that is testing a bio-behavioral intervention’s ability to improve pre-exposure prophylaxis (PrEP) adherence and reduce the risk of HIV acquisition in individuals with opioid dependency, a population experiencing new outbreaks of HIV.

New cases of hepatitis C and HIV among injection drug uses who share needles have been a growing concern in the public health community. According to the US Centers for Disease Control and Prevention (CDC), although the annual number of new HIV infections in people who inject drugs declined 32% from 2010 to 2014, the population accounted for 9% (3425) of the new 39,782 diagnoses of HIV and 13% (2431) of the 18,160 AIDS diagnoses in the United States in 2016. Access and use of services such as needle exchange programs to reduce syringe sharing and the risk of hepatitis C and HIV transmission remains low in people who use drugs (PWUD), note the investigators of an article recently published in the journal Contemporary Clinical Trials.

“PrEP scale-up in PWUD has been hampered due to concerns about poor adherence in this at-risk group,” the authors write, noting that high levels of neurocognitive impairment (NCI) from chronic drug use may contribute to the low PrEP adherence and reduce the benefit of HIV risk reduction intervention.

In an interview with Contagion^®, first author Roman Shrestha, PhD, explained that barriers between PWUD and PrEP use include limited awareness, lack of access to PrEP, need for near-perfect adherence to daily PrEP, need for multiple visits to get access to PrEP, and stigma.

Rather than offer a singular strategy for HIV prevention, the investigators developed an intervention integrating both behavioral and biomedical strategies known as the Bio-behavioral Community-Friendly Health Recovery Program (CHRP-BB) to address the lack of HIV prevention strategies for PWUD. “The proposed study aims to test the CHRP-BB intervention, an integrated approach that incorporates biomedical (PrEP) and behavioral strategies, to improve adherence to PrEP and reduce HIV risk behaviors in PWUD,” explained Shrestha. “We’re recruiting high-risk, HIV-negative opioid-dependent PWUD who are enrolled in methadone clinic.”

Recruiting is currently ongoing at APT Foundation, Inc, in New Haven, Connecticut, said Shrestha, and the study team expects to enroll 300 participants during the course of a 5-year study. Both the experimental group and a control group will include participants enrolled in a methadone maintenance program (MMP). The CHRP-BB intervention combines PrEP administration along with evidence-based behavioral intervention to reduce HIV risk behavior for HIV-negative, opioid-dependent PWUD receiving treatment. Participants enrolled in the 8-week CHRP-BB will attend group sessions on HIV risk reduction and PrEP adherence, covering topics such as drug and sex risk reduction strategies, with assessment follow-ups at weeks 20, 32, and 44 following intervention.

“Results from our pilot work showed excellent feasibility in terms of incorporating the bio-behavioral intervention into the MMP and promising adherence to PrEP and HIV risk-reduction outcomes,” note the authors.

Recruitment for the CHRP-BB trial began in 2017 and will continue until 2021. Shrestha adds that the study team recently finished a study on interest among PWUD in long-acting HIV prophylaxis products as an alternative to a once-daily PrEP pill, which found that the majority of the PWUD prefer the long-acting products to daily oral PrEP.