Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs

PWUD remain a priority population as they represent a critical conduit for new HIV
infections, which are transmitted through preventable drug- and sex-related HIV risk
behaviors. Pre-Exposure Prophylaxis (PrEP) - the daily self-administration of antiretroviral
medication - has enormous potential to bolster primary HIV prevention outcomes among PWUD.
PrEP is a FDA-approved biomedical HIV prevention strategy recommended by the CDC and WHO for
key populations, including PWUD. Despite unequivocal evidence supporting PrEP, its scale-up
has been nearly absent among high risk PWUD. Moreover, adherence to PrEP is crucial if it is
to be effective with high risk individuals. Recent research, however, indicates that optimal
PrEP adherence may be compromised by neurocognitive impairment (NCI), particularly among
PWUD. Due to chronic drug use, related lifestyle experiences, and other health challenges,
many PWUD experience NCI to the extent that it impedes medication adherence, HIV risk
reduction, and treatment retention. In a recent HIV prevention trial, over a third of high
risk PWUD on opioid replacement therapy (ORT) had moderate to high levels of NCI and,
moreover, were less likely to reduce their HIV transmission risk vs. those without NCI. The
potentially disruptive impact of NCI must therefore be addressed when designing contemporary
intervention strategies targeting PWUD. Contemporary approaches must also be cost-effective
and usable in real-world treatment settings, such as methadone maintenance programs (MMPs)
where high risk PWUD are concentrated and can be readily reached with primary prevention. To
date, however, primary prevention efforts have largely relied on singular strategies (e.g.,
methadone or PrEP alone) with modest HIV risk reduction outcomes for PWUD. Instead, advancing
combination approaches capable of harnessing the synergy and efficiency possible via multiple
evidence-based strategies is most effective. This combination strategy is especially
important when intervening with high risk PWUD with NCI due to the potential decreased
effectiveness of PrEP when adherence is suboptimal, thereby necessitating behavioral
interventions that focus on reducing HIV risk and increasing PrEP adherence. Building on
promising preliminary work, the proposed trial will fill a critical void by testing an
integrated bio-behavioral approach that incorporates the use of PrEP with an evidence-based
behavioral approach and, using innovative strategies, enhances PrEP adherence and HIV risk
behavior in a manner that accommodates NCI among PWUD.

Inclusion Criteria:

- Meet DSM-V criteria for opioid-dependence and are enrolled in methadone maintenance
drug treatment at the APT Foundation, Inc.

- Were confirmed to be HIV-negative and started on PrEP in the past week

- Report unsafe injection drug use practices or unprotected sex within the past 3 months

- Have a cell phone

- Are able to read and understand the questionnaires, ACASI, and informed consent form

- Available for the full duration of the study with no anticipated circumstances
impeding participation (e.g., pending charges, jail term).

Exclusion Criteria:

- Have an untreated bipolar or psychotic disorder

- Are actively suicidal or homicidal as assessed by trained research staff under the
supervision of a licensed clinical psychologist

- Cannot speak English