Clinical trial NCT03282890: Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
Official title: Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
HIV/AIDS
Medication Adherence
Substance Abuse
Keywords: HIV
Substance Abuse
Pre-Exposure Prophylaxis
HIV Risk Behavior
Methadone Maintenance
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: APT Foundation, Inc.
First posted: 2017-09-14
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP adherence
timeFrame: Over a 9-month period
measure: HIV risk reduction behaviors
timeFrame: Over a 9-month period
Secondary outcomes:
measure: IMB measures related to PrEP adherence and HIV risk reduction
timeFrame: Over a 9-month period
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michael Copenhaver, PhD
role: PRINCIPAL_INVESTIGATOR
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