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

Not Applicable

Completed

Conditions: HIV/AIDS
Risk Behavior
Substance Abuse
Medication Adherence

Registration Number: NCT03282890

Lead Sponsor: University of Connecticut

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 237

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pre-exposure Prophylaxis (PrEP) Adherence Behavior	This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.	The Pre-exposure prophylaxis (PrEP) adherence behavior scale is an 11-item categorical self-report measure designed to assess how confident a participant is about properly taking their PrEP medication (e.g., "How confident are you that you could make PrEP part of your daily routine?"). The scale requires participants to respond to each of the 11 items about adherence by selecting whether they are either 'Not at all confident', 'Somewhat confident', 'Moderately confident', 'Very confident', or 'Completely confident' about the behavior. The 11 items are summed to create a total score, with higher scores indicating a better PrEP adherence behavior outcome. The possible range of total scores is 0-44.

Secondary Outcome Measures

Name	Time	Method
HIV Risk Reduction Behavior	This was assessed immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.	HIV risk reduction behavior was assessed using a 4-item categorical self-report measure designed to assess the participant's self-efficacy about engaging in behaviors to reduce their HIV risk (e.g., 'How hard would it be for you to always use condoms or latex protection if you have oral, vaginal, or anal sex?"). The measure requires participants to select one of five possible responses for each of the four items, indicating whether a behavior would be either 'Very hard to do', 'Fairly hard to do', 'Neither hard nor easy to do', 'Somewhat easy to do', or 'Very easy to do'. Responses to the four items were summed and reversed to create a total score, with higher scores indicating a better HIV risk reduction outcome.The possible range of total HIV risk reduction behavior scores is 4 to 20.