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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse

Intervention / Treatment
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* Other: CHRP-BB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHRP-BB<br>Patients assigned to the CHRP-BB will receive a weekly HIV risk reduction and PrEP adherence group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. It is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP-BB, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction and PrEP adherence. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). | Other: CHRP-BB<br>* The CHRP-BB intervention is a theory-based, manual-guided, HIV risk reduction and PrEP adherence intervention. It is an integrated evidence-based intervention that uses a coping skills training approach to primary prevention and is delivered in a small group modality by two trained intervention facilitators using a motivational enhancement therapeutic style to address high risk drug- and sex-related HIV risk behaviors and PrEP adherence. Importantly, the CHRP-BB intervention includes specific behavioral and mHealth strategies designed and tested to accommodate difficulties stemming from moderate to severe neuro-cognitive impairment (NCI).<br>|
| No Intervention: Control Condition<br>The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP adherence | PrEP Adherence will be assessed with Dried Blood Spots (DBS) and by self-report using the visual analogue scale (VAS) and pharmacy refill data. | Over a 9-month period | 
| HIV risk reduction behaviors | A self-reported assessment will measure several aspects of HIV risk-taking behaviors, including a measurement of any high risk behavior (sexual or injection-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors. Any risk behavior will be dichotomously parsed as those who have engaged in HIV transmission risk behaviors with those of unknown or HIV negative status. Urine toxicology tests will also be used to collect substance use data. | Over a 9-month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMB measures related to PrEP adherence and HIV risk reduction | Data collected at all assessment points will include our measure of IMB model constructs, including (a) Information - HIV risk- and PrEP-related knowledge; (b) Motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) Behavioral Skills - PrEP adherence skills and HIV risk reduction skills; and (d) Behavioral Outcomes - HIV risk and HIV risk reduction behaviors and PrEP adherence. | Over a 9-month period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Substance Abuse, Pre-Exposure Prophylaxis, HIV Risk Behavior, Methadone Maintenance