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
• Interventions: Other: CHRP-BB

• 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.

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Study Start: 2017-11-20
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

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

Arm && Interventions

Group	Intervention	Description
CHRP-BB	CHRP-BB	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).

Primary Outcome Measures

Name	Time	Method
PrEP adherence	Over a 9-month period	PrEP Adherence will be assessed with Dried Blood Spots (DBS) and by self-report using the visual analogue scale (VAS) and pharmacy refill data.
HIV risk reduction behaviors	Over a 9-month period	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.

Secondary Outcome Measures

Name	Time	Method
IMB measures related to PrEP adherence and HIV risk reduction	Over a 9-month period	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.

Trial Locations

Locations (1)

APT Foundation; 🇺🇸 New Haven, Connecticut, United States