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

HIV/AIDS Clinical Trial

— CHRP-BB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282890
• Other study ID #: H17-200
• Secondary ID: R01DA044867
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: July 1, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS
• Medication Adherence
• Risk Behavior
• Substance Abuse
• Substance-Related Disorders

Intervention

Other:
• CHRP-BB
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).

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	APT Foundation, Inc., National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (11)

Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4. — View Citation

Copenhaver MM, Lee IC, Baldwin P. A randomized controlled trial of the community-friendly health recovery program (CHRP) among high-risk drug users in treatment. AIDS Behav. 2013 Nov;17(9):2902-13. doi: 10.1007/s10461-013-0539-4. — View Citation

Copenhaver MM, Lee IC, Margolin A. Successfully integrating an HIV risk reduction intervention into a community-based substance abuse treatment program. Am J Drug Alcohol Abuse. 2007;33(1):109-20. doi: 10.1080/00952990601087463. — View Citation

Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455. — View Citation

Huedo-Medina TB, Shrestha R, Copenhaver M. Modeling a Theory-Based Approach to Examine the Influence of Neurocognitive Impairment on HIV Risk Reduction Behaviors Among Drug Users in Treatment. AIDS Behav. 2016 Aug;20(8):1646-57. doi: 10.1007/s10461-016-1394-x. — View Citation

Shrestha R, Altice F, Karki P, Copenhaver M. Developing an Integrated, Brief Biobehavioral HIV Prevention Intervention for High-Risk Drug Users in Treatment: The Process and Outcome of Formative Research. Front Immunol. 2017 May 11;8:561. doi: 10.3389/fimmu.2017.00561. eCollection 2017. — View Citation

Shrestha R, Altice FL, Huedo-Medina TB, Karki P, Copenhaver M. Willingness to Use Pre-Exposure Prophylaxis (PrEP): An Empirical Test of the Information-Motivation-Behavioral Skills (IMB) Model among High-Risk Drug Users in Treatment. AIDS Behav. 2017 May;21(5):1299-1308. doi: 10.1007/s10461-016-1650-0. — View Citation

Shrestha R, Huedo-Medina TB, Altice FL, Krishnan A, Copenhaver M. Examining the Acceptability of mHealth Technology in HIV Prevention Among High-Risk Drug Users in Treatment. AIDS Behav. 2017 Nov;21(11):3100-3110. doi: 10.1007/s10461-016-1637-x. — View Citation

Shrestha R, Karki P, Altice FL, Dubov O, Fraenkel L, Huedo-Medina T, Copenhaver M. Measuring Acceptability and Preferences for Implementation of Pre-Exposure Prophylaxis (PrEP) Using Conjoint Analysis: An Application to Primary HIV Prevention Among High Risk Drug Users. AIDS Behav. 2018 Apr;22(4):1228-1238. doi: 10.1007/s10461-017-1851-1. — View Citation

Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2. — View Citation

Shrestha R, Karki P, Huedo-Medina TB, Copenhaver M. Intent to Use Preexposure Prophylaxis (PrEP), HIV Risk Behaviors, and Self-Report Neurocognitive Symptoms by High-Risk Drug Users: A Mediation Analysis. J Assoc Nurses AIDS Care. 2017 Jul-Aug;28(4):612-621. doi: 10.1016/j.jana.2017.04.005. Epub 2017 Apr 19. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   University of Connecticut Institute for Collaboration on Health, Intervention, and Policy (InCHIP)