Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
- Conditions
- HivOpioid Use Disorder
- Interventions
- Behavioral: community-friendly health recovery programDrug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
- Registration Number
- NCT05669534
- Lead Sponsor
- University of Connecticut
- Brief Summary
The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).
- Detailed Description
Participants will be randomized to one of 16 conditions. In addition to receiving the Core Components of the CHRP behavioral intervention, participants will receive one of the sixteen combinations of four compensatory components that show promise in terms of enhancing the ability to process and utilize HIV prevention content (see conceptual figure above), and that are not currently part of CHRP. The Attention Component includes: (a) Increasing frequency of sessions (more than once per week); (b) Distributed practice (spreading out information across sessions); (c) More structured sessions (well-organized objectives shared with patients); (d) Introducing new information during closure (foreshadow content of next session). The Executive Function Component includes the following strategies: (a) Associating behavior with situational cues (anticipate risky situations); (b) Linking actions to a triggering cue (storytelling techniques using imagery); (c) Planning (identify and organize steps required to meet goal) and (d) Valuing future events (recognize the benefits of drug treatment). Similarly, the Memory Component involves: (a) Memory aids (reminders and cues to be used between sessions); (b) Summarizing/reiterating information (frequent review throughout sessions); (c) Prospective memory (emphasize routine, develop cues, elaborate on positive behaviors); and (d) Environmental engineering (prepare for adverse events). Lastly, the Information Processing Component includes: (a) Mixed methods of presentation (verbal, visual, and hands-on); (b) Simple language (clear, concrete examples aligned with health literacy level); (c) Present content slowly (allow extra time for responses); and (d Immediate feedback following assessment (oral/ written).Of particular note, the investigators are using this framework to examine all combinations of these components (rather than merely testing all four) to promote ecological validity and future implementation. Specifically, our approach will help determine the most resource-efficient intervention, as there are many barriers to adding components to standard of care in these clinical settings. For example, if components targeting only two domains can produce equivalent outcomes as components targeting four, the former would be identified as preferred
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 256
- being 18 years or older
- meeting DSM-V criteria for opioid dependence and being newly prescribed and adherent to Medication for Opioid Use Disorder (e.g., methadone, buprenorphine) at the APT Foundation, Inc.
- showing mild cognitive impairment based on the Montreal Cognitive Assessment (MoCA) screening
- having initiated Pre-Exposure Prophylaxis (PrEP) within the past week
- confirming HIV-negative status through proof of PrEP prescription
- reporting unsafe injection drug use practices or unprotected sex within the past 3 months
- having a cell phone
- being able to read and understand in English
- unable to provide consent
- actively suicidal
- actively homicidal
- actively psychotic
- display MoCA scores suggestive of dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Condition 2 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components and Information Processing Components Condition 2 community-friendly health recovery program Standard CHRP Intervention Components and Information Processing Components Condition 4 community-friendly health recovery program Standard CHRP Intervention Components, Information Processing Components, and Memory Components Condition 8 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components Condition 10 community-friendly health recovery program Standard CHRP Intervention Components, Information Processing Components, and Attention Components Condition 11 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Memory Components, and Attention Components Condition 14 community-friendly health recovery program Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components Condition 13 community-friendly health recovery program Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components Condition 13 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components Condition 1 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components Condition 9 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components and Attention Components Condition 3 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components and Memory Components Condition 4 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Information Processing Components, and Memory Components Condition 3 community-friendly health recovery program Standard CHRP Intervention Components and Memory Components Condition 5 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Executive Functioning Components Condition 6 community-friendly health recovery program Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components Condition 8 community-friendly health recovery program Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components Condition 9 community-friendly health recovery program Standard CHRP Intervention Components and Attention Components Condition 1 community-friendly health recovery program Standard CHRP Intervention Components Condition 6 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components Condition 7 community-friendly health recovery program Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components Condition 7 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components Condition 10 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Information Processing Components, and Attention Components Condition 11 community-friendly health recovery program Standard CHRP Intervention Components, Memory Components, and Attention Components Condition 12 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components Condition 15 community-friendly health recovery program Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components Condition 16 community-friendly health recovery program Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components Condition 5 community-friendly health recovery program Standard CHRP Intervention Components, Executive Functioning Components Condition 12 community-friendly health recovery program Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components Condition 16 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components Condition 14 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components Condition 15 Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
- Primary Outcome Measures
Name Time Method Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) PrEP adherence DBS measured at the 9-month post-intervention follow-up Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via self-report scale PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Pre-Exposure Prophylaxis Adherence via pharmacy refill data PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
- Secondary Outcome Measures
Name Time Method HIV risk behaviors questionnaire HIV risk behaviors measured at the 9-month post-intervention follow-up Self-report oof "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
HIV prevention IMB model constructs questionnaire HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up self report of (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
Trial Locations
- Locations (1)
APT Foundation
🇺🇸New Haven, Connecticut, United States