Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP

Overview

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

Interventions

• Behavioral community-friendly health recovery program
  Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
• Drug Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
  Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.

Primary outcome measures

• Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [Time frame: PrEP adherence DBS measured at week 4]
• Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [Time frame: PrEP adherence DBS measured at the 3-month post-intervention follow-up]
• Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [Time frame: PrEP adherence DBS measured at the 6-month post-intervention follow-up]
• Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [Time frame: PrEP adherence DBS measured at the 9-month post-intervention follow-up]
• Pre-Exposure Prophylaxis Adherence via pharmacy refill data [Time frame: PrEP adherence pharmacy refill data measured at week 4]
• Pre-Exposure Prophylaxis Adherence via pharmacy refill data [Time frame: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up]
• Pre-Exposure Prophylaxis Adherence via pharmacy refill data [Time frame: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up]
• Pre-Exposure Prophylaxis Adherence via pharmacy refill data [Time frame: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up]
• Pre-Exposure Prophylaxis Adherence via self-report scale [Time frame: PrEP adherence pharmacy self report measured at week 4]
• Pre-Exposure Prophylaxis Adherence via self-report scale [Time frame: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups]

Secondary outcome measures (10)

• HIV risk behaviors questionnaire [Time frame: HIV risk behaviors measured at Week 1]
• HIV risk behaviors questionnaire [Time frame: HIV risk behaviors measured at Week 4]
• HIV risk behaviors questionnaire [Time frame: HIV risk behaviors measured at the 3-month post-intervention follow-up]
• HIV risk behaviors questionnaire [Time frame: HIV risk behaviors measured at the 6-month post-intervention follow-up]
• HIV risk behaviors questionnaire [Time frame: HIV risk behaviors measured at the 9-month post-intervention follow-up]
• HIV prevention IMB model constructs questionnaire [Time frame: HIV prevention IMB model constructs measured at Week 1]
• HIV prevention IMB model constructs questionnaire [Time frame: HIV prevention IMB model constructs measured at Week 4]
• HIV prevention IMB model constructs questionnaire [Time frame: HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up]
• HIV prevention IMB model constructs questionnaire [Time frame: HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up]
• HIV prevention IMB model constructs questionnaire [Time frame: HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• unable to provide consent
• actively suicidal
• actively homicidal
• actively psychotic
• display MoCA scores suggestive of dementia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• APT Foundation — New Haven

Publications

• Mistler CB, Shrestha R, Gunstad J, Collins L, Madden L, Huedo-Medina T, Sibilio B, Copenhaver NM, Copenhaver M. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023 Jun 30;13(6):e071688. doi: 10.1136/bmjopen-2023-071688. PMID 37399447

Identifiers

NCT: NCT05669534 · H22-0121

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗