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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
256
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
APT Foundation
New Haven, Connecticut, United States
RECRUITINGPre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame: PrEP adherence DBS measured at week 4
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame: PrEP adherence DBS measured at the 3-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame: PrEP adherence DBS measured at the 6-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame: PrEP adherence DBS measured at the 9-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Time frame: PrEP adherence pharmacy refill data measured at week 4
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Time frame: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Time frame: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Time frame: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via self-report scale
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Time frame: PrEP adherence pharmacy self report measured at week 4
Pre-Exposure Prophylaxis Adherence via self-report scale
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Time frame: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups
Pre-Exposure Prophylaxis Adherence via self-report scale
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Time frame: PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups
Pre-Exposure Prophylaxis Adherence via self-report scale
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Time frame: PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame: HIV risk behaviors measured at Week 1
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame: HIV risk behaviors measured at Week 4
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame: HIV risk behaviors measured at the 3-month post-intervention follow-up
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame: HIV risk behaviors measured at the 6-month post-intervention follow-up
HIV risk behaviors questionnaire
Self-report oof "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame: HIV risk behaviors measured at the 9-month post-intervention follow-up
HIV prevention IMB model constructs questionnaire
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
Time frame: HIV prevention IMB model constructs measured at Week 1
HIV prevention IMB model constructs questionnaire
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
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Time frame: HIV prevention IMB model constructs measured at Week 4
HIV prevention IMB model constructs questionnaire
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
Time frame: HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up
HIV prevention IMB model constructs questionnaire
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
Time frame: HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up
HIV prevention IMB model constructs questionnaire
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
Time frame: HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up