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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hiv, Opioid Use Disorder

Intervention / Treatment
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* Behavioral: community-friendly health recovery program
* Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Multiphase Optimization Strategy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Condition 1<br>Standard CHRP Intervention Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 2<br>Standard CHRP Intervention Components and Information Processing Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 3<br>Standard CHRP Intervention Components and Memory Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 4<br>Standard CHRP Intervention Components, Information Processing Components, and Memory Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 5<br>Standard CHRP Intervention Components, Executive Functioning Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 6<br>Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 7<br>Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 8<br>Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 9<br>Standard CHRP Intervention Components and Attention Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 10<br>Standard CHRP Intervention Components, Information Processing Components, and Attention Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 11<br>Standard CHRP Intervention Components, Memory Components, and Attention Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 12<br>Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 13<br>Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 14<br>Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 15<br>Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|
| Experimental: Condition 16<br>Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components | Behavioral: community-friendly health recovery program<br>* Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.<br>* Other names: CHRP;Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis<br>* Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.<br>* Other names: PrEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) | Dried Blood Spots will test the amount of active PrEP components in the participants blood. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, people who inject drugs, cognitive dysfunction, pre-exposure prophylaxis, multiphase optimization strategy, medication for opioid use disorder, opioid use disorder