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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Active Comparator | Standard CHRP Intervention Components |
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| Condition 2 | Experimental | Standard CHRP Intervention Components and Information Processing Components |
|
| Condition 3 | Experimental | Standard CHRP Intervention Components and Memory Components |
|
| Condition 4 | Experimental | Standard CHRP Intervention Components, Information Processing Components, and Memory Components |
|
| Condition 5 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| community-friendly health recovery program | Behavioral | Participants will receive 4 weekly 45 minute sessions HIV prevention sessions. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Test via Urine toxicology | Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses | conducted at Week 1 |
| Drug Test via Urine toxicology | Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Sibilio, BS | Contact | 2037814690 | brian.sibilio@uconn.edu | |
| Tanya Adler, MS | Contact | 2037814690 | tanya.adler@uconn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Copenhaver, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APT Foundation | Recruiting | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37399447 | Derived | 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. |
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Individual participant data that underlie the results will be available upon request.
Immediately following publication. No end date
Proposals should be directed to Michael.Copenhaver@uconn.edu To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009293 | Opioid-Related Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065129 | Pre-Exposure Prophylaxis |
| D056990 | Post-Exposure Prophylaxis |
| ID | Term |
|---|---|
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Multiphase Optimization Strategy
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| Condition 6 | Experimental | Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components |
|
| Condition 7 | Experimental | Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components |
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| Condition 8 | Experimental | Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components |
|
| Condition 9 | Experimental | Standard CHRP Intervention Components and Attention Components |
|
| Condition 10 | Experimental | Standard CHRP Intervention Components, Information Processing Components, and Attention Components |
|
| Condition 11 | Experimental | Standard CHRP Intervention Components, Memory Components, and Attention Components |
|
| Condition 12 | Experimental | Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components |
|
| Condition 13 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components |
|
| Condition 14 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components |
|
| Condition 15 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components |
|
| Condition 16 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components |
|
|
| Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis | Drug | Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention. |
|
|
| 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 |
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 |
| conducted at twice weekly during the 4-week intervention phase |
| Drug Test via Urine toxicology | Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses | conducted at 3-month follow-up |
| Drug Test via Urine toxicology | Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses | conducted at 6-month follow-up |
| Drug Test via Urine toxicology | Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses | conducted at 9-month follow-up |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |