Clinical trial NCT05669534: Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Official title: Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hiv
Opioid Use Disorder
Keywords: people who inject drugs
HIV
cognitive dysfunction
pre-exposure prophylaxis
multiphase optimization strategy
medication for opioid use disorder
opioid use disorder
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2023-01-03
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Multiphase Optimization Strategy
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
timeFrame: PrEP adherence DBS measured at week 4
measure: Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
timeFrame: PrEP adherence DBS measured at the 3-month post-intervention follow-up
measure: Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
timeFrame: PrEP adherence DBS measured at the 6-month post-intervention follow-up
measure: Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
timeFrame: PrEP adherence DBS measured at the 9-month post-intervention follow-up
measure: Pre-Exposure Prophylaxis Adherence via pharmacy refill data
timeFrame: PrEP adherence pharmacy refill data measured at week 4
measure: Pre-Exposure Prophylaxis Adherence via pharmacy refill data
timeFrame: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up
measure: Pre-Exposure Prophylaxis Adherence via pharmacy refill data
timeFrame: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up
measure: Pre-Exposure Prophylaxis Adherence via pharmacy refill data
timeFrame: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up
measure: Pre-Exposure Prophylaxis Adherence via self-report scale
timeFrame: PrEP adherence pharmacy self report measured at week 4
measure: Pre-Exposure Prophylaxis Adherence via self-report scale
timeFrame: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups
measure: Pre-Exposure Prophylaxis Adherence via self-report scale
timeFrame: PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups
measure: Pre-Exposure Prophylaxis Adherence via self-report scale
timeFrame: PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups
Secondary outcomes:
measure: HIV risk behaviors questionnaire
timeFrame: HIV risk behaviors measured at Week 1
measure: HIV risk behaviors questionnaire
timeFrame: HIV risk behaviors measured at Week 4
measure: HIV risk behaviors questionnaire
timeFrame: HIV risk behaviors measured at the 3-month post-intervention follow-up
measure: HIV risk behaviors questionnaire
timeFrame: HIV risk behaviors measured at the 6-month post-intervention follow-up
measure: HIV risk behaviors questionnaire
timeFrame: HIV risk behaviors measured at the 9-month post-intervention follow-up
measure: HIV prevention IMB model constructs questionnaire
timeFrame: HIV prevention IMB model constructs measured at Week 1
measure: HIV prevention IMB model constructs questionnaire
timeFrame: HIV prevention IMB model constructs measured at Week 4
measure: HIV prevention IMB model constructs questionnaire
timeFrame: HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up
measure: HIV prevention IMB model constructs questionnaire
timeFrame: HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up
measure: HIV prevention IMB model constructs questionnaire
timeFrame: HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up
Other outcomes:
measure: Drug Test via Urine toxicology
timeFrame: conducted at Week 1
measure: Drug Test via Urine toxicology
timeFrame: conducted at twice weekly during the 4-week intervention phase
measure: Drug Test via Urine toxicology
timeFrame: conducted at 3-month follow-up
measure: Drug Test via Urine toxicology
timeFrame: conducted at 6-month follow-up
measure: Drug Test via Urine toxicology
timeFrame: conducted at 9-month follow-up
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michael Copenhaver, PhD
role: PRINCIPAL_INVESTIGATOR
References: