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

Hiv Clinical Trial

— MOST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669534
• Other study ID #: H22-0121
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2023
• Source: University of Connecticut
• Contact: Brian Sibilio, BS
• Phone: 2037814690
• Email: brian.sibilio[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at Week 1
Other	Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at twice weekly during the 4-week intervention phase
Other	Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at 3-month follow-up
Other	Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at 6-month follow-up
Other	Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at 9-month follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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