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

Primary Purpose

Hiv, Opioid Use Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
community-friendly health recovery program
Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hiv focused on measuring people who inject drugs, HIV, cognitive dysfunction, pre-exposure prophylaxis, multiphase optimization strategy, medication for opioid use disorder, opioid use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • APT FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Condition 9

Condition 10

Condition 11

Condition 12

Condition 13

Condition 14

Condition 15

Condition 16

Arm Description

Standard CHRP Intervention Components

Standard CHRP Intervention Components and Information Processing Components

Standard CHRP Intervention Components and Memory Components

Standard CHRP Intervention Components, Information Processing Components, and Memory Components

Standard CHRP Intervention Components, Executive Functioning Components

Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components

Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components

Standard CHRP Intervention Components and Attention Components

Standard CHRP Intervention Components, Information Processing Components, and Attention Components

Standard CHRP Intervention Components, Memory Components, and Attention Components

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components

Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components

Outcomes

Primary Outcome Measures

Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
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
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
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
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

Secondary Outcome Measures

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 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 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 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 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 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 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 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 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 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

Full Information

First Posted
December 5, 2022
Last Updated
June 12, 2023
Sponsor
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT05669534
Brief Title
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Acronym
MOST
Official Title
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
Multiphase Optimization Strategy
Masking
Participant
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Active Comparator
Arm Description
Standard CHRP Intervention Components
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components and Information Processing Components
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components and Memory Components
Arm Title
Condition 4
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Information Processing Components, and Memory Components
Arm Title
Condition 5
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Executive Functioning Components
Arm Title
Condition 6
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components
Arm Title
Condition 7
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components
Arm Title
Condition 8
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components
Arm Title
Condition 9
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components and Attention Components
Arm Title
Condition 10
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Information Processing Components, and Attention Components
Arm Title
Condition 11
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Memory Components, and Attention Components
Arm Title
Condition 12
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components
Arm Title
Condition 13
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components
Arm Title
Condition 14
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
Arm Title
Condition 15
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
Arm Title
Condition 16
Arm Type
Experimental
Arm Description
Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components
Intervention Type
Behavioral
Intervention Name(s)
community-friendly health recovery program
Other Intervention Name(s)
CHRP
Intervention Description
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Intervention Type
Drug
Intervention Name(s)
Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Other Intervention Name(s)
PrEP
Intervention Description
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Primary Outcome Measure Information:
Title
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Description
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time Frame
PrEP adherence DBS measured at week 4
Title
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Description
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
Title
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Description
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
Title
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Description
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
Title
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Description
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
Title
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Description
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
Title
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Description
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
Title
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Description
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
Title
Pre-Exposure Prophylaxis Adherence via self-report scale
Description
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
Title
Pre-Exposure Prophylaxis Adherence via self-report scale
Description
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
Title
Pre-Exposure Prophylaxis Adherence via self-report scale
Description
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
Title
Pre-Exposure Prophylaxis Adherence via self-report scale
Description
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
Secondary Outcome Measure Information:
Title
HIV risk behaviors questionnaire
Description
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
Title
HIV risk behaviors questionnaire
Description
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
Title
HIV risk behaviors questionnaire
Description
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
Title
HIV risk behaviors questionnaire
Description
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
Title
HIV risk behaviors questionnaire
Description
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
Title
HIV prevention IMB model constructs questionnaire
Description
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
Title
HIV prevention IMB model constructs questionnaire
Description
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 4
Title
HIV prevention IMB model constructs questionnaire
Description
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
Title
HIV prevention IMB model constructs questionnaire
Description
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
Title
HIV prevention IMB model constructs questionnaire
Description
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
Other Pre-specified Outcome Measures:
Title
Drug Test via Urine toxicology
Description
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time Frame
conducted at Week 1
Title
Drug Test via Urine toxicology
Description
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time Frame
conducted at twice weekly during the 4-week intervention phase
Title
Drug Test via Urine toxicology
Description
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time Frame
conducted at 3-month follow-up
Title
Drug Test via Urine toxicology
Description
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time Frame
conducted at 6-month follow-up
Title
Drug Test via Urine toxicology
Description
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time Frame
conducted at 9-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Sibilio, BS
Phone
2037814690
Email
brian.sibilio@uconn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tanya Adler, MS
Phone
2037814690
Email
tanya.adler@uconn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Copenhaver, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Sibilio, BS
Phone
203-781-4690
Email
brian.sibilio@uconn.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results will be available upon request.
IPD Sharing Time Frame
Immediately following publication. No end date
IPD Sharing Access Criteria
Proposals should be directed to Michael.Copenhaver@uconn.edu To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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