Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05669534

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Cognition Disorders Cognitive Dysfunction Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Narcotic-Related Disorders Neurocognitive Disorders Opioid Use Disorder Opioid-Related Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

APT Foundation

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Brian Sibilio, BS

CONTACT

[email protected]

2037814690

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

community-friendly health recovery program

Behavioral

Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.

Other names: CHRP

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Drug

Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.

Other names: PrEP

Primary outcomes

  1. Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)

    Time frame: PrEP adherence DBS measured at week 4

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  2. Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)

    Time frame: PrEP adherence DBS measured at the 3-month post-intervention follow-up

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  3. Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)

    Time frame: PrEP adherence DBS measured at the 6-month post-intervention follow-up

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  4. Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)

    Time frame: PrEP adherence DBS measured at the 9-month post-intervention follow-up

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  5. Pre-Exposure Prophylaxis Adherence via pharmacy refill data

    Time frame: PrEP adherence pharmacy refill data measured at week 4

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  6. Pre-Exposure Prophylaxis Adherence via pharmacy refill data

    Time frame: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  7. Pre-Exposure Prophylaxis Adherence via pharmacy refill data

    Time frame: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  8. Pre-Exposure Prophylaxis Adherence via pharmacy refill data

    Time frame: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  9. Pre-Exposure Prophylaxis Adherence via self-report scale

    Time frame: PrEP adherence pharmacy self report measured at week 4

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

  10. Pre-Exposure Prophylaxis Adherence via self-report scale

    Time frame: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

  11. Pre-Exposure Prophylaxis Adherence via self-report scale

    Time frame: PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

  12. Pre-Exposure Prophylaxis Adherence via self-report scale

    Time frame: PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

Secondary outcomes

  1. HIV risk behaviors questionnaire

    Time frame: HIV risk behaviors measured at Week 1

    Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.

  2. HIV risk behaviors questionnaire

    Time frame: HIV risk behaviors measured at Week 4

    Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.

  3. HIV risk behaviors questionnaire

    Time frame: HIV risk behaviors measured at the 3-month post-intervention follow-up

    Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.

  4. HIV risk behaviors questionnaire

    Time frame: HIV risk behaviors measured at the 6-month post-intervention follow-up

    Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.

  5. HIV risk behaviors questionnaire

    Time frame: HIV risk behaviors measured at the 9-month post-intervention follow-up

    Self-report oof "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.

  6. HIV prevention IMB model constructs questionnaire

    Time frame: HIV prevention IMB model constructs measured at Week 1

    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

  7. HIV prevention IMB model constructs questionnaire

    Time frame: HIV prevention IMB model constructs measured at Week 4

    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

  8. HIV prevention IMB model constructs questionnaire

    Time frame: HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up

    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

  9. HIV prevention IMB model constructs questionnaire

    Time frame: HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up

    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

  10. HIV prevention IMB model constructs questionnaire

    Time frame: HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up

    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

Other outcomes

  1. Drug Test via Urine toxicology

    Time frame: conducted at Week 1

    Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses

  2. Drug Test via Urine toxicology

    Time frame: conducted at twice weekly during the 4-week intervention phase

    Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses

  3. Drug Test via Urine toxicology

    Time frame: conducted at 3-month follow-up

    Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses

  4. Drug Test via Urine toxicology

    Time frame: conducted at 6-month follow-up

    Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses

  5. Drug Test via Urine toxicology

    Time frame: conducted at 9-month follow-up

    Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Sibilio, BS

CONTACT

[email protected]

2037814690

Tanya Adler, MS

CONTACT

[email protected]

2037814690

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Acronym: MOST

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 3, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.