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

June 12, 2026 updated by: Michael Copenhaver, University of Connecticut
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Condition 1
Standard CHRP Intervention Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 2
Standard CHRP Intervention Components and Information Processing Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 3
Standard CHRP Intervention Components and Memory Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 4
Standard CHRP Intervention Components, Information Processing Components, and Memory Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 5
Standard CHRP Intervention Components, Executive Functioning Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 6
Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 7
Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 8
Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 9
Standard CHRP Intervention Components and Attention Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 10
Standard CHRP Intervention Components, Information Processing Components, and Attention Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 11
Standard CHRP Intervention Components, Memory Components, and Attention Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 12
Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 13
Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 14
Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 15
Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP
Experimental: Condition 16
Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components
Behavioral: community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Other Names:
  • CHRP
Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Other Names:
  • PrEP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
PrEP adherence DBS measured at week 4
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.
PrEP adherence DBS measured at the 3-month post-intervention follow-up
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.
PrEP adherence DBS measured at the 6-month post-intervention follow-up
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.
PrEP adherence DBS measured at the 9-month post-intervention follow-up
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
PrEP adherence pharmacy refill data measured at week 4
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
PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up
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
PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up
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
PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up
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
PrEP adherence pharmacy self report measured at week 4
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
PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups
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
PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups
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
PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
HIV risk behaviors measured at Week 1
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.
HIV risk behaviors measured at Week 4
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.
HIV risk behaviors measured at the 3-month post-intervention follow-up
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.
HIV risk behaviors measured at the 6-month post-intervention follow-up
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.
HIV risk behaviors measured at the 9-month post-intervention follow-up
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
HIV prevention IMB model constructs measured at Week 1
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
HIV prevention IMB model constructs measured at Week 4
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
HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up
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
HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up
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
HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Drug Test via Urine toxicology
Time Frame: conducted at Week 1
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
conducted at Week 1
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
conducted at twice weekly during the 4-week intervention phase
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
conducted at 3-month follow-up
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
conducted at 6-month follow-up
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
conducted at 9-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Connecticut

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Copenhaver, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H22-0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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