HivPhase 4MOSTNCT05669534
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
A Phase 4 study testing community-friendly health recovery program and Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis in people with Hiv and Opioid Use Disorder, run by University of Connecticut at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Opioid Use Disorder
- What is being tested?
- community-friendly health recovery program and Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to provide consent
- actively suicidal
- actively homicidal
- actively psychotic
- display MoCA scores suggestive of dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
APT Foundation
New Haven, Connecticut, 06519
Brian Sibilio, BS, 2037814690, brian.sibilio@uconn.edu
About this study
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).
Read the 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
- Conditions
- Hiv, Opioid Use Disorder
- Being tested
- community-friendly health recovery program, Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
- Keywords
- people who inject drugs, HIV, cognitive dysfunction, pre-exposure prophylaxis, multiphase optimization strategy, medication for opioid use disorder, opioid use disorder
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Opioid-Related Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community-friendly health recovery programBehavioural
Also called CHRP
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisDrug
Also called PrEP
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Active comparator | Standard CHRP Intervention Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 2 | Experimental | Standard CHRP Intervention Components and Information Processing Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 3 | Experimental | Standard CHRP Intervention Components and Memory Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 4 | Experimental | Standard CHRP Intervention Components, Information Processing Components, and Memory Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 5 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 6 | Experimental | Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 7 | Experimental | Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 8 | Experimental | Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 9 | Experimental | Standard CHRP Intervention Components and Attention Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 10 | Experimental | Standard CHRP Intervention Components, Information Processing Components, and Attention Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 11 | Experimental | Standard CHRP Intervention Components, Memory Components, and Attention Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 12 | Experimental | Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 13 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 14 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 15 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
| Condition 16 | Experimental | Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components Receives: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Measured: PrEP adherence DBS measured at week 4
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Measured: PrEP adherence DBS measured at the 3-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Measured: PrEP adherence DBS measured at the 6-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Measured: PrEP adherence DBS measured at the 9-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Measured: PrEP adherence pharmacy refill data measured at week 4
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Measured: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Measured: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Measured: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up
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
Measured: PrEP adherence pharmacy self report measured at week 4
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
Measured: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups
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
Measured: PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups
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
Measured: PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups
Secondary outcomes (10)
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.
Measured: HIV risk behaviors measured at Week 1
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.
Measured: HIV risk behaviors measured at Week 4
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.
Measured: HIV risk behaviors measured at the 3-month post-intervention follow-up
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.
Measured: HIV risk behaviors measured at the 6-month post-intervention follow-up
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.
Measured: HIV risk behaviors measured at the 9-month post-intervention follow-up
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
Measured: HIV prevention IMB model constructs measured at Week 1
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
Measured: HIV prevention IMB model constructs measured at Week 4
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
Measured: HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up
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
Measured: HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up
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
Measured: HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start1 Mar 2023
- Primary completionJan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Multiphase Optimization Strategy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Copenhaver, University of Connecticut
- Investigators
- Michael Copenhaver, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669534
- Sponsor's protocol ID
- H22-0121
- Acronym
- MOST
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results will be available upon request.
Publications
Mistler CB, Shrestha R, Gunstad J, Collins L, Madden L, Huedo-Medina T, Sibilio B, Copenhaver NM, Copenhaver M. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023 Jun 30;13(6):e071688. doi: 10.1136/bmjopen-2023-071688.
PubMed 37399447
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
- ClinicalTrials.gov ID
- NCT05669534
- Acronym / sponsor ID
- MOST / H22-0121
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
- Model description
- Multiphase Optimization Strategy
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Active comparator | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components |
| Condition 2 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components and Information Processing Components |
| Condition 3 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components and Memory Components |
| Condition 4 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Information Processing Components, and Memory Components |
| Condition 5 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Executive Functioning Components |
| Condition 6 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components |
| Condition 7 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Memory Components, and Executive Functioning Components |
| Condition 8 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components |
| Condition 9 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components and Attention Components |
| Condition 10 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Information Processing Components, and Attention Components |
| Condition 11 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Memory Components, and Attention Components |
| Condition 12 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components |
| Condition 13 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Executive Functioning Components, and Attention Components |
| Condition 14 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components |
| Condition 15 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components |
| Condition 16 | Experimental | Behavioral: community-friendly health recovery program, Drug: Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisStandard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- unable to provide consent
- actively suicidal
- actively homicidal
- actively psychotic
- display MoCA scores suggestive of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community-friendly health recovery programAlso: CHRPParticipants will receive 4 weekly 45 minute sessions HIV prevention sessions. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
| Pre-Exposure Prophylaxis and Post-Exposure ProphylaxisAlso: PrEPParticipants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention. | Drug | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
Primary outcome
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.
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.
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.
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.
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
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
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
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
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
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
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
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
10 secondary outcomes
HIV risk behaviors questionnaire
Time frame: HIV risk behaviors measured at Week 1
HIV risk behaviors questionnaire
Time frame: 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
HIV risk behaviors questionnaire
Time frame: 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
HIV prevention IMB model constructs questionnaire
Time frame: 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
HIV prevention IMB model constructs questionnaire
Time frame: 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
HIV prevention IMB model constructs questionnaire
Time frame: HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 37399447Mistler CB, Shrestha R, Gunstad J, Collins L, Madden L, Huedo-Medina T, Sibilio B, Copenhaver NM, Copenhaver M. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023 Jun 30;13(6):e071688. doi: 10.1136/bmjopen-2023-071688.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results will be available upon request.
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RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Copenhaver, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing community-friendly health recovery program and Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis in people with Hiv and Opioid Use Disorder, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Sibilio, BS (2037814690, brian.sibilio@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) (time frame: PrEP adherence DBS measured at week 4). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.