Cognitive DysfunctionNCT05912374
Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
A study testing standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) and enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) in people with Cognitive Dysfunction, run by University of Connecticut at 1 site in United States.
Trial summary
The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) and enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years or older
- reported injection drug use in the past 30 days
- reported engagement in drug- and/or sex- related HIV risk behaviors
- HIV negative
- are willing to initiate PrEP use
- can communicate (read, write and speak) in English
- experience mild/moderate level of cognitive dysfunction
Who cannot join
- cannot attend all study sessions
- actively homicidal and/or suicidal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Cognitive Dysfunction Accommodation Strategies Into a Biobehavioral Pre-Exposure Prophylaxis (PrEP) Focused HIV Prevention Intervention for People Who Inject Drugs
The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence. Fifty people who inject drugs (PWID) were prescribed PrEP and randomized to one of two conditions, Twenty-five PWID participated in a standard HIV prevention session and 25 other PWID participated in a HIV prevention session with the included accommodation strategies. At recruitment participants were asked to provide self-report of the screening form and cognitive functioning. The intervention consisted of a total of 5 sessions: 1 meeting to gain baseline information of participants and 4 intervention sessions. Participants completed the consent form, demographics, skills assessment, drug use behavior assessment, and HIV risk behavior assessment at the pre-interview meeting. Participants completed PrEP uptake assessments and skills assessments immediately following the intervention to compare the pre/post results between the two groups. All participants also completed an acceptability rating to help researchers determine the acceptability of the accommodation strategies used, at the end of the 4th session. The objective was to determine if the proposed accommodation strategies are feasible and efficacious at improving HIV prevention outcomes, including knowledge and skills. Information gleaned from this process will be used to refine the intervention approach for future testing and implementation.
- Conditions
- Cognitive Dysfunction
- Being tested
- standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB), enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)Behavioural
CHRP-BB is an evidence-informed behavioral intervention for HIV prevention among high-risk drug users in treatment on PrEP. CHRP-BB consists of 4 weekly 50- minute sessions.
enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)Behavioural
The enhanced version of CHRP-BB is an adapted behavioral intervention for HIV prevention among high-risk drug users in treatment on PrEP. This intervention consists of 4 weekly 50- minute sessions that include cognitive dysfunction accommodation strategies.
| Study group | Role | What they receive |
|---|---|---|
| Control arm with standard intervention | Active comparator | Participants will complete a 4-week CHRP-BB standard intervention Receives: Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) |
| Experimental arm with enhanced intervention | Experimental | Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies. Receives: Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV risk reduction skills assessment at baseline
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
Measured: pre intervention (week 0)
HIV risk reduction skills assessment, post intervention
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
Measured: post intervention (week 4)
number of participants who picked up PrEP prescription
PrEP prescription filled by pharmacy
Measured: post intervention (week 4)
Secondary outcomes (3)
number of participants recruited
Feasibility was measured via recruitment success
Measured: pre intervention (week 0)
number of participants retained throughout study
Feasibility was measured via retention success
Measured: post intervention (week 4)
Intervention Acceptability
Participants completed an ten-item intervention acceptability rating, the lower the number the lower the participants acceptability of the intervention
Measured: post intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start7 Sep 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
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 Cognitive DysfunctionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled pilot trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
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 B Copenhaver, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912374
- Sponsor's protocol ID
- H22-0033
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mistler CB, Shrestha R, Copenhaver MM. Testing the feasibility, acceptability, and preliminary efficacy of integrating accommodation strategies into an HIV prevention intervention for people who inject drugs with cognitive dysfunction. J Subst Use Addict Treat. 2025 Feb;169:209582. doi: 10.1016/j.josat.2024.209582. Epub 2024 Nov 17.
PubMed 39551147
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Cognitive Dysfunction Accommodation Strategies Into a Biobehavioral Pre-Exposure Prophylaxis (PrEP) Focused HIV Prevention Intervention for People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT05912374
- Acronym / sponsor ID
- H22-0033
- Conditions
- Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 22 Jun 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 goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence. Fifty people who inject drugs (PWID) were prescribed PrEP and randomized to one of two conditions, Twenty-five PWID participated in a standard HIV prevention session and 25 other PWID participated in a HIV prevention session with the included accommodation strategies. At recruitment participants were asked to provide self-report of the screening form and cognitive functioning. The intervention consisted of a total of 5 sessions: 1 meeting to gain baseline information of participants and 4 intervention sessions. Participants completed the consent form, demographics, skills assessment, drug use behavior assessment, and HIV risk behavior assessment at the pre-interview meeting. Participants completed PrEP uptake assessments and skills assessments immediately following the intervention to compare the pre/post results between the two groups. All participants also completed an acceptability rating to help researchers determine the acceptability of the accommodation strategies used, at the end of the 4th session. The objective was to determine if the proposed accommodation strategies are feasible and efficacious at improving HIV prevention outcomes, including knowledge and skills. Information gleaned from this process will be used to refine the intervention approach for future testing and implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Control arm with standard intervention | Active comparator | Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)Participants will complete a 4-week CHRP-BB standard intervention |
| Experimental arm with enhanced intervention | Experimental | Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- at least 18 years or older
- reported injection drug use in the past 30 days
- reported engagement in drug- and/or sex- related HIV risk behaviors
- HIV negative
- are willing to initiate PrEP use
Key exclusion criteria (2 listed)
- cannot attend all study sessions
- actively homicidal and/or suicidal
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 |
|---|---|---|
| standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)CHRP-BB is an evidence-informed behavioral intervention for HIV prevention among high-risk drug users in treatment on PrEP. CHRP-BB consists of 4 weekly 50- minute sessions. | Behavioural | Control arm with standard intervention |
| enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)The enhanced version of CHRP-BB is an adapted behavioral intervention for HIV prevention among high-risk drug users in treatment on PrEP. This intervention consists of 4 weekly 50- minute sessions that include cognitive dysfunction accommodation strategies. | Behavioural | Experimental arm with enhanced intervention |
Primary outcome
HIV risk reduction skills assessment at baseline
Time frame: pre intervention (week 0)
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
HIV risk reduction skills assessment, post intervention
Time frame: post intervention (week 4)
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
number of participants who picked up PrEP prescription
Time frame: post intervention (week 4)
PrEP prescription filled by pharmacy
3 secondary outcomes
number of participants recruited
Time frame: pre intervention (week 0)
number of participants retained throughout study
Time frame: post intervention (week 4)
Intervention Acceptability
Time frame: post intervention (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 39551147Mistler CB, Shrestha R, Copenhaver MM. Testing the feasibility, acceptability, and preliminary efficacy of integrating accommodation strategies into an HIV prevention intervention for people who inject drugs with cognitive dysfunction. J Subst Use Addict Treat. 2025 Feb;169:209582. doi: 10.1016/j.josat.2024.209582. Epub 2024 Nov 17.
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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. This study is not recruiting at the moment.
Michael B 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 study testing standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) and enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) in people with Cognitive Dysfunction, 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jun 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV risk reduction skills assessment at baseline (time frame: pre intervention (week 0)). The study lists 3 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 NCT05912374, 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 22 Jun 2023.