Risk BehaviorCHRP-BBNCT03282890
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
A study testing CHRP-BB in people with Risk Behavior and HIV/AIDS, run by University of Connecticut at 1 site in United States.
Trial summary
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk Behavior, HIV/AIDS, Medication Adherence
- What is being tested?
- CHRP-BB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Meet DSM-V criteria for opioid-dependence and are enrolled in methadone maintenance drug treatment at the APT Foundation, Inc.
- Were confirmed to be HIV-negative and started on PrEP in the past week
- Report unsafe injection drug use practices or unprotected sex within the past 3 months
- Have a cell phone
- Are able to read and understand the questionnaires, ACASI, and informed consent form
- Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., pending charges, jail term).
Who cannot join
- Have an untreated bipolar or psychotic disorder
- Are actively suicidal or homicidal as assessed by trained research staff under the supervision of a licensed clinical psychologist
- Cannot speak English
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD.
Read the detailed description
PWUD remain a priority population as they represent a critical conduit for new HIV infections, which are transmitted through preventable drug- and sex-related HIV risk behaviors. Pre-Exposure Prophylaxis (PrEP) - the daily self-administration of antiretroviral medication - has enormous potential to bolster primary HIV prevention outcomes among PWUD. PrEP is a FDA-approved biomedical HIV prevention strategy recommended by the CDC and WHO for key populations, including PWUD. Despite unequivocal evidence supporting PrEP, its scale-up has been nearly absent among high risk PWUD. Moreover, adherence to PrEP is crucial if it is to be effective with high risk individuals. Recent research, however, indicates that optimal PrEP adherence may be compromised by neurocognitive impairment (NCI), particularly among PWUD. Due to chronic drug use, related lifestyle experiences, and other health challenges, many PWUD experience NCI to the extent that it impedes medication adherence, HIV risk reduction, and treatment retention. In a recent HIV prevention trial, over a third of high risk PWUD on opioid replacement therapy (ORT) had moderate to high levels of NCI and, moreover, were less likely to reduce their HIV transmission risk vs. those without NCI. The potentially disruptive impact of NCI must therefore be addressed when designing contemporary intervention strategies targeting PWUD. Contemporary approaches must also be cost-effective and usable in real-world treatment settings, such as methadone maintenance programs (MMPs) where high risk PWUD are concentrated and can be readily reached with primary prevention. To date, however, primary prevention efforts have largely relied on singular strategies (e.g., methadone or PrEP alone) with modest HIV risk reduction outcomes for PWUD. Instead, advancing combination approaches capable of harnessing the synergy and efficiency possible via multiple evidence-based strategies is most effective. This combination strategy is especially important when intervening with high risk PWUD with NCI due to the potential decreased effectiveness of PrEP when adherence is suboptimal, thereby necessitating behavioral interventions that focus on reducing HIV risk and increasing PrEP adherence. Building on promising preliminary work, the proposed trial will fill a critical void by testing an integrated bio-behavioral approach that incorporates the use of PrEP with an evidence-based behavioral approach and, using innovative strategies, enhances PrEP adherence and HIV risk behavior in a manner that accommodates NCI among PWUD.
- Conditions
- Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse
- Being tested
- CHRP-BB
- Keywords
- HIV, Substance Abuse, Pre-Exposure Prophylaxis, HIV Risk Behavior, Methadone Maintenance
- Medical subject headings
- Risk-Taking, Acquired Immunodeficiency Syndrome, Medication Adherence, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHRP-BBOther
The CHRP-BB intervention is a theory-based, manual-guided, HIV risk reduction and PrEP adherence intervention. It is an integrated evidence-based intervention that uses a coping skills training approach to primary prevention and is delivered in a small group modality by two trained intervention facilitators using a motivational enhancement therapeutic style to address high risk drug- and sex-related HIV risk behaviors and PrEP adherence. Importantly, the CHRP-BB intervention includes specific behavioral and mHealth strategies designed and tested to accommodate difficulties stemming from moderate to severe neuro-cognitive impairment (NCI).
| Study group | Role | What they receive |
|---|---|---|
| CHRP-BB | Experimental | Patients assigned to the CHRP-BB will receive a weekly HIV risk reduction and PrEP adherence group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. It is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP-BB, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction and PrEP adherence. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). Receives: Other: CHRP-BB |
| Control Condition | No intervention | The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-exposure Prophylaxis (PrEP) Adherence Behavior
The Pre-exposure prophylaxis (PrEP) adherence behavior scale is an 11-item categorical self-report measure designed to assess how confident a participant is about properly taking their PrEP medication (e.g., "How confident are you that you could make PrEP part of your daily routine?"). The scale requires participants to respond to each of the 11 items about adherence by selecting whether they are either 'Not at all confident', 'Somewhat confident', 'Moderately confident', 'Very confident', or 'Completely confident' about the behavior. The 11 items are summed to create a total score, with higher scores indicating a better PrEP adherence behavior outcome. The possible range of total scores is 0-44.
Measured: This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.
Secondary outcomes (1)
HIV Risk Reduction Behavior
HIV risk reduction behavior was assessed using a 4-item categorical self-report measure designed to assess the participant's self-efficacy about engaging in behaviors to reduce their HIV risk (e.g., 'How hard would it be for you to always use condoms or latex protection if you have oral, vaginal, or anal sex?"). The measure requires participants to select one of five possible responses for each of the four items, indicating whether a behavior would be either 'Very hard to do', 'Fairly hard to do', 'Neither hard nor easy to do', 'Somewhat easy to do', or 'Very easy to do'. Responses to the four items were summed and reversed to create a total score, with higher scores indicating a better HIV risk reduction outcome.The possible range of total HIV risk reduction behavior scores is 4 to 20.
Measured: This was assessed immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start20 Nov 2017
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Risk BehaviorStudies 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
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), APT Foundation, Inc.
- 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
- NCT03282890
- Sponsor's protocol ID
- H17-200
- Other IDs
- R01DA044867
- Acronym
- CHRP-BB
- Status last verified
- Jul 2025
- First submitted
- 12 Sep 2017
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shrestha R, Altice F, Karki P, Copenhaver M. Developing an Integrated, Brief Biobehavioral HIV Prevention Intervention for High-Risk Drug Users in Treatment: The Process and Outcome of Formative Research. Front Immunol. 2017 May 11;8:561. doi: 10.3389/fimmu.2017.00561. eCollection 2017.
PubMed 28553295Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2.
PubMed 28214391Huedo-Medina TB, Shrestha R, Copenhaver M. Modeling a Theory-Based Approach to Examine the Influence of Neurocognitive Impairment on HIV Risk Reduction Behaviors Among Drug Users in Treatment. AIDS Behav. 2016 Aug;20(8):1646-57. doi: 10.1007/s10461-016-1394-x.
PubMed 27052845Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
PubMed 1594721Shrestha R, Huedo-Medina TB, Altice FL, Krishnan A, Copenhaver M. Examining the Acceptability of mHealth Technology in HIV Prevention Among High-Risk Drug Users in Treatment. AIDS Behav. 2017 Nov;21(11):3100-3110. doi: 10.1007/s10461-016-1637-x.
PubMed 28025735Copenhaver MM, Lee IC, Margolin A. Successfully integrating an HIV risk reduction intervention into a community-based substance abuse treatment program. Am J Drug Alcohol Abuse. 2007;33(1):109-20. doi: 10.1080/00952990601087463.
PubMed 17366251Copenhaver MM, Lee IC, Baldwin P. A randomized controlled trial of the community-friendly health recovery program (CHRP) among high-risk drug users in treatment. AIDS Behav. 2013 Nov;17(9):2902-13. doi: 10.1007/s10461-013-0539-4.
PubMed 23835735Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4.
PubMed 15050083Shrestha R, Karki P, Altice FL, Dubov O, Fraenkel L, Huedo-Medina T, Copenhaver M. Measuring Acceptability and Preferences for Implementation of Pre-Exposure Prophylaxis (PrEP) Using Conjoint Analysis: An Application to Primary HIV Prevention Among High Risk Drug Users. AIDS Behav. 2018 Apr;22(4):1228-1238. doi: 10.1007/s10461-017-1851-1.
PubMed 28695388Shrestha R, Karki P, Huedo-Medina TB, Copenhaver M. Intent to Use Preexposure Prophylaxis (PrEP), HIV Risk Behaviors, and Self-Report Neurocognitive Symptoms by High-Risk Drug Users: A Mediation Analysis. J Assoc Nurses AIDS Care. 2017 Jul-Aug;28(4):612-621. doi: 10.1016/j.jana.2017.04.005. Epub 2017 Apr 19.
PubMed 28478870Shrestha R, Altice FL, Huedo-Medina TB, Karki P, Copenhaver M. Willingness to Use Pre-Exposure Prophylaxis (PrEP): An Empirical Test of the Information-Motivation-Behavioral Skills (IMB) Model among High-Risk Drug Users in Treatment. AIDS Behav. 2017 May;21(5):1299-1308. doi: 10.1007/s10461-016-1650-0.
PubMed 27990587
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
- ClinicalTrials.gov ID
- NCT03282890
- Acronym / sponsor ID
- CHRP-BB / H17-200
- Conditions
- Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse
- Keywords
- HIV, Substance Abuse, Pre-Exposure Prophylaxis, HIV Risk Behavior, Methadone Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), APT Foundation, Inc.
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD.
Detailed description
PWUD remain a priority population as they represent a critical conduit for new HIV infections, which are transmitted through preventable drug- and sex-related HIV risk behaviors. Pre-Exposure Prophylaxis (PrEP) - the daily self-administration of antiretroviral medication - has enormous potential to bolster primary HIV prevention outcomes among PWUD. PrEP is a FDA-approved biomedical HIV prevention strategy recommended by the CDC and WHO for key populations, including PWUD. Despite unequivocal evidence supporting PrEP, its scale-up has been nearly absent among high risk PWUD. Moreover, adherence to PrEP is crucial if it is to be effective with high risk individuals. Recent research, however, indicates that optimal PrEP adherence may be compromised by neurocognitive impairment (NCI), particularly among PWUD. Due to chronic drug use, related lifestyle experiences, and other health challenges, many PWUD experience NCI to the extent that it impedes medication adherence, HIV risk reduction, and treatment retention. In a recent HIV prevention trial, over a third of high risk PWUD on opioid replacement therapy (ORT) had moderate to high levels of NCI and, moreover, were less likely to reduce their HIV transmission risk vs. those without NCI. The potentially disruptive impact of NCI must therefore be addressed when designing contemporary intervention strategies targeting PWUD. Contemporary approaches must also be cost-effective and usable in real-world treatment settings, such as methadone maintenance programs (MMPs) where high risk PWUD are concentrated and can be readily reached with primary prevention. To date, however, primary prevention efforts have largely relied on singular strategies (e.g., methadone or PrEP alone) with modest HIV risk reduction outcomes for PWUD. Instead, advancing combination approaches capable of harnessing the synergy and efficiency possible via multiple evidence-based strategies is most effective. This combination strategy is especially important when intervening with high risk PWUD with NCI due to the potential decreased effectiveness of PrEP when adherence is suboptimal, thereby necessitating behavioral interventions that focus on reducing HIV risk and increasing PrEP adherence. Building on promising preliminary work, the proposed trial will fill a critical void by testing an integrated bio-behavioral approach that incorporates the use of PrEP with an evidence-based behavioral approach and, using innovative strategies, enhances PrEP adherence and HIV risk behavior in a manner that accommodates NCI among PWUD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHRP-BB | Experimental | Other: CHRP-BBPatients assigned to the CHRP-BB will receive a weekly HIV risk reduction and PrEP adherence group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. It is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP-BB, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction and PrEP adherence. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). |
| Control Condition | No intervention | –The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet DSM-V criteria for opioid-dependence and are enrolled in methadone maintenance drug treatment at the APT Foundation, Inc.
- Were confirmed to be HIV-negative and started on PrEP in the past week
- Report unsafe injection drug use practices or unprotected sex within the past 3 months
- Have a cell phone
- Are able to read and understand the questionnaires, ACASI, and informed consent form
Key exclusion criteria (3 listed)
- Have an untreated bipolar or psychotic disorder
- Are actively suicidal or homicidal as assessed by trained research staff under the supervision of a licensed clinical psychologist
- Cannot speak English
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 |
|---|---|---|
| CHRP-BBThe CHRP-BB intervention is a theory-based, manual-guided, HIV risk reduction and PrEP adherence intervention. It is an integrated evidence-based intervention that uses a coping skills training approach to primary prevention and is delivered in a small group modality by two trained intervention facilitators using a motivational enhancement therapeutic style to address high risk drug- and sex-related HIV risk behaviors and PrEP adherence. Importantly, the CHRP-BB intervention includes specific behavioral and mHealth strategies designed and tested to accommodate difficulties stemming from moderate to severe neuro-cognitive impairment (NCI). | Other | CHRP-BB |
Primary outcome
Pre-exposure Prophylaxis (PrEP) Adherence Behavior
Time frame: This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.
The Pre-exposure prophylaxis (PrEP) adherence behavior scale is an 11-item categorical self-report measure designed to assess how confident a participant is about properly taking their PrEP medication (e.g., "How confident are you that you could make PrEP part of your daily routine?"). The scale requires participants to respond to each of the 11 items about adherence by selecting whether they are either 'Not at all confident', 'Somewhat confident', 'Moderately confident', 'Very confident', or 'Completely confident' about the behavior. The 11 items are summed to create a total score, with higher scores indicating a better PrEP adherence behavior outcome. The possible range of total scores is 0-44.
1 secondary outcome
HIV Risk Reduction Behavior
Time frame: This was assessed immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28553295Shrestha R, Altice F, Karki P, Copenhaver M. Developing an Integrated, Brief Biobehavioral HIV Prevention Intervention for High-Risk Drug Users in Treatment: The Process and Outcome of Formative Research. Front Immunol. 2017 May 11;8:561. doi: 10.3389/fimmu.2017.00561. eCollection 2017.
- Background: PubMed 28214391Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2.
- Background: PubMed 27052845Huedo-Medina TB, Shrestha R, Copenhaver M. Modeling a Theory-Based Approach to Examine the Influence of Neurocognitive Impairment on HIV Risk Reduction Behaviors Among Drug Users in Treatment. AIDS Behav. 2016 Aug;20(8):1646-57. doi: 10.1007/s10461-016-1394-x.
- Background: PubMed 1594721Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
- Background: PubMed 28025735Shrestha R, Huedo-Medina TB, Altice FL, Krishnan A, Copenhaver M. Examining the Acceptability of mHealth Technology in HIV Prevention Among High-Risk Drug Users in Treatment. AIDS Behav. 2017 Nov;21(11):3100-3110. doi: 10.1007/s10461-016-1637-x.
- Background: PubMed 17366251Copenhaver MM, Lee IC, Margolin A. Successfully integrating an HIV risk reduction intervention into a community-based substance abuse treatment program. Am J Drug Alcohol Abuse. 2007;33(1):109-20. doi: 10.1080/00952990601087463.
- Background: PubMed 23835735Copenhaver MM, Lee IC, Baldwin P. A randomized controlled trial of the community-friendly health recovery program (CHRP) among high-risk drug users in treatment. AIDS Behav. 2013 Nov;17(9):2902-13. doi: 10.1007/s10461-013-0539-4.
- Background: PubMed 15050083Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4.
- Background: PubMed 28695388Shrestha R, Karki P, Altice FL, Dubov O, Fraenkel L, Huedo-Medina T, Copenhaver M. Measuring Acceptability and Preferences for Implementation of Pre-Exposure Prophylaxis (PrEP) Using Conjoint Analysis: An Application to Primary HIV Prevention Among High Risk Drug Users. AIDS Behav. 2018 Apr;22(4):1228-1238. doi: 10.1007/s10461-017-1851-1.
- Background: PubMed 28478870Shrestha R, Karki P, Huedo-Medina TB, Copenhaver M. Intent to Use Preexposure Prophylaxis (PrEP), HIV Risk Behaviors, and Self-Report Neurocognitive Symptoms by High-Risk Drug Users: A Mediation Analysis. J Assoc Nurses AIDS Care. 2017 Jul-Aug;28(4):612-621. doi: 10.1016/j.jana.2017.04.005. Epub 2017 Apr 19.
- Background: PubMed 27990587Shrestha R, Altice FL, Huedo-Medina TB, Karki P, Copenhaver M. Willingness to Use Pre-Exposure Prophylaxis (PrEP): An Empirical Test of the Information-Motivation-Behavioral Skills (IMB) Model among High-Risk Drug Users in Treatment. AIDS Behav. 2017 May;21(5):1299-1308. doi: 10.1007/s10461-016-1650-0.
- University of Connecticut Institute for Collaboration on Health, Intervention, and Policy (InCHIP)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 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 CHRP-BB in people with Risk Behavior and HIV/AIDS, 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 6 inclusion and 3 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 17 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-exposure Prophylaxis (PrEP) Adherence Behavior (time frame: This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.). 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 NCT03282890, which also lists 11 linked publications.
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 17 Aug 2025.