An interventional study of CHRP-BB in Risk Behavior, HIV/AIDS and Medication Adherence, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention
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.
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.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's enrollment of 237 is close to the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →University of Connecticut is the lead sponsor of 135 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: CHRP-BB
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).
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).
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.
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.
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.
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.
| Milestone | CHRP-BB (Experimental Condition) | Active Control Condition |
|---|---|---|
| Started | 120 | 117 |
| Post-test | 105 | 104 |
| 3-month follow-up | 102 | 101 |
| 6-month follooup | 74 | 75 |
| 9-month follow-up | 68 | 64 |
| Completed | 68 | 64 |
| Not completed | 52 | 53 |
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.
| score | CHRP-BB (Experimental Condition) | Active Control Condition |
|---|---|---|
| Pre-exposure Prophylaxis (PrEP) Adherence Behavior | 25.9 (20.4 to 31.3) | 22.8 (18.9 to 26.7) |
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.
| score | CHRP-BB (Experimental Condition) | Active Control Condition |
|---|---|---|
| HIV Risk Reduction Behavior | 17.5 (16.8 to 18.1) | 16.2 (15.3 to 17.0) |
Collected over Adverse event data were collected from each participant at baseline, immediately following the 8-week intervention period, and then 3m, 6m, and 9-months post intervention. The adverse event time frame was 11/20/2017 - 10/13/2023.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHRP-BB | 0/120 (0%) | 0/120 (0%) | 0/120 (0%) |
| Control Condition | 0/117 (0%) | 0/117 (0%) | 0/117 (0%) |
| Age, Categorical(Participants) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 120 | 117 | 237 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| Median | 44 (19 to 64) | 44 (19 to 64) | 44 (19 to 64) |
| Sex: Female, Male(Participants) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| Gender — Female | 58 | 56 | 114 |
| Gender — Male | 62 | 61 | 123 |
| Ethnicity (NIH/OMB)(Participants) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 13 | 36 |
| Not Hispanic or Latino | 96 | 97 | 193 |
| Unknown or Not Reported | 1 | 7 | 8 |
| Race (NIH/OMB)(Participants) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 20 | 29 | 49 |
| White | 76 | 68 | 144 |
| More than one race | 23 | 13 | 36 |
| Unknown or Not Reported | 1 | 7 | 8 |
| Region of Enrollment(participants) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| United States | 120 | 117 | 237 |
| Currently unemployed(Participants) | CHRP-BB | Active Control Condition | Total |
|---|---|---|---|
| Number | 47 | 42 | 89 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Oct 2023, 70 months.
Results were first posted in Aug 2025, 1 year 10 months after primary completion.
Of 65 non-industry interventional studies with no phase under Risk-Taking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's 70 months is above that.
Counting every sponsor, half of 68 studies reached it within 28 months; a quarter within 7 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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