Study Summary
This trial will test a new approach to preventing HIV among people who inject drugs, which includes a medication (PrEP) and a behavioral program to help people stick to the medication.
Eligible Conditions
- HIV/AIDS
- Medication Adherence
- Risky Behaviors
- Substance Abuse
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Over a 9-month period
Over a 9-month period
HIV risk reduction behaviors
IMB measures related to PrEP adherence and HIV risk reduction
PrEP adherence
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Control Condition
1 of 2
CHRP-BB
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: CHRP-BB · No Placebo Group · N/A
CHRP-BB
Other
Experimental Group · 1 Intervention: CHRP-BB · Intervention Types: OtherControl ConditionNoIntervention Group · 1 Intervention: Control Condition · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over a 9-month period
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,305 Previous Clinical Trials
2,022,781 Total Patients Enrolled
APT Foundation, Inc.OTHER
5 Previous Clinical Trials
646 Total Patients Enrolled
University of ConnecticutLead Sponsor
167 Previous Clinical Trials
155,014 Total Patients Enrolled
Michael Copenhaver, PhDPrincipal Investigator - University of Connecticut
University of Connecticut
1 Previous Clinical Trials
256 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have engaged in risky behavior such as sharing needles or having unprotected sex within the last 3 months.
References
- Shrestha, Roman, Frederick Altice Altice, Pramila Karki, and Michael Copenhaver. 2017. “Developing an Integrated, Brief Biobehavioral HIV Prevention Intervention for High-risk Drug Users in Treatment: The Process and Outcome of Formative Research”. Frontiers in Immunology. Frontiers Media SA. doi:10.3389/fimmu.2017.00561.
- Huedo-Medina, Tania B., Roman Shrestha, and Michael Copenhaver. 2016. “Modeling a Theory-based Approach to Examine the Influence of Neurocognitive Impairment on HIV Risk Reduction Behaviors Among Drug Users in Treatment”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-016-1394-x.
- Fisher, Jeffrey D., and William A. Fisher. 1992. “Changing Aids-risk Behavior.”. Psychological Bulletin. American Psychological Association (APA). doi:10.1037/0033-2909.111.3.455.
- Shrestha, Roman, Pramila Karki, Frederick L. Altice, Tania B. Huedo-Medina, Jaimie P. Meyer, Lynn Madden, and Michael Copenhaver. 2017. “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 and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2016.12.023.
- Shrestha, Roman, Tania B. Huedo-Medina, Frederick L. Altice, Archana Krishnan, and Michael Copenhaver. 2016. “Examining the Acceptability of Mhealth Technology in HIV Prevention Among High-risk Drug Users in Treatment”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-016-1637-x.
- Copenhaver, Michael M., I-Ching Lee, and Patrick Baldwin. 2013. “A Randomized Controlled Trial of the Community-friendly Health Recovery Program (CHRP) Among High-risk Drug Users in Treatment”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-013-0539-4.
- Shrestha, Roman, Pramila Karki, Tania B. Huedo-Medina, and Michael Copenhaver. 2017. “Intent to Use Preexposure Prophylaxis (prep), HIV Risk Behaviors, and Self-report Neurocognitive Symptoms by High-risk Drug Users: A Mediation Analysis”. Journal of the Association of Nurses in AIDS Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jana.2017.04.005.
- Shrestha, Roman, Pramila Karki, Frederick L. Altice, Oleksandr Dubov, Liana Fraenkel, Tania Huedo-Medina, and Michael Copenhaver. 2017. “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 and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-017-1851-1.
- Copenhaver, Michael M., I.-Ching Lee, and Arthur Margolin. 2007. “Successfully Integrating an HIV Risk Reduction Intervention into a Community-based Substance Abuse Treatment Program”. The American Journal of Drug and Alcohol Abuse. Informa UK Limited. doi:10.1080/00952990601087463.
- Avants, S.Kelly, Arthur Margolin, Mary Helen Usubiaga, and Cheryl Doebrick. 2004. “Targeting Hiv-related Outcomes with Intravenous Drug Users Maintained on Methadone: A Randomized Clinical Trial of a Harm Reduction Group Therapy”. Journal of Substance Abuse Treatment. Elsevier BV. doi:10.1016/s0740-5472(03)00159-4.
- Shrestha, Roman, Frederick L. Altice, Tania B. Huedo-Medina, Pramila Karki, and Michael Copenhaver. 2016. “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 and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-016-1650-0.
- Fisher, Jeffrey D., and William A. Fisher. 1992. “Changing Aids-risk Behavior.”. Psychological Bulletin. American Psychological Association (APA). doi:10.1037/0033-2909.111.3.455.
- Copenhaver 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.
- Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
- Avants 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.
- Shrestha 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.
- Michael Copenhaver 2017. "Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03282890.
Frequently Asked Questions
Are there any vacancies for volunteers in this medical experiment?
"As per clinicaltrials.gov, this trial is actively recruiting participants since it was initially posted on September 1st 2017 and recently modified on June 7th 2022." - Anonymous Online Contributor
Unverified Answer
How many individuals can partake in this investigation at any one time?
"Affirmative. According to clinicaltrials.gov, the recruitment for this research project, which was posted on September 1st 2017 and most recently updated on June 7th 2022, is still ongoing. The study has a capacity of 300 participants across one site." - Anonymous Online Contributor
Unverified Answer