NCT05669534 Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
| NCT ID | NCT05669534 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Connecticut |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 256 participants in total. It began in 2023-03-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * unable to provide consent * actively suicidal * actively homicidal * actively psychotic * display MoCA scores suggestive of dementia
Contact & Investigator
Michael Copenhaver, PhD
PRINCIPAL INVESTIGATOR
University of Connecticut
Frequently Asked Questions
Who can join the NCT05669534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05669534 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05669534 currently recruiting?
Yes, NCT05669534 is actively recruiting participants. Contact the research team at brian.sibilio@uconn.edu for enrollment information.
Where is the NCT05669534 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05669534 clinical trial?
NCT05669534 is sponsored by University of Connecticut. The principal investigator is Michael Copenhaver, PhD at University of Connecticut. The trial plans to enroll 256 participants.
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