NCT05669534 · University of Connecticut
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
(MOST)
What this study is about
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).
View original scientific description
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).
Interventions
BEHAVIORAL
community-friendly health recovery program
Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
DRUG
Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Primary outcome measures
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Time frame: PrEP adherence DBS measured at week 4
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Time frame: PrEP adherence DBS measured at the 3-month post-intervention follow-up
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Time frame: PrEP adherence DBS measured at the 6-month post-intervention follow-up
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Time frame: PrEP adherence DBS measured at the 9-month post-intervention follow-up
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Time frame: PrEP adherence pharmacy refill data measured at week 4
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Time frame: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Time frame: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via pharmacy refill data
Time frame: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up
Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via self-report scale
Time frame: PrEP adherence pharmacy self report measured at week 4
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Pre-Exposure Prophylaxis Adherence via self-report scale
Time frame: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Pre-Exposure Prophylaxis Adherence via self-report scale
Time frame: PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Pre-Exposure Prophylaxis Adherence via self-report scale
Time frame: PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups
Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations