Recruiting PHASE4 Hiv

Prevention study for Hiv

Official title Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP

ClinicalTrials.gov ID: NCT05669534

What this study is testing

What is Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis?

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv.

Also referred to as PrEP.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • 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

You likely can't join if

  • unable to provide consent
  • actively suicidal
  • actively homicidal
  • actively psychotic
  • display MoCA scores suggestive of dementia
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • unable to provide consent
  • actively suicidal
  • actively homicidal
  • actively psychotic
  • display MoCA scores suggestive of dementia

The study team makes the final eligibility decision.

Where it's taking place

  • New Haven, Connecticut, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.