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Table 1 Study eligibility criteria

From: Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)

Inclusion criteria

 Adults who meet all of the following criteria are eligible for inclusion in this study:

  1. At least 18 years of agea

  2. Urine test positive for recent opioid use and with evidence of recent injection drug use (“track marks”)

  3. Diagnosed with OUD per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5

  4. Able and willing to give informed consent

  5. Willing to start MOUD treatment

  6. Able to successfully complete an assessment of understanding

  7. For people who are not living with HIV: self-reported sharing injection equipment and/or condomless sex in the last 3 months with partners living with HIV or unknown statusb

  8. Able to provide adequate locator information

  9. Confirmed HIV status, as defined in the HPTN 094 SSP Manual

Exclusion criteria

 1. Received MOUD in the 30 days prior to enrollment by self-report

 2. Urine testing that is not negative for methadone within 30 days prior to enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.c

 3. Co-enrollment in any other interventional study unless approved by the Clinical Management Committee

  1. Persons who are otherwise eligible to be enrolled will have enrollment deferred if they are suspected to have COVID-19, until they meet the criteria for discontinuation of isolation per CDC guidelines or applicable local guidelines
  2. Prior to December 2021, the following criteria were as follows:
  3. a18 to 60 years of age
  4. bApplied to both people living with HIV or not living with HIV
  5. cApplied as of April 2023