Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05108935
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* Participant in SSP
* History of self-report injection opioid use in the past 6 months
* Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months
* Not currently taking PrEP
* HIV negative
* Not pregnant
* Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV\* in the past 6 months
\*Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you?
* Traded sex for money or drugs
* Had a sexual partner who is HIV positive
* Did not consistently use condoms when having sex
* Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis)
* No medical contraindications for these medications such as history of renal failure or bone diseases
Exclusion Criteria:
* Have altered mental status in which participant cannot sign a consent form
* Receive a positive pregnancy test (will be checked at screening visit)
* Receive a positive HIV test at enrollment (will be checked at screening visit)
* Have evidence of renal failure (will be checked at screening visit)
* Have a history of hepatitis B (will be checked at screening visit)
* Becoming incarcerated during the study
Additional considerations:
The following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive:
* Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment
* Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05108935
Study Brief:
Protocol Section:
NCT05108935