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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01612169
Eligibility Criteria:
Inclusion Criteria
Participating individuals must:
1. be admitted to a hospital and be HIV-infected at the time of recruitment
2. be at least 18 years old
3. meet one of the following: A) have an AIDS-defining illness during the current hospital admission; or B) have the most recent CD4 count and viral load performed within the past 6 months be \<350 cells/uL and \>200 copies/mL; or C) have the most recent CD4 count and viral load performed within the past 12 months be \<=500 cells/uL and \>200 copies/mL or unknown accompanied by the Site PI's discretion that the patient a) is likely to currently have a viral load \>200 copies/mL, b) is not currently successfully/correctly taking antiretroviral therapy (ART) and c) needs to be on ART
4. report (or have evidence in the medical record of) any opioid and/or stimulant and/or heavy alcohol use within the past 12 months (Note: Medical record evidence may consist of a) positive toxicology screen(s) for stimulants or heavy alcohol or b) clinician notes indicating heavy use of alcohol, use of stimulants or non-prescribed opioids or abuse of prescribed opioids.)
5. have a Karnofsky performance scale index score of \>=60
6. provide informed consent
7. provide locator information
8. sign a HIPAA form / medical record release form to facilitate medical record abstraction
9. report living in the vicinity and being able to return for follow-up visits
10. complete the baseline assessment, including blood draw
11. be able to communicate in English
Exclusion Criteria
Individuals will be excluded from the study if they:
1. do not meet any one or more of the above-described inclusion criteria
2. have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
3. are terminated via Site PI decision with agreement from study Lead Investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01612169
Study Brief:
Protocol Section:
NCT01612169