Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
Completed · Not applicable
Conditions studied: HIV, AIDS, Substance Abuse
In brief
This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected cocaine (including crack) users by using a two-group randomized, prospective trial. A total of 360 HIV-infected individuals who report cocaine (including crack) use will be randomized across study sites. The primary hypothesis is that more participants randomized to the "Retention Clinic" will have undetectable viral load than will participants randomized to the treatment as usual group.
Key facts
- Study ID
- NCT01614106
- Run by
- Columbia University
- People needed
- 360
- Starts
- 2013-01-01
- Expected to finish
- 2021-03-12
- Last updated by the study team
- 2022-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participating individuals must:
- be at least 18 years old
- be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV test in conjunction with confirmatory test or viral load)
- meet one of the following: a) have an (*)AIDS-defining illness OR b) have a CD4 count <350 cells/uL AND a viral load >1000 copies/mL in the medical record in the past 3 months OR c) have a CD4 count <350 cells/uL AND a viral load >200 copies/mL as obtained via baseline blood draw OR d) have a clinical profile indicative of a persistently detectable HIV viral load (>200 copies/mL) attributed to non-adherence to HIV medications as per PI evaluation of the individual and/or individual's medical record
- report (OR have evidence in the medical record of) any cocaine (including crack) use in the past 3 months OR (**)have a positive toxicology result for cocaine via the study toxicology screen
- agree to have their blood drawn for CD4 and viral load testing
- report living in or near either Miami, Florida (FL), or Atlanta, Georgia (GA), and be able to return for follow-up visits
- provide locator information
- be able to communicate in English
- provide written informed consent
- sign a HIPAA Authorization form/medical record release to facilitate medical record abstraction
- be willing to go to the study clinic
- (*)Site PI discretion will be used to assess whether or not the AIDS-defining illness is a good indicator of eligibility. For example, if a patient does not meet the CD4 and viral load criteria and does have an AIDS-defining illness, the Site PI will assess the AIDS-defining illness to determine whether or not the patient is a suitable candidate for the study.
- (**)Per PI discretion, the urine toxicology screen may be administered as part of the screening process if the participant's self-report and/or medical record data renders him/her ineligible on the drug use criterion.
You may not qualify if…
- Individuals will be excluded from study participation if they:
- do not meet any one or more of the above-described inclusion criteria
- are receiving patient navigator services for HIV care and/or substance abuse treatment
- have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
- are terminated via site PI decision
Where it is running
- Jackson Health System-Special Immunology Clinic — Miami, Florida, United States
- Grady Health System-Ponce De Leon Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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