Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users (NCT01614106) | Clinical Trial Compass
CompletedNot Applicable
Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
United States360 participantsStarted 2013-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. be at least 18 years old
ā. be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV test in conjunction with confirmatory test or viral load)
ā. 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
ā. 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
ā. agree to have their blood drawn for CD4 and viral load testing
ā. report living in or near either Miami, Florida (FL), or Atlanta, Georgia (GA), and be able to return for follow-up visits
ā. provide locator information
ā. be able to communicate in English
Exclusion criteria
ā. do not meet any one or more of the above-described inclusion criteria
ā. are receiving patient navigator services for HIV care and/or substance abuse treatment