Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

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.

Participants will be randomized to one of two groups: 1) "Retention Clinic" group and 2) Treatment as Usual. The intervention content of these groups is briefly described below:

Retention Clinic (RC) Group: This group will receive comprehensive and integrated services from a Retention Clinic. Services include HIV primary care, substance abuse treatment and mental health services, as needed. Participants in this group will also receive hands-on assistance with navigating through the clinic and accessing these services from a patient navigator.

Treatment as Usual (TAU) Group: This group will receive no protocol directed intervention. They will get the standard retention services from their local clinic.

All participants will provide informed consent and will complete a baseline audio computer-assisted self-interview or ACASI focusing on drug use, mental health, demographics and socio-economic factors, HIV care, and drug treatment history as well as blood draws for viral load and CD4 count. Follow-up assessments consisting of both ACASI and blood draws in all groups will be collected at 6 and 12 months post-randomization. Medical records will be reviewed to document use of HIV care, drug treatment and mental health services during the study period.

Inclusion criteria

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.

Exclusion criteria

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