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:

1. be at least 18 years old

2. be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV
test in conjunction with confirmatory test or viral load)

3. 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

4. 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

5. agree to have their blood drawn for CD4 and viral load testing

6. report living in or near either Miami, FL, or Atlanta, GA, and be able to return for
follow-up visits

7. provide locator information

8. be able to communicate in English

9. provide written informed consent

10. sign a HIPAA Authorization form/medical record release to facilitate medical record
abstraction

11. 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:

1. do not meet any one or more of the above-described inclusion criteria

2. are receiving patient navigator services for HIV care and/or substance abuse treatment

3. have significant cognitive or developmental impairment to the extent that they are
unable to provide informed consent

4. are terminated via site PI decision