Clinical trial NCT01614106: Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
Official title: Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Substance Abuse
Keywords: HIV/AIDS
Drug Users
Crack-Cocaine Use
HIV Primary Care
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of Miami
name: The Village South
name: Grady Health System
name: Jackson Health System
name: National Institute on Drug Abuse (NIDA)
First posted: 2012-06-07
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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, Florida (FL), or Atlanta, Georgia (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

Primary outcomes:
measure: Virologic suppression
timeFrame: 12 months
Secondary outcomes:
measure: Attendance to HIV Care Visits
timeFrame: 12 months
measure: Adherence to HIV Treatment Regimens
timeFrame: 12 months
measure: Attendance to Substance Abuse Treatment
timeFrame: 12 months
measure: Decreasing Substance Use
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Health System-Special Immunology Clinic
state: Florida
city: Atlanta
country: United States
facility: Grady Health System-Ponce De Leon Center
state: Georgia
Study officials:
affiliation: Columbia University
name: Lisa R. Metsch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Carlos del Rio, M.D.
role: PRINCIPAL_INVESTIGATOR
References: