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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Columbia University
Sponsor:
Collaborators:
Emory University
University of Miami
The Village South, Inc.
South Florida AIDS Network
Grady Health System
Jackson Health System
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT01614106
First received: March 14, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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. Eligible participants will be randomized to one of the following two groups: 1) "Retention Clinic" or 2) Treatment as Usual. The intervention ("Retention Clinic") group will receive up to 11 Patient Navigator sessions over a 6 month period and 9 sessions of substance abuse treatment over a 3 month period. Follow-up assessments will be conducted 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. A total of 360 HIV-infected individuals who report cocaine (including crack) use will be randomized, with approximately 180 from each site (Miami, FL, and Atlanta, GA). 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.


Condition Intervention
HIV
AIDS
Substance Abuse
Behavioral: Retention Clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Virologic suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the integrated "Retention Clinic" in achieving virologic suppression (defined as having an HIV-1 viral load <200 copies/mL at 6 and 12 months) among HIV-infected cocaine (including crack) users


Secondary Outcome Measures:
  • Attendance to HIV Care Visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at HIV care visits.

  • Adherence to HIV Treatment Regimens [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the integrated care Retention Clinic in increasing adherence to HIV treatment regimens.

  • Attendance to Substance Abuse Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at substance abuse treatment.

  • Decreasing Substance Use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the integrated care Retention Clinic in decreasing substance use.


Estimated Enrollment: 360
Study Start Date: January 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The Retention Clinic will incorporate HIV primary care and mental health services with on-site substance abuse treatment and patient navigation. The central components will include: Primary HIV Care; Mental Health Services; Skill-building; and On-Site substance abuse treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).
Behavioral: Retention Clinic
The central components of the Retention Clinic will include: Primary HIV Care; Patient Navigator services (including Informational support, Educational information, Motivational/Emotional support, Skill Building activities); Mental Health Services; and On-Site Substance Abuse Treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).
No Intervention: Treatment as Usual (TAU)
The treatment as usual (TAU) group condition will represent standard of care at both of the participating clinics. Standard of care at both clinics includes primary HIV care, the provision of mental health services, and the assignment of a clinic case manager. These case managers meet with patients when they first come to clinic and then meet with them as needed and typically offer substance-using patients a referral to substance abuse treatment in the community as needed. Case managers usually do not follow up to determine the uptake of these referrals.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614106

Contacts
Contact: Paco Castellon, M.P.H. 786-703-9814 pc2594@columbia.edu

Locations
United States, Florida
Jackson Health System-Special Immunology Clinic Recruiting
Miami, Florida, United States, 33136
Contact: Terri Liguori, M.Ed, Ed.S.    786-703-9817    tl2547@columbia.edu   
Principal Investigator: Allan Rodriguez, M.D.         
United States, Georgia
Grady Health System-Ponce De Leon Center Recruiting
Atlanta, Georgia, United States, 30308
Contact: Christin Root    404-251-8893    cmroot@emory.edu   
Principal Investigator: Carlos del Rio, M.D.         
Sponsors and Collaborators
Columbia University
Emory University
University of Miami
The Village South, Inc.
South Florida AIDS Network
Grady Health System
Jackson Health System
Investigators
Principal Investigator: Lisa R. Metsch, Ph.D. Columbia University
Principal Investigator: Carlos del Rio, M.D. Emory University
  More Information

No publications provided

Responsible Party: Lisa Metsch, Stephen Smith Professor and Chair of Sociomedical Sciences Department, Columbia University
ClinicalTrials.gov Identifier: NCT01614106     History of Changes
Other Study ID Numbers: AAAK0606, R01DA032098
Study First Received: March 14, 2012
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Columbia University:
HIV/AIDS
Drug Users
Crack-Cocaine Use
HIV Primary Care

Additional relevant MeSH terms:
Cocaine
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 20, 2014