Back to resultsProject RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
Primary Purpose
HIV, AIDS, Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retention Clinic
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV/AIDS, Drug Users, Crack-Cocaine Use, HIV Primary Care
Eligibility Criteria
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
Sites / Locations
- Jackson Health System-Special Immunology Clinic
- Grady Health System-Ponce De Leon Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Treatment as Usual (TAU)
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Virologic suppression
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
To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at HIV care visits.
Adherence to HIV Treatment Regimens
To evaluate the effectiveness of the integrated care Retention Clinic in increasing adherence to HIV treatment regimens.
Attendance to Substance Abuse Treatment
To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at substance abuse treatment.
Decreasing Substance Use
To evaluate the effectiveness of the integrated care Retention Clinic in decreasing substance use.
Full Information
NCT ID
NCT01614106
First Posted
March 14, 2012
Last Updated
May 11, 2022
Sponsor
Columbia University
Collaborators
Emory University, University of Miami, The Village South, Grady Health System, Jackson Health System, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01614106
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Emory University, University of Miami, The Village South, Grady Health System, Jackson Health System, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, Substance Abuse
Keywords
HIV/AIDS, Drug Users, Crack-Cocaine Use, HIV Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Retention Clinic
Intervention Description
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).
Primary Outcome Measure Information:
Title
Virologic suppression
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Attendance to HIV Care Visits
Description
To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at HIV care visits.
Time Frame
12 months
Title
Adherence to HIV Treatment Regimens
Description
To evaluate the effectiveness of the integrated care Retention Clinic in increasing adherence to HIV treatment regimens.
Time Frame
12 months
Title
Attendance to Substance Abuse Treatment
Description
To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at substance abuse treatment.
Time Frame
12 months
Title
Decreasing Substance Use
Description
To evaluate the effectiveness of the integrated care Retention Clinic in decreasing substance use.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa R. Metsch, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos del Rio, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Health System-Special Immunology Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Grady Health System-Ponce De Leon Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
We'll reach out to this number within 24 hrs