Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
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Purpose
This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected crack cocaine 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/contacts during months 1-6 and 9 sessions of substance abuse treatment during months 1-3. 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 520 HIV-infected individuals who report crack cocaine use will be randomized, with approximately 260 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 |
- 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 crack cocaine users
- 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: | 520 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 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).
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|
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.
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Detailed Description:
This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected crack cocaine 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 |
Inclusion Criteria:
- 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)
- have a baseline viral load that is a detectable (>200 copies/mL) or unknown level in the past 3 months
- have a baseline CD4 count <350 cells/uL in the past 3 months
- report having used crack at least once/month for the past 6 months
- self-report that they have not been in HIV care for the past 6 months
- agree to have their blood drawn for CD4 and viral load testing
- report living in or near either Miami, FL, or Atlanta, 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 clinic
Exclusion Criteria:
- do not meet any one or more of the above-described inclusion criteria
- 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
Contacts and Locations| Contact: Paco Castellon, M.P.H. | 305-243-8419 | pc2594@columbia.edu |
| United States, Florida | |
| Jackson Health System-Special Immunology Clinic | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Paco Castellon, M.P.H. 305-243-8419 pc2594@columbia.edu | |
| Principal Investigator: Allan Rodriguez, M.D. | |
| United States, Georgia | |
| Grady Health System-Ponce De Leon Center | Not yet recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Christin Root 404-251-8893 cmroot@emory.edu | |
| Principal Investigator: Carlos del Rio, M.D. | |
| Principal Investigator: | Lisa R. Metsch, Ph.D. | Columbia University |
| Principal Investigator: | Carlos del Rio, M.D. | Emory University |
| Study Director: | Paco Castellon, M.P.H. | Columbia 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: | February 3, 2013 |
| 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:
|
Acquired Immunodeficiency Syndrome HIV Infections Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Mental Disorders Cocaine Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013