Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 cocaine (including crack) 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.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614106
|United States, Florida|
|Jackson Health System-Special Immunology Clinic|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Grady Health System-Ponce De Leon Center|
|Atlanta, Georgia, United States, 30308|
|Principal Investigator:||Lisa R. Metsch, Ph.D.||Columbia University|
|Principal Investigator:||Carlos del Rio, M.D.||Emory University|