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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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).
Jackson Health System-Special Immunology Clinic
Miami, Florida, United States
Grady Health System-Ponce De Leon Center
Atlanta, Georgia, United States
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
Time frame: 12 months
Attendance to HIV Care Visits
To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at HIV care visits.
Time frame: 12 months
Adherence to HIV Treatment Regimens
To evaluate the effectiveness of the integrated care Retention Clinic in increasing adherence to HIV treatment regimens.
Time frame: 12 months
Attendance to Substance Abuse Treatment
To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at substance abuse treatment.
Time frame: 12 months
Decreasing Substance Use
To evaluate the effectiveness of the integrated care Retention Clinic in decreasing substance use.
Time frame: 12 months
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Enrollment
360