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

NCT01614106 | Completed DMC

• 2 other identifiers: AAAK0606R01DA032098
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; AIDS; Substance Abuse

Keywords

HIV/AIDS; Drug Users; Crack-Cocaine Use; HIV Primary Care

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Attendance to HIV Care Visits

  12 months

• Adherence to HIV Treatment Regimens

  12 months

• Attendance to Substance Abuse Treatment

  12 months

• Decreasing Substance Use

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

Retention Clinic BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals will be excluded from study participation if they:
• 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

Sponsors & Collaborators

• Columbia University: lead
• Emory University: collaborator
• University of Miami: collaborator
• The Village South: collaborator
• Grady Health System: collaborator
• Jackson Health System: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Jackson Health System-Special Immunology Clinic

Miami, Florida, 33136, United States

Location

Grady Health System-Ponce De Leon Center

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

• Metsch LR, Feaster DJ, Gooden LK, Pan Y, Parish CL, Waldrop D, Rodriguez A, Colasanti JA, Armstrong WS, Root C, Del Rio C, Castellon PC, Miller M, Pereyra MR. Project RETAIN: Providing Integrated Care for People With HIV Who Use Cocaine. Open Forum Infect Dis. 2025 Mar 3;12(4):ofaf104. doi: 10.1093/ofid/ofaf104. eCollection 2025 Apr.

  PMID: 40276720 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders; Drug Misuse

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa R. Metsch, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

• Carlos del Rio, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stephen Smith Professor and Chair of Sociomedical Sciences Department

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: June 7, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 12, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

US (2)