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

NCT01614106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-05-12

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Emory University

    collaborator OTHER
  • University of Miami

    collaborator OTHER
  • The Village South

    collaborator OTHER
  • Grady Health System

    collaborator OTHER
  • Jackson Health System

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Columbia University

    lead OTHER

Principal Investigators

  • Lisa R. Metsch, Ph.D. · Columbia University

  • Carlos del Rio, M.D. · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-12-31
Completion
2021-03-12

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614106 on ClinicalTrials.gov