Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users

Summary

Primary Objective: This study will evaluate the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU).

Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of \<= 200 copies/mL) relative to non-suppression or all-cause mortality in the 3 study groups will differ from each other at the 12 month follow-up.

Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of \<= 200 copies/mL) in the PN+CM group will be greater than that in the TAU group.

Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than that in the PN group.

Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that in the TAU group.

Secondary Objectives:

1. To evaluate the effect of the experimental interventions on: HIV virological suppression and CD4 T-cell count changes at 6 months post-randomization; engagement in HIV primary care and visit attendance; and rate of hospitalizations.
2. To evaluate the effect of the experimental interventions on: drug use frequency and severity; and drug use treatment engagement and session attendance.
3. To assess selected mechanisms of action of the intervention (.i.e. mediators of intervention effect).
4. To assess potential characteristics associated with differential treatment effectiveness (i.e. moderators of intervention effect).
5. To evaluate the incremental cost and cost-effectiveness of the interventions.

Conditions

• HIV
• AIDS
• Substance Abuse
• Inpatient

Interventions

BEHAVIORAL

Patient Navigation (PN) Group

The patient navigator approach includes five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community based activity.

BEHAVIORAL

Patient Navigator Plus Contingency Management (PN+CM) Group

Study participants randomized to this group will receive the patient navigation (PN) intervention as outlined above combined with contingency management (CM).

Sponsors & Collaborators

• Jackson Health System

  collaborator OTHER

• Grady Health System

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Boston Medical Center

  collaborator OTHER

• Hahnemann University Hospital

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• PARKLAND HEALTH AND HUMAN SERVICES

  collaborator UNKNOWN

• University of Pittsburgh

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• St. Luke's-Roosevelt Hospital Center

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Lisa Metsch, Ph.D · Columbia University

• Lauren Gooden, 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

2012-07-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• United States

Study Locations