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

Completed · Not applicable

Conditions studied: HIV, AIDS, Substance Abuse, Inpatient

In brief

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.

Key facts

Study ID

NCT01612169

Run by

Columbia University

People needed

801

Starts

2012-07-01

Expected to finish

2015-06-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participating individuals must:
• be admitted to a hospital and be HIV-infected at the time of recruitment
• be at least 18 years old
• meet one of the following: A) have an AIDS-defining illness during the current hospital admission; or B) have the most recent CD4 count and viral load performed within the past 6 months be <350 cells/uL and >200 copies/mL; or C) have the most recent CD4 count and viral load performed within the past 12 months be <=500 cells/uL and >200 copies/mL or unknown accompanied by the Site PI's discretion that the patient a) is likely to currently have a viral load >200 copies/mL, b) is not currently successfully/correctly taking antiretroviral therapy (ART) and c) needs to be on ART
• report (or have evidence in the medical record of) any opioid and/or stimulant and/or heavy alcohol use within the past 12 months (Note: Medical record evidence may consist of a) positive toxicology screen(s) for stimulants or heavy alcohol or b) clinician notes indicating heavy use of alcohol, use of stimulants or non-prescribed opioids or abuse of prescribed opioids.)
• have a Karnofsky performance scale index score of >=60
• provide informed consent
• provide locator information
• sign a HIPAA form / medical record release form to facilitate medical record abstraction
• report living in the vicinity and being able to return for follow-up visits
• complete the baseline assessment, including blood draw
• be able to communicate in English

You may not qualify if…

• Individuals will be excluded from the study if they:
• do not meet any one or more of the above-described inclusion criteria
• have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
• are terminated via Site PI decision with agreement from study Lead Investigator

Where it is running

• University Hospital At University of Alabama, Birmingham (Uab) — Birmingham, Alabama, United States
• Los Angeles County Harbor-UCLA Medical Center — Torrance, California, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Stroger Cook County Hospital/Rush University Medical Center — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Saint Luke's Roosevelt Hospital Center — New York, New York, United States
• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center (Upmc) — Pittsburgh, Pennsylvania, United States
• Parkland Health and Human Services — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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