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Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)

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ClinicalTrials.gov Identifier: NCT00264823
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : October 6, 2008
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.

Condition or disease Intervention/treatment Phase
HIV Mental Illness Behavioral: Use of Memory Aids to take medications Phase 2

Detailed Description:
There is concern that HIV positive SMI persons may be a greater risk for poor treatment adherence, increasing risk for poorer outcomes and development of treatment resistance virus, and also placing others at greater risk. Involvement of advance practice nurses has been previously shown to improve outcomes for persons with HIV/AIDS.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)
Study Start Date : June 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1 - Experimental Behavioral: Use of Memory Aids to take medications
Experimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy.
No Intervention: 2 - Control


Outcome Measures
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Primary Outcome Measures :
  1. How to best help people with serious mental illness follow HIV treatment regimens [ Time Frame: baseline, 3, 12 and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264823


Locations
United States, Pennsylvania
Center for Mental Health Services and Policy Research
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Michael Blank, PhD University of Pennsylvania
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael B. Blank, PhD, Center for Mental Health Policy and Services Research Department of Psychiatry University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00264823     History of Changes
Other Study ID Numbers: 708134
5R01NR008851-03 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: October 2008

Keywords provided by National Institute of Nursing Research (NINR):
HIV
Mental Illness

Additional relevant MeSH terms:
Mental Disorders