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

This study has been completed.
Information provided by:
National Institute of Nursing Research (NINR) Identifier:
First received: December 9, 2005
Last updated: October 3, 2008
Last verified: October 2008
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 Intervention Phase
HIV Mental Illness Behavioral: Use of Memory Aids to take medications Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by National Institute of Nursing Research (NINR):

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

Enrollment: 273
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

Inclusion Criteria:

  • Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00264823

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)
Principal Investigator: Michael Blank, PhD University of Pennsylvania
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael B. Blank, PhD, Center for Mental Health Policy and Services Research Department of Psychiatry University of Pennsylvania Identifier: NCT00264823     History of Changes
Other Study ID Numbers: 708134
5R01NR008851-03 ( U.S. NIH Grant/Contract )
Study First Received: December 9, 2005
Last Updated: October 3, 2008

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

Additional relevant MeSH terms:
Mental Disorders processed this record on September 20, 2017