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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264823
First Posted: December 13, 2005
Last Update Posted: October 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Nursing Research (NINR)
December 9, 2005
December 13, 2005
October 6, 2008
June 2003
May 2008   (Final data collection date for primary outcome measure)
How to best help people with serious mental illness follow HIV treatment regimens [ Time Frame: baseline, 3, 12 and 24 months ]
How to best help people with serious mental illness follow HIV treatment regimens
Complete list of historical versions of study NCT00264823 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)
Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV
  • Mental Illness
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.
  • Experimental: 1 - Experimental
    Intervention: Behavioral: Use of Memory Aids to take medications
  • No Intervention: 2 - Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
273
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00264823
708134
5R01NR008851-03 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Michael B. Blank, PhD, Center for Mental Health Policy and Services Research Department of Psychiatry University of Pennsylvania
National Institute of Nursing Research (NINR)
Not Provided
Principal Investigator: Michael Blank, PhD University of Pennsylvania
National Institute of Nursing Research (NINR)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP