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

This study has been completed.

Sponsor:

Information provided by:

National Institute of Nursing Research (NINR)

ClinicalTrials.gov Identifier:

NCT00264823

First received: December 9, 2005

Last updated: October 3, 2008

Last verified: October 2008

History of Changes

Purpose

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: Open Label Primary Purpose: Treatment
Official Title:	Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Mental Disorders

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]


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

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.

Eligibility


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

Criteria

Inclusion Criteria:

Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

Wu ES, Rothbard A, Holtgrave DR, Blank MB. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV. Community Ment Health J. 2016 May;52(4):439-45. doi: 10.1007/s10597-014-9788-6. Epub 2014 Dec 23.

Blank MB, Hennessy M, Eisenberg MM. Increasing quality of life and reducing HIV burden: the PATH+ intervention. AIDS Behav. 2014 Apr;18(4):716-25. doi: 10.1007/s10461-013-0606-x.


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
Study First Received:	December 9, 2005
Last Updated:	October 3, 2008
Health Authority:	United States: Federal Government

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


HIV Mental Illness

Additional relevant MeSH terms:


Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016

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