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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Mental Illness | Behavioral: Use of Memory Aids to take medications | Phase 2 |
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 |
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.
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No Intervention: 2 - Control |
- How to best help people with serious mental illness follow HIV treatment regimens [ Time Frame: baseline, 3, 12 and 24 months ]

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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:

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
United States, Pennsylvania | |
Center for Mental Health Services and Policy Research | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Michael Blank, PhD | University of Pennsylvania |
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 |