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NCT00264823 Clinical Trial

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

HIV Clinical Trial

Official title:
Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00264823
Other study ID # 708134
Secondary ID 5R01NR008851-03
Status Completed
Phase Phase 2
First received December 9, 2005
Last updated October 3, 2008
Start date June 2003
Est. completion date May 2008

Study information
Verified date October 2008
Source National Institute of Nursing Research (NINR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 273
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Center for Mental Health Services and Policy Research Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary How to best help people with serious mental illness follow HIV treatment regimens baseline, 3, 12 and 24 months No
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