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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00264823
Enrollment
273
Registered
2005-12-13
Start date
2003-06-30
Completion date
2008-05-31
Last updated
2008-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Mental Illness

Keywords

HIV, Mental Illness

Brief 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.

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.

Interventions

BEHAVIORALUse 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.

Sponsors

National Institute of Nursing Research (NINR)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of serious mental illness; HIV positive

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
How to best help people with serious mental illness follow HIV treatment regimensbaseline, 3, 12 and 24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026