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OpenTrials
Completed

NCT Number: NCT00264823

Nursing Intervention for HIV Regime Adherence Among People With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Mental Health Services and Policy Research

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of serious mental illness; HIV positive

Exclusion criteria

  • None

Treatment and study plan

Use of Memory Aids to take medications

Behavioral

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.

Primary outcomes

  1. How to best help people with serious mental illness follow HIV treatment regimens

    Time frame: baseline, 3, 12 and 24 months

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Dec 13, 2005
Registry last updated
Oct 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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