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

Primary Purpose

HIV, Mental Illness

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Use of Memory Aids to take medications
Sponsored by
National Institute of Nursing Research (NINR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Mental Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of serious mental illness; HIV positive Exclusion Criteria: None

Sites / Locations

  • Center for Mental Health Services and Policy Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1 - Experimental

2 - Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 9, 2005
Last Updated
October 3, 2008
Sponsor
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00264823
Brief Title
Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)
Official Title
Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Mental Illness
Keywords
HIV, Mental Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Experimental
Arm Type
Experimental
Arm Title
2 - Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Use of Memory Aids to take medications
Intervention Description
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 Outcome Measure Information:
Title
How to best help people with serious mental illness follow HIV treatment regimens
Time Frame
baseline, 3, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of serious mental illness; HIV positive Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Blank, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Mental Health Services and Policy Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28536741
Citation
Dalseth N, Reed RS, Hennessy M, Eisenberg MM, Blank MB. Does Diagnosis Make a Difference? Estimating the Impact of an HIV Medication Adherence Intervention for Persons with Serious Mental Illness. AIDS Behav. 2018 Jan;22(1):265-275. doi: 10.1007/s10461-017-1795-5.
Results Reference
derived
PubMed Identifier
25535041
Citation
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.
Results Reference
derived
PubMed Identifier
24000053
Citation
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.
Results Reference
derived

Learn more about this trial

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

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