Improve Functional Health Status in Minority Women With HIV
A Pilot Study to Improve Functional Health Health Status in Minority Women Living With HIV
1 other identifier
interventional
80
1 country
1
Brief Summary
HIV is no longer a death sentence, and with adherence to Rapid High Activity Antiretroviral (HAART) protocol women with HIV can achieve a normal life expectancy. In New Jersey there are 11,724 (32.9%) women living with HIV with Essex county in the lead, and they come they come from lowest social strata and educational level and are often single mothers. The purpose of this study is test three study interventions: a cognitive health promotion intervention, a guided imagery intervention and combination of both interventions. The Significance of the study is to improve the functional health and protocol adherence, to better enable women with HIV to achieve a normal life expectancy. The Methodology is an intervention study that uses a classic four group pretest post-test experimental design with random assignment, and the subjects for the study will be 80 women living with HIV. The interventions will be delivered within a three-week time frame followed by post testing at the end of the third week in Newark,New Jersey. The results of this study will be used as preliminary data to support a grant proposal to be submitted to the National Institutes of Health. The Results of this study are important as they will support improved health function and adherence to treatment protocols for marginalized poor women with HIV to achieve outcomes on par with men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 19, 2020
March 1, 2020
9 months
February 28, 2020
March 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
CD4 Counts
Cells in human body measure response immune system to infection
Measured at the baseline
CD4 Counts
Cells in human body measure response immune system to infection
Measured 21 days after the baseline
Viral Load
Sero blood assessment of amount of HIV virus.
At the baseline
Viral Load
Sero blood assessment of amount of HIV virus
Twenty-one days following the baseline
SF-36v2 Health Survey
Functional Health from the participants perspective
At the baseline
SF-36v2 Health Survey
Functional Health from the participants perspective
Twenty-one days after the baseline
Power as Knowing Participation in Change (PKPCT)
Subjects Power Profile to Create Change
At the Baseline.
Power as Knowing Participation in Change (PKPCT)
Subjects Power Profile to Create Change
Twenty-one days after the baseline.
Study Arms (4)
Guided Imagery Intervention
EXPERIMENTALParticipants randomly assigned to this group will be provided with a MP3 Player which will have three guided imagery programs The Guided Imagery Programs include: 1.) Relaxation and Wellness; 2.) Immune System Imagery; and 3.) Healing Trauma.
Cognitive Power Intervention
EXPERIMENTALThe participant who is randomly assigned to this group completes The Power as Knowing Participation in Change Version II (PKPCT) to determine 1.) Freedom to Act Intentionally, 2.) Involvement in Creating Change, 3.) Freedom to Act Intentionally and 4.) My Involvement in Creating Change.
Cognitive Power Intervention and Guided Imagery
EXPERIMENTALThe participant is randomly assigned to this group completes both the Guided Imagery Intervention and the Cognitive Power Intervention.
Control Group
NO INTERVENTIONThe participant is randomized to the control group and completes all study measures twenty-one days after the baseline data are competed. .
Interventions
The participant listens to a selected Guided Imagery for 21 consecutive days.
The participant develops a plan to achieve healthy outcomes and reviews plan for 21 consecutive days.
The participant completes 21 days of selected Guided Imagery in combination with the development of a plan to achieve healthy outcomes and reviews the plan for 21 days.
Eligibility Criteria
You may qualify if:
- Women participants diagnosed with HIV
- Must speak and write in English
You may not qualify if:
- Women participants with debilitating complications
- Women participants with Cognitive Impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seton Hall University, College of Nursing
Nutley, New Jersey, 07110, United States
Related Publications (4)
Barrett EA. Power as knowing participation in change: what's new and what's next. Nurs Sci Q. 2010 Jan;23(1):47-54. doi: 10.1177/0894318409353797.
PMID: 20026728BACKGROUNDCaroselli C, Barrett EA. A review of the power as knowing participation in change literature. Nurs Sci Q. 1998 Spring;11(1):9-16. doi: 10.1177/089431849801100105.
PMID: 9555424BACKGROUNDHansell PS, Hughes CB, Caliandro G, Russo P, Budin WC, Hartman B, Hernandez OC. The effect of a social support boosting intervention on stress, coping, and social support in caregivers of children with HIV/AIDS. Nurs Res. 1998 Mar-Apr;47(2):79-86. doi: 10.1097/00006199-199803000-00006.
PMID: 9536191BACKGROUNDHansell PS, Hughes CB, Caliandro G, Russo P, Budin WC, Hartman B, Hernandez OC. Boosting social support in caregivers of children with HIV/AIDS. AIDS Patient Care STDS. 1999 May;13(5):297-302. doi: 10.1089/apc.1999.13.297.
PMID: 10356809BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Phyllis S Hansell, EdD
Seton Hall University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2020
First Posted
March 19, 2020
Study Start
April 1, 2020
Primary Completion
December 30, 2020
Study Completion
December 31, 2020
Last Updated
March 19, 2020
Record last verified: 2020-03