Clinical trial NCT04315675: Improve Functional Health Status in Minority Women With HIV
Official title: A Pilot Study to Improve Functional Health Health Status in Minority Women Living With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Keywords: Promoting functional health
Lead sponsor: Seton Hall University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a quantitative intervention study that tests and compares outcomes of three interventions and a control group. The subjects are randomly assigned to one of four study groups.
Primary purpose: PREVENTION

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.

Detailed description: Background: Among the more than one million persons in the United States living with HIV/AIDS, women comprise approximately 25% or 280,000 of persons infected with HIV (CDC, 2015). According to The CDC (2015) in 2010 there were 7800 new cases of HIV in women. Black/African American Women accounted for 5,300 of these women, followed by 1200 Hispanic/Latino women who were newly diagnosed with HIV.

The women with HIV/AIDS in the United States largely come disproportionately from minorities who are marginalized at the lowest strata of society with Black and Hispanic inner city women accounting for approximately 80% of all cases.The fourth leading cause of death in Black women, HIV/AIDs is a disease of poor women who count HIV as not the main problem, but one of more than a dozen life challenges that they encounter in their day to day living. (Hansell, Hughes, Caliandro, Budin,1999). HIV in women affects the entire family especially the children of these women who lead a highly deprived and compromised life. The day to day challenges that these women encounter to stay alive causes them to struggle to maintain their own health with quality lives and to adequately provide for their children. By comparison men with HIV tend to come from a higher social stratum have a higher level of educational and professional attainment. The current treatment for HIV/AIDS is High Activity Antiretroviral therapy (HAART) which provides a simple one pill regimen taken daily. This HIV regimen is highly effective in reducing viral load and an increasing CD4 counts. The HIV disease process is effectively managed by HAART and mitigates the progression of disease thus rendering it a chronic disease state. With the effective management of HIV, it is critical for the person to adhere to the HAART Protocol, as well as manage one's own health status through a better understanding of health promotion and disease prevention. Purpose: The purpose of this study is to test interventions for women with HIV/AIDS aimed at improving their functional health status and protocol adherence by promoting positive health behaviors enabling them to achieve higher functional health. These results will be used as preliminary data for an NIH grant proposal for a large-scale intervention study on the HAART protocol adherence and the functional health of women with HIV/AIDS.

Specific Aims:

The Specific aims for this study are focused on women living with HIV are as follows:

1. To describe patterns of health, wellness, protocol adherence CD4 counts, viral load and Functional Health Status.
2. To test the effect of a guided imagery intervention on HAART Adherence, Viral load, CD4 Counts and Functional Health Status.
3. To test the effect of a cognitive power intervention on HAART Adherence, Viral load, CD4 Counts and Functional Health and Functional Health Status..
4. To test the effect of a combined guided imagery intervention in combination with Cognitive Power Intervention on HAART adherence, Viral Load, CD4 Counts and Functional Health Status

The outcome variables will be generated by the study measures and will include: CD4 counts; Viral Load; the EF-36v2 Health Survey and the Power as Knowing Participation in Change (PKPCT)Tool.

Significance:Women living with HIV/AIDS are largely from medically under-served communities and are primarily from minority populations. Women living with HIV/AIDS who are adhere to their HIV treatment protocol need to make choices that promote their functional health and prevent co-morbidity which will enable them to lead normal lives and become more productive members of society.

Conceptual Framework: Barrett's Power as Knowing Participation in Change Theory provides the framework for this study. Barrett "Power is Knowing Participation in Change conveys the notion that power is the capacity to participate knowingly in change which is manifest by awareness, choices, freedom to act intentionally and involvement in creating change. The two types of power are: power as control and power as freedom. The overall focus in this study is to aid subjects to effectively deploy their power to best enable the best possible achievement of improved health function.

Methodology: This study is a quantitative intervention study that tests and compares outcomes of three interventions and a control group. The design is a classic pretest control group design that includes three intervention groups that will be compared to a control group. Within this design subjects are randomly assigned to one of the four study groups:

1. Group One R Pre-test X (Guided Imagery Intervention) Post Test n=20.
2. Group Two R Pre-test Y (Cognitive Power Intervention) Post Test n=20.
3. Group Three R Pre-test XY (Combination Intervention Post Test n=20.
4. Control Group Post Test n=20.

Total Number of Subjects 80

Subjects: Subjects are women with HIV who are compliant on a HAART treatment protocol. With four groups a sample of 80 subjects is projected with 20 subjects per group. Subjects with multi-system or debilitating complications, limited cognitive or language will be excluded from the sample.

Instrumentation/ Study Measures: Background Demographic Questionnaire- baseline data regarding age, sex, marital status, health status, HIV history, Family structure, treatment plan. CD4 counts- CD4 measures CD4 cells that are in a human body. CD4 cells play an important role in the immune system to infection. CD4( Cluster of Differential 4) counts below 200 place an individual at high risk for serious illnesses. The normal CD4 count in HIV sero-negative persons ranges between 460 and 1600. CD4 counts are standard in HAART protocols. Viral Load- Viral load is a blood test that measures how much HIV is in a person's body. Patients on HIV treatment protocol have been tested for viral load. SF-36v2 Health Survey- The Optimum TM SF 36v2 Health Survey asks 36 questions to measure functional health from the patient's perspective. The higher the score the higher the Health Function.The Power as Knowing Participation in Change Tool (PKPCT is based upon the four dimensions of power which are: awareness; choices:freedom to act intentionally and involvement in creating change (Barrett, 2003). Power as knowing participation is being aware of what one is choosing to do, and doing it intentionally. Awareness and freedom to act intentionally guide choices and involvement in creating changes. Power is freedom to make aware choices for life situations including health promoting changes. Free to act as one wishes is critical to power. Awareness is the focusing of attention on what one perceives to exists. Choices are selections from possibilities for participating in experiences Freedom to act intentionally is the experience of one's capacity to do or bring about what one has in mind. Involvement in creating change is innovative engagement in the unpredictable human-environment mutual process to actualize some potential. The score range for each scale is 12-84 and for the total scale 48-336. Lower scores indicate less power and higher scores indicate higher power.

Procedures: After informed consent is obtained, subjects are randomly assigned to one of four study groups. Baseline data are collected and for participants in the intervention groups their assigned intervention begin.

Interventions: Guided Imagery- is an intervention based on the mind body connection whereby thoughts guide the imagination toward a relaxed and focused state. Sessions will be completed for 21 consecutive days beginning at the baseline with measures again repeated 21 days post baseline. The Cognitive Power Intervention on Health Function- The cognitive power intervention on health function uses the subject's power profile to set attainable goals to act intentionally to create specific changes in one's life aimed at the improvement of the participants' Health Function.

Statistical Analysis: The analysis will include both descriptive and multivariate analysis to test for differences between study groups using the .05 level of significance to test for differences.

Results/Outcomes: These results will provide preliminary data for a large scale NIH grant proposal. The study will determine if women living with HIV using study interventions are able to achieve improved health function which ultimately will contribute an improved life expectancy. These results can be useful as a model to improve health function in women with chronic diseases (Diabetes, Cancer Cardiac etc.)

References:

Henry Kaiser Foundation. (2014) Women in HIV AIDS in the United States. New Jersey Department of Health and Human Services. HIV/AIDS among Women in New Jersey, 2016. Statistics Center/HIV/AIDS 2016 and 2017) https//www.cdc.gov.hiv.overview.

Eligibility criteria: Inclusion Criteria:

* Women participants diagnosed with HIV
* Must speak and write in English

Exclusion Criteria:

* Women participants with debilitating complications
* Women participants with Cognitive Impairment

Primary outcomes:
measure: CD4 Counts
timeFrame: Measured at the baseline
measure: CD4 Counts
timeFrame: Measured 21 days after the baseline
measure: Viral Load
timeFrame: At the baseline
measure: Viral Load
timeFrame: Twenty-one days following the baseline
measure: SF-36v2 Health Survey
timeFrame: At the baseline
measure: SF-36v2 Health Survey
timeFrame: Twenty-one days after the baseline
measure: Power as Knowing Participation in Change (PKPCT)
timeFrame: At the Baseline.
measure: Power as Knowing Participation in Change (PKPCT)
timeFrame: Twenty-one days after the baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Seton Hall University, College of Nursing
state: New Jersey
Study officials:
affiliation: Seton Hall University
name: Phyllis S Hansell, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Caroselli 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.
citation: Hansell 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.
citation: Hansell 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.