A Pilot Study to Improve Functional Health Health Status in Minority Women Living With HIV
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Viral Load
研究概览
简要总结
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.
详细描述
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:
- To describe patterns of health, wellness, protocol adherence CD4 counts, viral load and Functional Health Status.
- To test the effect of a guided imagery intervention on HAART Adherence, Viral load, CD4 Counts and Functional Health Status.
- To test the effect of a cognitive power intervention on HAART Adherence, Viral load, CD4 Counts and Functional Health and Functional Health Status..
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women participants diagnosed with HIV
- •Must speak and write in English
排除标准
- •Women participants with debilitating complications
- •Women participants with Cognitive Impairment
结局指标
主要结局
Viral Load
时间窗: Twenty-one days following the baseline
Sero blood assessment of amount of HIV virus
SF-36v2 Health Survey
时间窗: Twenty-one days after the baseline
Functional Health from the participants perspective
Power as Knowing Participation in Change (PKPCT)
时间窗: Twenty-one days after the baseline.
Subjects Power Profile to Create Change
CD4 Counts
时间窗: Measured 21 days after the baseline
Cells in human body measure response immune system to infection
次要结局
未报告次要终点