Reducing HIV Stigma to Improve Health Outcomes for African-American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Change in stigma scores from baseline to 12 months.
研究概览
简要总结
African American women account for 66% of HIV infections in women in the U.S., AIDS is a leading cause of death for African American women, and African Americans have the lowest medication adherence rates compared to other groups in the U.S. One of the reasons for low medication adherence among African Americans is fear of stigma. HIV stigma has been linked to depression, psychological distress, poor quality of life, poor medication adherence and service utilization contributing to morbidity and mortality. Research has found that stigma is a moderator to poor adherence via depressive symptoms.
The current study is a randomized control trial with a time and attention control group to test the effectiveness of a stigma reduction intervention adapted for use with African American women. A total of 224 African American women will be recruited to participate in the study. Half of the women will be from Chicago, Illinois (112) and the other half will be from Birmingham, Alabama (112). A workshop will be held once a study site has recruited 28 women, half of the women will be in the intervention group (14) and the other half will be in the control group (14). Each study site will have 4 cohorts of 28 women.
The main aims of the current study are:
- to determine the long-term effectiveness of the intervention to reduce stigma for African American women living with HIV in Chicago Illinois and Birmingham, Alabama
- to examine whether stigma reduction due to the intervention is associated with improved physical health biomarkers (CD4+ T cell count, viral load), mediated by reduced psychological symptoms (depressive symptoms), improved engagement to care, and improved medication adherence
- to explore whether stigma reduction due to the intervention is moderated by location (Chicago vs. Birmingham), transmission risk factor, time since diagnosis, and perceived social support
We expect that the multimedia workshop intervention will demonstrate effectiveness in reducing internalized stigma through an easily-disseminated method, and that it will have a positive impact on medication adherence and engagement in care for African American women living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •they are women who identify as having an African American racial/ethnic background
- •born in the U.S. (including women of Caribbean origin if born in the U.S.
- •speak and understand English as their primary language of communication outside the home
- •they are 18 years of age or older
- •have a documented HIV positive status (women are on antiretroviral treatment and women who are not on antiretroviral are eligible)
- •able to see and interact with a touchscreen computer in English.
排除标准
- •women who not self-identify as African American
- •women who are African born or born outside the United States
- •younger than 18 years of age
- •unable to provide informed consent
- •life expectancy less than 1 year per physician report
- •unable to see and interact with a touchscreen computer in English.
结局指标
主要结局
Change in stigma scores from baseline to 12 months.
时间窗: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
We will see if the intervention/workshop reduces HIV related stigma after 1 year in the study. We will use the Stigma Scale for Chronic Illness to measure stigma.
次要结局
- Post-Traumatic Stress Disorder Checklist(baseline, 12 months)
- Adherence to HIV Medication(baseline, after intervention, 4 months, 6 months, 8 months, 12 months)
- Patient Health Questionnaire (PHQ-9)(baseline, after intervention, 4 months, 6 months, 8 months, 12 months)
- Location as a moderator variable(baseline, after intervervention, 4 months, 6 months, 8 months, 12 months)
- Medical Outcomes Study Social Support Scale(Study duration)
- substance abuse(baseline, 12 months)
- Engagement in Care (from patient record)(baseline, 4 months, 8 months, 12 months)
- HIV viral load (from medical chart) over 1 year study duration(baseline, 4 months, 8 months, 12 months)
- Change in CD4 count(baseline, 4 months, 8 months, 12 months)
研究者
Deepa Rao
Associate Professor, Department of Global Health
University of Washington