Reducing HIV Stigma for African American Women
2017年5月3日 更新者：Deepa Rao、University of Washington
Reducing HIV Stigma to Improve Health Outcomes for African-American Women
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.
研究概览
研究类型
介入性
注册 (实际的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35233
- University of Alabama Birmingham
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University (NU)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Unity Workshop
The intervention is a workshop facilitated by a peer advocate (an African American woman who is also HIV positive) and a social worker.
It has exercises, videos and group discussions intended to equip participants with coping skills to overcome HIV related stigma and the negative outcomes related to stigma.
The workshop will last about 8 hours total across 2 two days (4 hours per day).
The researcher in the current study has done a lot of work in adapting this intervention for African American women.
The workshop has been piloted in Seattle and had promising results.
Based on results in the pilot study, a 2 hour booster session has been added 6 months after the initial workshop
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The intervention is based on other stigma reduction programs that are being used internationally (HIV Stigma Toolkit developed by the International Center for Research on Women and trigger videos developed by International Training & Education Center for health).
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其他：Breast Cancer Screening
The time and attention control group workshop will be facilitated by a research coordinator.
The control group program is based on another program that is designed explore issues related to breast cancer screening among African American women.
The program has the same format as the Unity Workshop, with video and group discussion.
Although breast cancer may be associated with stigma, we anticipated that breast cancer stigmas would not be related to HIV-associated stigma, which is our primary outcome of interest.
The control groups will be held during the same week as the Unity Workshops, and control group participants will complete assessments on the same schedule as the Unity Workshop participants.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in stigma scores from baseline to 12 months.
大体时间：baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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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.
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baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Location as a moderator variable
大体时间：baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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This is a multi-site study (Chicago and Birmingham) and we are interested in seeing if location is a moderating variable
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baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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Post-Traumatic Stress Disorder Checklist
大体时间：baseline, 12 months
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baseline, 12 months
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Adherence to HIV Medication
大体时间：baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.
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baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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Patient Health Questionnaire (PHQ-9)
大体时间：baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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We will look at the correlation between stigma scores and depression scores over time.
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baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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Medical Outcomes Study Social Support Scale
大体时间：Study duration
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We are going to use a validated social support scale, and analyze social support as a correlate.
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Study duration
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substance abuse
大体时间：baseline, 12 months
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substance use and stigma of substance use will be measured using: Alcohol Use disorders Identification Test (AUDIT) Severity of Dependence Scale (SDS) Substance Abuse Self Stigma (SASS)
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baseline, 12 months
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Engagement in Care (from patient record)
大体时间：baseline, 4 months, 8 months, 12 months
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Research assistants will access participants' medical records to see if patients have missed any HIV related visits (i.e.
medical, counseling).
Engagement to care will be measured as a proportion (missed visits over total scheduled).
Rescheduled visits will not count as missed visits.
At baseline, we will look at visits for the past 12 months.
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baseline, 4 months, 8 months, 12 months
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HIV viral load (from medical chart) over 1 year study duration
大体时间：baseline, 4 months, 8 months, 12 months
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We want to examine whether stigma reduction due to the intervention is associated with improved physical health bio-markers such as suppression in HIV viral load in the blood (taken from medical chart/previous clinical blood tests).
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baseline, 4 months, 8 months, 12 months
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Change in CD4 count
大体时间：baseline, 4 months, 8 months, 12 months
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We want to see wither stigma reduction from the intervention associated with improved physical health bio-markers such as CD4+ T cell count.
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baseline, 4 months, 8 months, 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Deepa Rao, PhD, MA、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Rao D, Kekwaletswe TC, Hosek S, Martinez J, Rodriguez F. Stigma and social barriers to medication adherence with urban youth living with HIV. AIDS Care. 2007 Jan;19(1):28-33. doi: 10.1080/09540120600652303.
- Rintamaki LS, Davis TC, Skripkauskas S, Bennett CL, Wolf MS. Social stigma concerns and HIV medication adherence. AIDS Patient Care STDS. 2006 May;20(5):359-68. doi: 10.1089/apc.2006.20.359.
- CDC. HIV/AIDS Surveillance Report: Cases of HIV infection and AIDS in the United States. 2004.
- CDC. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. Leading Cause of Death for Black Women 1999-2007. 2008; www.cdc.gov/ncipc/wisqars. Accessed December 4, 2011.
- Halkitis PN, Parsons JT, Wolitski RJ, Remien RH. Characteristics of HIV antiretroviral treatments, access and adherence in an ethnically diverse sample of men who have sex with men. AIDS Care. 2003 Feb;15(1):89-102. doi: 10.1080/095401221000039798.
- Palacio H, Kahn JG, Richards TA, Morin SF. Effect of race and/or ethnicity in use of antiretrovirals and prophylaxis for opportunistic infection: a review of the literature. Public Health Rep. 2002 May-Jun;117(3):233-51; discussion 231-2. doi: 10.1093/phr/117.3.233.
- Traeger L, O'Cleirigh C, Skeer MR, Mayer KH, Safren SA. Risk factors for missed HIV primary care visits among men who have sex with men. J Behav Med. 2012 Oct;35(5):548-56. doi: 10.1007/s10865-011-9383-z. Epub 2011 Nov 9.
- Rao D, Feldman BJ, Fredericksen RJ, Crane PK, Simoni JM, Kitahata MM, Crane HM. A structural equation model of HIV-related stigma, depressive symptoms, and medication adherence. AIDS Behav. 2012 Apr;16(3):711-6. doi: 10.1007/s10461-011-9915-0.
- Rao D, Desmond M, Andrasik M, Rasberry T, Lambert N, Cohn SE, Simoni J. Feasibility, acceptability, and preliminary efficacy of the unity workshop: an internalized stigma reduction intervention for African American women living with HIV. AIDS Patient Care STDS. 2012 Oct;26(10):614-20. doi: 10.1089/apc.2012.0106. Epub 2012 Sep 17.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年6月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2017年2月1日
研究注册日期
首次提交
2013年2月11日
首先提交符合 QC 标准的
2013年7月1日
首次发布 (估计)
2013年7月8日
研究记录更新
最后更新发布 (实际的)
2017年5月8日
上次提交的符合 QC 标准的更新
2017年5月3日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 43970
- R01MH098675 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.