Reducing HIV Stigma for African American Women

Study Overview
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Brief Summary
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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.

Official Title
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Reducing HIV Stigma to Improve Health Outcomes for African-American Women

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Unity Workshop
* Behavioral: Breast Cancer Screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unity Workshop<br>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 | Behavioral: Unity Workshop<br>* 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).<br>|
| Other: Breast Cancer Screening<br>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. | Behavioral: Breast Cancer Screening<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stigma scores from baseline to 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. | baseline, after intervervention, 4 months, 6 months, 8 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location as a moderator variable | This is a multi-site study (Chicago and Birmingham) and we are interested in seeing if location is a moderating variable | baseline, after intervervention, 4 months, 6 months, 8 months, 12 months | 
| Post-Traumatic Stress Disorder Checklist |  | baseline, 12 months | 
| Adherence to HIV Medication | Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions. | baseline, after intervention, 4 months, 6 months, 8 months, 12 months | 
| Patient Health Questionnaire (PHQ-9) | We will look at the correlation between stigma scores and depression scores over time. | baseline, after intervention, 4 months, 6 months, 8 months, 12 months | 
| Medical Outcomes Study Social Support Scale | We are going to use a validated social support scale, and analyze social support as a correlate. | Study duration | 
| substance abuse | 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) | baseline, 12 months | 
| Engagement in Care (from patient record) | 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. | baseline, 4 months, 8 months, 12 months | 
| HIV viral load (from medical chart) over 1 year study duration | 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). | baseline, 4 months, 8 months, 12 months | 
| Change in CD4 count | We want to see wither stigma reduction from the intervention associated with improved physical health bio-markers such as CD4+ T cell count. | baseline, 4 months, 8 months, 12 months |