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: 1. 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 2. 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 3. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
240
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).
University of Alabama Birmingham
Birmingham, Alabama, United States
Northwestern University (NU)
Chicago, Illinois, United States
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.
Time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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
Time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Post-Traumatic Stress Disorder Checklist
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: baseline, 4 months, 8 months, 12 months
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