Reducing HIV Stigma for African American Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Washington
Sponsor:
Collaborators:
University of Alabama at Birmingham
Northwestern University
Information provided by (Responsible Party):
Deepa Rao, University of Washington
ClinicalTrials.gov Identifier:
NCT01893112
First received: February 11, 2013
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
HIV
Behavioral: Unity Workshop
Behavioral: Breast Cancer Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Reducing HIV Stigma to Improve Health Outcomes for African-American Women

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in stigma scores from baseline to 12 months. [ Time Frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Location as a moderator variable [ Time Frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    This is a multi-site study (Chicago and Birmingham) and we are interested in seeing if location is a moderating variable

  • Post-Traumatic Stress Disorder Checklist [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
  • Adherence to HIV Medication [ Time Frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    We will look at the correlation between stigma scores and depression scores over time.

  • Medical Outcomes Study Social Support Scale [ Time Frame: Study duration ] [ Designated as safety issue: No ]
    We are going to use a validated social support scale, and analyze social support as a correlate.

  • substance abuse [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    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)

  • Engagement in Care (from patient record) [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    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.

  • HIV viral load (from medical chart) over 1 year study duration [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    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).

  • Change in CD4 count [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]
    We want to see wither stigma reduction from the intervention associated with improved physical health bio-markers such as CD4+ T cell count.


Estimated Enrollment: 224
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Behavioral: Unity Workshop
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).
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.
Behavioral: Breast Cancer Screening

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893112

Locations
United States, Alabama
University of Alabama Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Michael J Mugavero, MD, MHSc    205-996-5822    mmugavero@uab.edu   
Contact: Janet Turan, PhD, MPH    (205) 934-6780    jmturan@uab.edu   
Principal Investigator: Michael J Mugavero, MD, MHSc         
United States, Illinois
Northwestern University (NU) Recruiting
Chicago, Illinois, United States, 60611
Contact: Susan E Cohn, MD, MPH    312-926-3693    susan-cohn@northwestern.edu   
Contact: Baiba Berzins    312-695-5012    baiba@northwestern.edu   
Principal Investigator: Susan E Cohn, MD, MPH         
Sponsors and Collaborators
University of Washington
University of Alabama at Birmingham
Northwestern University
Investigators
Principal Investigator: Deepa Rao, PhD, MA University of Washington
  More Information

Publications:
Responsible Party: Deepa Rao, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01893112     History of Changes
Other Study ID Numbers: R01MH098675
Study First Received: February 11, 2013
Last Updated: July 1, 2013
Health Authority: United States: Data and Safety Monitoring Board

ClinicalTrials.gov processed this record on September 22, 2014