Skip to main content
Clinical Trials/NCT01893112
NCT01893112
Completed
Not Applicable

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

University of Washington2 sites in 1 country240 target enrollmentJune 2013
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of Washington
Enrollment
240
Locations
2
Primary Endpoint
Change in stigma scores from baseline to 12 months.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
February 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deepa Rao

Associate Professor, Department of Global Health

University of Washington

Eligibility 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.

Outcomes

Primary Outcomes

Change in stigma scores from baseline to 12 months.

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (2)

Loading locations...

Similar Trials