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Completed

NCT Number: NCT01893112

Reducing HIV Stigma 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:

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unity Workshop

Behavioral

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

Behavioral

Primary outcomes

  1. 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

  1. Location as a moderator variable

    Time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months

    This is a multi-site study (Chicago and Birmingham) and we are interested in seeing if location is a moderating variable

  2. Post-Traumatic Stress Disorder Checklist

    Time frame: baseline, 12 months

  3. Adherence to HIV Medication

    Time frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months

    Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.

  4. Patient Health Questionnaire (PHQ-9)

    Time frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months

    We will look at the correlation between stigma scores and depression scores over time.

  5. Medical Outcomes Study Social Support Scale

    Time frame: Study duration

    We are going to use a validated social support scale, and analyze social support as a correlate.

  6. substance abuse

    Time frame: baseline, 12 months

    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)

  7. Engagement in Care (from patient record)

    Time frame: baseline, 4 months, 8 months, 12 months

    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.

  8. HIV viral load (from medical chart) over 1 year study duration

    Time frame: baseline, 4 months, 8 months, 12 months

    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).

  9. Change in CD4 count

    Time frame: baseline, 4 months, 8 months, 12 months

    We want to see wither stigma reduction from the intervention associated with improved physical health bio-markers such as CD4+ T cell count.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Northwestern University
  • University of Alabama at Birmingham

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 8, 2013
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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