Overview

This trial is active, not recruiting.

Condition hiv
Treatments unity workshop, breast cancer screening
Sponsor University of Washington
Collaborator University of Alabama at Birmingham
Start date June 2013
End date December 2016
Trial size 224 participants
Trial identifier NCT01893112, R01MH098675

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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
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).
(Other)
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.
breast cancer screening

Primary Outcomes

Measure
Change in stigma scores from baseline to 12 months.
time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months

Secondary Outcomes

Measure
Location as a moderator 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
time frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Patient Health Questionnaire (PHQ-9)
time frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Medical Outcomes Study Social Support Scale
time frame: Study duration
substance abuse
time frame: baseline, 12 months
Engagement in Care (from patient record)
time frame: baseline, 4 months, 8 months, 12 months
HIV viral load (from medical chart) over 1 year study duration
time frame: baseline, 4 months, 8 months, 12 months
Change in CD4 count
time frame: baseline, 4 months, 8 months, 12 months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Reducing HIV Stigma to Improve Health Outcomes for African-American Women
Principal investigator Deepa Rao, PhD, MA
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Washington.