Reducing HIV Stigma for African American Women

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893112
• Other study ID #: 43970
• Secondary ID: R01MH098675
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: May 3, 2017
• Start date: June 2013
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Northwestern University (NU)	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), Northwestern University, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (9)

CDC. HIV/AIDS Surveillance Report: Cases of HIV infection and AIDS in the United States. 2004.

CDC. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. Leading Cause of Death for Black Women 1999-2007. 2008; www.cdc.gov/ncipc/wisqars. Accessed December 4, 2011.

Halkitis PN, Parsons JT, Wolitski RJ, Remien RH. Characteristics of HIV antiretroviral treatments, access and adherence in an ethnically diverse sample of men who have sex with men. AIDS Care. 2003 Feb;15(1):89-102. — View Citation

Palacio H, Kahn JG, Richards TA, Morin SF. Effect of race and/or ethnicity in use of antiretrovirals and prophylaxis for opportunistic infection: a review of the literature. Public Health Rep. 2002 May-Jun;117(3):233-51; discussion 231-2. Review. — View Citation

Rao D, Desmond M, Andrasik M, Rasberry T, Lambert N, Cohn SE, Simoni J. Feasibility, acceptability, and preliminary efficacy of the unity workshop: an internalized stigma reduction intervention for African American women living with HIV. AIDS Patient Care STDS. 2012 Oct;26(10):614-20. doi: 10.1089/apc.2012.0106. Epub 2012 Sep 17. — View Citation

Rao D, Feldman BJ, Fredericksen RJ, Crane PK, Simoni JM, Kitahata MM, Crane HM. A structural equation model of HIV-related stigma, depressive symptoms, and medication adherence. AIDS Behav. 2012 Apr;16(3):711-6. doi: 10.1007/s10461-011-9915-0. — View Citation

Rao D, Kekwaletswe TC, Hosek S, Martinez J, Rodriguez F. Stigma and social barriers to medication adherence with urban youth living with HIV. AIDS Care. 2007 Jan;19(1):28-33. — View Citation

Rintamaki LS, Davis TC, Skripkauskas S, Bennett CL, Wolf MS. Social stigma concerns and HIV medication adherence. AIDS Patient Care STDS. 2006 May;20(5):359-68. — View Citation

Traeger L, O'Cleirigh C, Skeer MR, Mayer KH, Safren SA. Risk factors for missed HIV primary care visits among men who have sex with men. J Behav Med. 2012 Oct;35(5):548-56. doi: 10.1007/s10865-011-9383-z. Epub 2011 Nov 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Secondary	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	baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Secondary	Post-Traumatic Stress Disorder Checklist		baseline, 12 months
Secondary	Adherence to HIV Medication	Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.	baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Secondary	Patient Health Questionnaire (PHQ-9)	We will look at the correlation between stigma scores and depression scores over time.	baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Secondary	Medical Outcomes Study Social Support Scale	We are going to use a validated social support scale, and analyze social support as a correlate.	Study duration
Secondary	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)	baseline, 12 months
Secondary	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.	baseline, 4 months, 8 months, 12 months
Secondary	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).	baseline, 4 months, 8 months, 12 months
Secondary	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.	baseline, 4 months, 8 months, 12 months