Reducing HIV Stigma for African American Women

NCT01893112 | Completed DMC

• 2 other identifiers: 43970R01MH098675
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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. 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. 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. 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

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Location as a moderator variable

  baseline, after intervervention, 4 months, 6 months, 8 months, 12 months

• 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

• Medical Outcomes Study Social Support Scale

  Study duration

Study Arms (2)

Unity Workshop

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

Behavioral: Unity Workshop

Breast Cancer Screening

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.

Behavioral: Breast Cancer Screening

Interventions

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).

Unity Workshop

Breast Cancer Screening BEHAVIORAL

Breast Cancer Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• University of Alabama at Birmingham: collaborator
• Northwestern University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Northwestern University (NU)

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

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

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1080/095401221000039798.

  PMID: 12655837 BACKGROUND

• 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. doi: 10.1093/phr/117.3.233.

  PMID: 12432135 BACKGROUND

• 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.

  PMID: 22068878 BACKGROUND

• 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. doi: 10.1080/09540120600652303.

  PMID: 17129855 BACKGROUND

• 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. doi: 10.1089/apc.2006.20.359.

  PMID: 16706710 BACKGROUND

• 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.

  PMID: 21380495 BACKGROUND

• 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.

  PMID: 22984780 BACKGROUND

Study Officials

• Deepa Rao, PhD, MA

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Global Health

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: July 8, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (2)