Clinical trial NCT01893112: Reducing HIV Stigma for African American Women
Official title: Reducing HIV Stigma to Improve Health Outcomes for African-American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Northwestern University
name: National Institute of Mental Health (NIMH)
First posted: 2013-07-08
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in stigma scores from baseline to 12 months.
timeFrame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Secondary outcomes:
measure: Location as a moderator variable
timeFrame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
measure: Post-Traumatic Stress Disorder Checklist
timeFrame: baseline, 12 months
measure: Adherence to HIV Medication
timeFrame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
measure: Medical Outcomes Study Social Support Scale
timeFrame: Study duration
measure: substance abuse
timeFrame: baseline, 12 months
measure: Engagement in Care (from patient record)
timeFrame: baseline, 4 months, 8 months, 12 months
measure: HIV viral load (from medical chart) over 1 year study duration
timeFrame: baseline, 4 months, 8 months, 12 months
measure: Change in CD4 count
timeFrame: baseline, 4 months, 8 months, 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University (NU)
state: Illinois
Study officials:
affiliation: University of Washington
name: Deepa Rao, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: CDC. HIV/AIDS Surveillance Report: Cases of HIV infection and AIDS in the United States. 2004.
citation: 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.
citation: 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.
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. doi: 10.1093/phr/117.3.233.
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.
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. doi: 10.1080/09540120600652303.
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. doi: 10.1089/apc.2006.20.359.
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.
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.