Reducing HIV Stigma for African American Women
3 mai 2017 mis à jour par: Deepa Rao, University of Washington
Reducing HIV Stigma to Improve Health Outcomes 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:
- 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
- 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
- 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
240
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama Birmingham
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University (NU)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Unity Workshop
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
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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).
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Autre: Breast Cancer Screening
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in stigma scores from baseline to 12 months.
Délai: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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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.
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baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Location as a moderator variable
Délai: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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This is a multi-site study (Chicago and Birmingham) and we are interested in seeing if location is a moderating variable
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baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
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Post-Traumatic Stress Disorder Checklist
Délai: baseline, 12 months
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baseline, 12 months
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Adherence to HIV Medication
Délai: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.
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baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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Patient Health Questionnaire (PHQ-9)
Délai: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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We will look at the correlation between stigma scores and depression scores over time.
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baseline, after intervention, 4 months, 6 months, 8 months, 12 months
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Medical Outcomes Study Social Support Scale
Délai: Study duration
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We are going to use a validated social support scale, and analyze social support as a correlate.
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Study duration
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substance abuse
Délai: baseline, 12 months
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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)
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baseline, 12 months
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Engagement in Care (from patient record)
Délai: baseline, 4 months, 8 months, 12 months
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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.
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baseline, 4 months, 8 months, 12 months
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HIV viral load (from medical chart) over 1 year study duration
Délai: baseline, 4 months, 8 months, 12 months
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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).
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baseline, 4 months, 8 months, 12 months
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Change in CD4 count
Délai: baseline, 4 months, 8 months, 12 months
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We want to see wither stigma reduction from the intervention associated with improved physical health bio-markers such as CD4+ T cell count.
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baseline, 4 months, 8 months, 12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Deepa Rao, PhD, MA, University of Washington
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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. doi: 10.1080/095401221000039798.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2013
Achèvement primaire (Réel)
1 novembre 2016
Achèvement de l'étude (Réel)
1 février 2017
Dates d'inscription aux études
Première soumission
11 février 2013
Première soumission répondant aux critères de contrôle qualité
1 juillet 2013
Première publication (Estimation)
8 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 mai 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mai 2017
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 43970
- R01MH098675 (Subvention/contrat des NIH des États-Unis)
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