Reducing HIV Stigma for African American Women
3 de maio de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
240
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama Birmingham
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University (NU)
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in stigma scores from baseline to 12 months.
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Location as a moderator variable
Prazo: 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
Prazo: baseline, 12 months
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baseline, 12 months
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Adherence to HIV Medication
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Deepa Rao, PhD, MA, University of Washington
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2013
Conclusão Primária (Real)
1 de novembro de 2016
Conclusão do estudo (Real)
1 de fevereiro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
11 de fevereiro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de julho de 2013
Primeira postagem (Estimativa)
8 de julho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 43970
- R01MH098675 (Concessão/Contrato do NIH dos EUA)
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