HIVNCT01893112
Reducing HIV Stigma for African American Women
A study testing Unity Workshop and Breast Cancer Screening in people with HIV, run by University of Washington at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Unity Workshop and Breast Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Northwestern University (NU)
Chicago, Illinois, 60611
About this study
Official title: 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.
Read more
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.
- Conditions
- HIV
- Being tested
- Unity Workshop, Breast Cancer Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unity WorkshopBehavioural
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 ScreeningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Breast Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Secondary outcomes (9)
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
Measured: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Post-Traumatic Stress Disorder Checklist
Measured: baseline, 12 months
Adherence to HIV Medication
Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.
Measured: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Patient Health Questionnaire (PHQ-9)
We will look at the correlation between stigma scores and depression scores over time.
Measured: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Medical Outcomes Study Social Support Scale
We are going to use a validated social support scale, and analyze social support as a correlate.
Measured: Study duration
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)
Measured: baseline, 12 months
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.
Measured: baseline, 4 months, 8 months, 12 months
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).
Measured: baseline, 4 months, 8 months, 12 months
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.
Measured: baseline, 4 months, 8 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Northwestern University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Deepa Rao, University of Washington
- Investigators
- Deepa Rao, PhD, MA, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893112
- Sponsor's protocol ID
- 43970
- Other IDs
- R01MH098675
- Status last verified
- May 2017
- First submitted
- 11 Feb 2013
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12655837Palacio 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.
PubMed 12432135Traeger 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.
PubMed 22068878Rao 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.
PubMed 17129855Rintamaki 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.
PubMed 16706710Rao 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.
PubMed 21380495Rao 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.
PubMed 22984780
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Stigma to Improve Health Outcomes for African-American Women
- ClinicalTrials.gov ID
- NCT01893112
- Acronym / sponsor ID
- 43970
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Northwestern University, National Institute of Mental Health (NIMH)
- Study start
- Jun 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unity Workshop | Experimental | Behavioral: Unity WorkshopThe 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 |
| Breast Cancer Screening | Other | Behavioral: Breast Cancer ScreeningThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unity WorkshopThe 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). | Behavioural | Unity Workshop |
| Breast Cancer Screening | Behavioural | Breast Cancer Screening |
Primary outcome
Change in stigma scores from baseline to 12 months.
Time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 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.
9 secondary outcomes
Location as a moderator variable
Time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Post-Traumatic Stress Disorder Checklist
Time frame: baseline, 12 months
Adherence to HIV Medication
Time frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Patient Health Questionnaire (PHQ-9)
Time frame: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Medical Outcomes Study Social Support Scale
Time frame: Study duration
substance abuse
Time frame: baseline, 12 months
Engagement in Care (from patient record)
Time frame: baseline, 4 months, 8 months, 12 months
HIV viral load (from medical chart) over 1 year study duration
Time frame: baseline, 4 months, 8 months, 12 months
Change in CD4 count
Time frame: baseline, 4 months, 8 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- BackgroundCDC. HIV/AIDS Surveillance Report: Cases of HIV infection and AIDS in the United States. 2004.
- BackgroundCDC. 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: PubMed 12655837Halkitis 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.
- Background: PubMed 12432135Palacio 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.
- Background: PubMed 22068878Traeger 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.
- Background: PubMed 17129855Rao 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.
- Background: PubMed 16706710Rintamaki 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.
- Background: PubMed 21380495Rao 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.
- Background: PubMed 22984780Rao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Rao, PhD, MA principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unity Workshop and Breast Cancer Screening in people with HIV, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stigma scores from baseline to 12 months. (time frame: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893112, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.