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Reducing HIV Stigma for African American Women

3 maj 2017 uppdaterad av: 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:

  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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

240

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • University of Alabama Birmingham
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University (NU)

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Beteende: Unity Workshop
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).
Övrig: 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.
Beteende: Breast Cancer Screening

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in stigma scores from baseline to 12 months.
Tidsram: 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.
baseline, after intervervention, 4 months, 6 months, 8 months, 12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Location as a moderator variable
Tidsram: baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
This is a multi-site study (Chicago and Birmingham) and we are interested in seeing if location is a moderating variable
baseline, after intervervention, 4 months, 6 months, 8 months, 12 months
Post-Traumatic Stress Disorder Checklist
Tidsram: baseline, 12 months
baseline, 12 months
Adherence to HIV Medication
Tidsram: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Adherence to HIV medication will be measured by participants self report of adherence using commonly used set of questions.
baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Patient Health Questionnaire (PHQ-9)
Tidsram: baseline, after intervention, 4 months, 6 months, 8 months, 12 months
We will look at the correlation between stigma scores and depression scores over time.
baseline, after intervention, 4 months, 6 months, 8 months, 12 months
Medical Outcomes Study Social Support Scale
Tidsram: Study duration
We are going to use a validated social support scale, and analyze social support as a correlate.
Study duration
substance abuse
Tidsram: baseline, 12 months
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)
baseline, 12 months
Engagement in Care (from patient record)
Tidsram: baseline, 4 months, 8 months, 12 months
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.
baseline, 4 months, 8 months, 12 months
HIV viral load (from medical chart) over 1 year study duration
Tidsram: baseline, 4 months, 8 months, 12 months
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).
baseline, 4 months, 8 months, 12 months
Change in CD4 count
Tidsram: baseline, 4 months, 8 months, 12 months
We want to see wither stigma reduction from the intervention associated with improved physical health bio-markers such as CD4+ T cell count.
baseline, 4 months, 8 months, 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Samarbetspartners

National Institute of Mental Health (NIMH)
Northwestern University
University of Alabama at Birmingham

Utredare

  • Huvudutredare: Deepa Rao, PhD, MA, University of Washington

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2013

Primärt slutförande (Faktisk)

1 november 2016

Avslutad studie (Faktisk)

1 februari 2017

Studieregistreringsdatum

Först inskickad

11 februari 2013

Först inskickad som uppfyllde QC-kriterierna

1 juli 2013

Första postat (Uppskatta)

8 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 maj 2017

Senast verifierad

1 maj 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 43970
  • R01MH098675 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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