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Reducing HIV Stigma for African American Women

3. maj 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama Birmingham
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University (NU)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Adfærdsmæssigt: 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).
Andet: 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.
Adfærdsmæssigt: Breast Cancer Screening

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in stigma scores from baseline to 12 months.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Location as a moderator variable
Tidsramme: 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
Tidsramme: baseline, 12 months
baseline, 12 months
Adherence to HIV Medication
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Study duration
We are going to use a validated social support scale, and analyze social support as a correlate.
Study duration
substance abuse
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Deepa Rao, PhD, MA, University of Washington

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2013

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Faktiske)

1. februar 2017

Datoer for studieregistrering

Først indsendt

11. februar 2013

Først indsendt, der opfyldte QC-kriterier

1. juli 2013

Først opslået (Skøn)

8. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV

Kliniske forsøg med Unity Workshop

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner