Feasibility of a Stigma Reduction Intervention for Human Immunodeficiency Virus (HIV)-Infected Women

Not Applicable

Completed

• Conditions: Self-esteem; Self-efficacy; Human Immunodeficiency Virus (HIV)
• Interventions: Behavioral: Ipod video

• Registration Number: NCT01385241
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to test the feasibility of a stigma reduction intervention in Human Immunodeficiency Virus(HIV)-positive women using a video of first-person narratives delivered via personal Ipod Touch.

Detailed Description

Nearly 30 years into the Acquired Immune Deficiency Syndrome (AIDS) epidemic, stigma is still hampering efforts to stop its spread. Human Immunodeficiency Virus(HIV)-infected women are particularly vulnerable to both perceived and enacted stigma, which together are referred to as internalized stigma. As the demographic face of HIV infection in the US has changed from being largely a disease of gay white men to one of poor minority women, the debilitating effects of stigma have worsened. It has a profound impact on prevention and treatment efforts; women with HIV infection may be fearful of insisting that their sexual partners wear condoms because of the possibility that this may signal their serostatus, and they may not want to take antiretroviral medications in front of others, fearing that people may ask questions about their pills and the reasons for taking them. The effects of stigma include a cascade of other negative outcomes as well, including poor self-esteem and self-efficacy, especially self-efficacy for disclosure and for coping. Yet it is nearly impossible to intervene with those who stigmatize others because this group is often as broad as the general public, and they may not be interested in an intervention. Therefore, the best approach may be to work with women who are experiencing stigma, in an effort to decrease stigma, improve self-esteem and coping self-efficacy, and facilitate safe disclosure. To date, there have been few interventions to help HIV-infected women deal with stigma. One option would be a video converted to an Moving Picture 4 (MP4) file that can be viewed on an iPod Touch, a small portable viewing device, allowing the woman privacy and safety in viewing. Barroso (primary investigator on the proposed study) assisted in the creation of a video on stigma for women with HIV infection, based on the results of a qualitative metasynthesis. The 45-minute video presents vignettes about five seropositive women and the ways in which stigma has impacted their lives. The primary aim of the proposed study is to assess the feasibility, acceptability and utility of implementing this low-cost, technologically delivered intervention to mitigate the negative effects of HIV-related stigma on seropositive women. The secondary aim is to compare outcomes across time in women who receive the stigma intervention with those of a control group receiving usual care at baseline, 30, and 90 days, and to determine effect sizes for a larger definitive study to test the efficacy of this intervention in reducing internalized stigma, improving coping self-efficacy and self-esteem, and facilitating safe disclosure in HIV-infected women. The investigators believe that this intervention is innovative because they are the first investigators to propose using a video, developed from the findings of a metasynthesis of studies about stigma as it is experienced by HIV-infected women, for this purpose. It is also innovative in the use of a portable viewing device which will allow the women to safely and privately view the video. The investigators further believe that this intervention has the potential to make a significant impact, at a low cost in terms of money and personnel time, in mitigating stigma.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• speaks, understands, and reads English
• Scores over 40 on Internalized Human Immunodeficiency Virus (HIV) Stigma Scale
• HIV positive
• mentally competent to give informed consent

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Received video intervention	Ipod video	The group of women who received an Ipod Touch with the video loaded onto it and told to view it at least once a week for the first 4 weeks, and as often as desired in weeks 5-12.

Primary Outcome Measures

Name	Time	Method
Feasibility of implementing a stigma reduction intervention among Human Immunodeficiency Virus (HIV)-infected women	90 days	We will test whether the use of an Ipod Touch video intervention is feasible in this study population by comparing baseline data with data collected at 30 days into the intervention and upon completion of the intervention at 90 days.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in levels of internalized stigma	90 days	We will test whether this intervention reduces the level of internalized stigma experienced by Human Immunodeficiency Virus(HIV)-positive women, comparing baseline levels with levels at 30 days and 90 days.
Utility of the use of a portable media device to deliver stigma-reduction intervention among Human Immunodeficiency Virus(HIV)-infected women	90 days	We will test whether the intervention method is useful to the study population in achieving the desired outcome by measuring feelings of stigma at baseline, 30 days and 90 days and assessing positive change.
Acceptability of the use of a portable device to deliver a video intervention among Human Immunodeficiency Virus(HIV)-infected women	90 days	We will test whether the means and the method employed to deliver this intervention are acceptable to the study population through the collection of qualitative data at 30 days and 90 days.
Change from baseline in levels of coping self-efficacy	30 days, 90 days	We will test whether this study increases the coping skills and belief in ability to cope in the women who receive it.
Change in safe disclosure behaviors from baseline	90 days	Though they were not expressly told to disclose their status as a part of this study, we would like to find out whether this video inspires women to disclose their status to family members, sexual partners, and other support people whom they deem to be safe and trustworthy confidantes.

Trial Locations

Locations (1)

Duke University clinics; 🇺🇸 Henderson, North Carolina, United States