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

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

Feasibility of a Stigma Reduction Intervention for HIV-infected Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385241
• Other study ID #: Pro00028044
• Secondary ID: 1R21NR012415-01A
• Status: Completed
• Phase: N/A
• First received: June 14, 2011
• Last updated: October 20, 2014
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes
• Self-efficacy
• Self-esteem

Intervention

Behavioral:
• Ipod video
This group will be asked to watch the video on their Ipod Touch in its entirety at least once per week during the first four weeks of the study, and as often as desired in weeks 5-12. The participants will be asked to record the times viewed and their feelings/comments in a viewing log, and will be given surveys at 30 and 90 days.

Locations

Country	Name	City	State
United States	Duke University clinics	Henderson	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementing a stigma reduction intervention among Human Immunodeficiency Virus (HIV)-infected women	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.	90 days	No
Secondary	Acceptability of the use of a portable device to deliver a video intervention among Human Immunodeficiency Virus(HIV)-infected women	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.	90 days	No
Secondary	Utility of the use of a portable media device to deliver stigma-reduction intervention among Human Immunodeficiency Virus(HIV)-infected women	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.	90 days	No
Secondary	Change from baseline in levels of internalized stigma	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.	90 days	No
Secondary	Change from baseline in levels of coping self-efficacy	We will test whether this study increases the coping skills and belief in ability to cope in the women who receive it.	30 days, 90 days	No
Secondary	Change in safe disclosure behaviors from baseline	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.	90 days	No