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Human Immunodeficiency Virus (HIV)NCT01385241

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

A study testing Ipod video in people with Human Immunodeficiency Virus (HIV) and Self-efficacy, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ipod video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteUnited States
Study dates
Jul 2011to Jan 2014
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

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University clinics

    Henderson, North Carolina, 27710

Other trials in United States

About this study

Official title: Feasibility of a Stigma Reduction Intervention for HIV-infected Women

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.

Read the 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.

Being tested
Ipod video
Keywords
Human Immunodeficiency Virus (HIV), Stigma, Safe disclosure of seropositive status, HIV positive women, Self-efficacy
Medical subject headings
Acquired Immunodeficiency Syndrome, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ipod videoBehavioural

    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.

Study groups in NCT01385241
Study groupRoleWhat they receive
Received video interventionExperimentalThe 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.
Receives: Behavioral: Ipod video
Did not receive videoNo interventionThis group does not receive the video intervention during the study period, and will complete surveys at baseline, 30 days and 90 days for comparison to the intervention group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90 days

Secondary outcomes (5)
  1. 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.

    Measured: 90 days

  2. 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.

    Measured: 90 days

  3. 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.

    Measured: 90 days

  4. 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.

    Measured: 30 days, 90 days

  5. 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.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

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
Single blind
Who is masked
Participant
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01385241
Sponsor's protocol ID
Pro00028044
Other IDs
1R21NR012415-01A1
Status last verified
Oct 2014
First submitted
14 Jun 2011
Last updated
22 Oct 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Ipod video in people with Human Immunodeficiency Virus (HIV) and Self-efficacy, run by Duke University at 1 site 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 4 inclusion and 0 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 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Feasibility of implementing a stigma reduction intervention among Human Immunodeficiency Virus (HIV)-infected women (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Oct 2014.

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