Feasibility of a Stigma Reduction Intervention for Human Immunodeficiency Virus (HIV)-Infected Women
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ClinicalTrials.gov Identifier: NCT01385241 |
Recruitment Status
:
Completed
First Posted
: June 30, 2011
Last Update Posted
: October 22, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus (HIV) Self-efficacy Self-esteem | Behavioral: Ipod video | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Feasibility of a Stigma Reduction Intervention for HIV-infected Women |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Received video intervention
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.
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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.
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No Intervention: Did not receive video
This 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.
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- Feasibility of implementing a stigma reduction intervention among Human Immunodeficiency Virus (HIV)-infected women [ Time Frame: 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.
- Acceptability of the use of a portable device to deliver a video intervention among Human Immunodeficiency Virus(HIV)-infected women [ Time Frame: 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.
- Utility of the use of a portable media device to deliver stigma-reduction intervention among Human Immunodeficiency Virus(HIV)-infected women [ Time Frame: 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.
- Change from baseline in levels of internalized stigma [ Time Frame: 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.
- Change from baseline in levels of coping self-efficacy [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385241
United States, North Carolina | |
Duke University clinics | |
Henderson, North Carolina, United States, 27710 |
Principal Investigator: | Julie Barroso, PhD | Duke University School of Nursing |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01385241 History of Changes |
Other Study ID Numbers: |
Pro00028044 1R21NR012415-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | June 30, 2011 Key Record Dates |
Last Update Posted: | October 22, 2014 |
Last Verified: | October 2014 |
Keywords provided by Duke University:
Human Immunodeficiency Virus (HIV) Stigma Safe disclosure of seropositive status HIV positive women Self-efficacy |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |