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

20 ottobre 2014 aggiornato da: Duke University

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

99

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • North Carolina
      • Henderson, North Carolina, Stati Uniti, 27710
        • Duke University clinics

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of implementing a stigma reduction intervention among Human Immunodeficiency Virus (HIV)-infected women
Lasso di tempo: 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.
90 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of the use of a portable device to deliver a video intervention among Human Immunodeficiency Virus(HIV)-infected women
Lasso di tempo: 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.
90 days
Utility of the use of a portable media device to deliver stigma-reduction intervention among Human Immunodeficiency Virus(HIV)-infected women
Lasso di tempo: 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.
90 days
Change from baseline in levels of internalized stigma
Lasso di tempo: 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.
90 days
Change from baseline in levels of coping self-efficacy
Lasso di tempo: 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.
30 days, 90 days
Change in safe disclosure behaviors from baseline
Lasso di tempo: 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.
90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Julie Barroso, PhD, Duke University School of Nursing

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2011

Completamento primario (Effettivo)

1 gennaio 2014

Completamento dello studio (Effettivo)

1 gennaio 2014

Date di iscrizione allo studio

Primo inviato

14 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2011

Primo Inserito (Stima)

30 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

22 ottobre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 ottobre 2014

Ultimo verificato

1 ottobre 2014

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Virus dell'immunodeficienza umana (HIV)

Prove cliniche su Ipod video

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