NCT01385241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

2.5 years

First QC Date

June 14, 2011

Last Update Submit

October 20, 2014

Conditions

Human Immunodeficiency Virus (HIV)Self-efficacySelf-esteem

Keywords

Human Immunodeficiency Virus (HIV)StigmaSafe disclosure of seropositive statusHIV positive womenSelf-efficacy

Outcome Measures

Primary Outcomes (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.

    90 days

Secondary Outcomes (5)

  • Acceptability of the use of a portable device to deliver a video intervention among Human Immunodeficiency Virus(HIV)-infected women

    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

  • Change from baseline in levels of internalized stigma

    90 days

  • Change from baseline in levels of coping self-efficacy

    30 days, 90 days

  • Change in safe disclosure behaviors from baseline

    90 days

Study Arms (2)

Received video intervention

EXPERIMENTAL

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.

Behavioral: Ipod video

Did not receive video

NO INTERVENTION

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.

Interventions

Ipod videoBEHAVIORAL

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.

Received video intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University clinics

Henderson, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSocial Stigma

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Study Officials

  • Julie Barroso, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 30, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations

US(1)