Back to results90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
90 DAYS film
HIV pamphlet on disclosure
Sponsored by
About this trial
This is an interventional supportive care trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- Black women ages 18-50
- clinically diagnosed with HIV/AIDS
- Speak and comprehend English
Exclusion Criteria:
- pregnant women
Sites / Locations
- University of Miami Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
intervention: 90 DAYS film
Arm Description
participants will receive a standard-of-care brochure detailing HIV status disclosure.
participants will watch the film, 90 DAYS
Outcomes
Primary Outcome Measures
HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
self-report measure of the extent to which participants stigmatize themselves for being HIV positive. Quantified in the manuscript using the mean of the self-report scale. Scores range from 1-5 with higher scores indicating higher perceptions of self-stigmatization.
HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale
Self-report measure of the extent to which participants intend to disclose their HIV status to a partner. Quantified in the manuscript using the mean of the self-report scale. Scores range from 1-5 with higher scores indicating higher intentions of status disclosure.
Medical Adherence Intentions as Measured by the Medical Adherence Scale
Self-report measure of participants likeliness to miss doses of their antiretroviral medication over a 30 day period. Quantified in the manuscript using the mean of the self-report scale. Scores range from 1-5 with higher scores indicating increased likeliness to miss doses of antiretroviral medication.
Secondary Outcome Measures
Full Information
NCT ID
NCT03898063
First Posted
March 29, 2019
Last Updated
June 11, 2021
Sponsor
University of Miami
Collaborators
University of Miami CTSI
1. Study Identification
Unique Protocol Identification Number
NCT03898063
Brief Title
90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
Official Title
An Experimental Investigation of the Effects of an Entertainment Education Short Film on Internalized HIV-related Stigma, Sexual Partner Status Disclosure, and Medical Adherence Intentions Among Black HIV-positive Women in Miami-Dade County
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
University of Miami CTSI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This investigation seeks to understand if and how, the 90 Days film can be used as an intervention to address HIV-related stigmas, intimate partner status disclosure and HIV ART medical adherence among Black HIV positive women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
participants will receive a standard-of-care brochure detailing HIV status disclosure.
Arm Title
intervention: 90 DAYS film
Arm Type
Experimental
Arm Description
participants will watch the film, 90 DAYS
Intervention Type
Behavioral
Intervention Name(s)
90 DAYS film
Intervention Description
the intervention conditions include exposure to a film, 90 DAYS (approx 20 minutes long), an entertainment film detailing a woman's decision to tell her romantic partner that she is HIV-positive.
Intervention Type
Behavioral
Intervention Name(s)
HIV pamphlet on disclosure
Intervention Description
A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure
Primary Outcome Measure Information:
Title
HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
Description
self-report measure of the extent to which participants stigmatize themselves for being HIV positive. Quantified in the manuscript using the mean of the self-report scale. Scores range from 1-5 with higher scores indicating higher perceptions of self-stigmatization.
Time Frame
Day 1 post test
Title
HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale
Description
Self-report measure of the extent to which participants intend to disclose their HIV status to a partner. Quantified in the manuscript using the mean of the self-report scale. Scores range from 1-5 with higher scores indicating higher intentions of status disclosure.
Time Frame
Day 1 post-test
Title
Medical Adherence Intentions as Measured by the Medical Adherence Scale
Description
Self-report measure of participants likeliness to miss doses of their antiretroviral medication over a 30 day period. Quantified in the manuscript using the mean of the self-report scale. Scores range from 1-5 with higher scores indicating increased likeliness to miss doses of antiretroviral medication.
Time Frame
Day 1 post-test
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Black women ages 18-50
clinically diagnosed with HIV/AIDS
Speak and comprehend English
Exclusion Criteria:
pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Carcioppolo, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Medical Campus
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
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