90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898063
• Other study ID #: 20170967
• Secondary ID: CTSI-Pilot-FY19-
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Black women ages 18-50
• clinically diagnosed with HIV/AIDS
• Speak and comprehend English

Exclusion Criteria:

• pregnant women

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• 90 DAYS film
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.
• HIV pamphlet on disclosure
A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure

Locations

Country	Name	City	State
United States	University of Miami Medical Campus	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	University of Miami CTSI

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 post test
Primary	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.	Day 1 post-test
Primary	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.	Day 1 post-test