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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03898063
Other study ID # 20170967
Secondary ID CTSI-Pilot-FY19-
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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