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

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ClinicalTrials.gov Identifier: NCT03898063
Recruitment Status : Completed
First Posted : April 1, 2019
Results First Posted : July 2, 2021
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
University of Miami CTSI
Information provided by (Responsible Party):
Nicholas Carcioppolo, University of Miami

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: 90 DAYS film Behavioral: HIV pamphlet on disclosure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 17, 2019
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Control
participants will receive a standard-of-care brochure detailing HIV status disclosure.
Behavioral: HIV pamphlet on disclosure
A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure

Experimental: intervention: 90 DAYS film
participants will watch the film, 90 DAYS
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.




Primary Outcome Measures :
  1. HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire [ Time Frame: Day 1 post test ]
    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.

  2. HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale [ Time Frame: Day 1 post-test ]
    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.

  3. Medical Adherence Intentions as Measured by the Medical Adherence Scale [ Time Frame: Day 1 post-test ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898063


Locations
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United States, Florida
University of Miami Medical Campus
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
University of Miami CTSI
Investigators
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Principal Investigator: Nicholas Carcioppolo, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Nicholas Carcioppolo, University of Miami:
Study Protocol  [PDF] April 1, 2020
Statistical Analysis Plan  [PDF] February 15, 2021

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Responsible Party: Nicholas Carcioppolo, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03898063    
Other Study ID Numbers: 20170967
CTSI-Pilot-FY19-01 ( Other Grant/Funding Number: University of Miami CTSI )
First Posted: April 1, 2019    Key Record Dates
Results First Posted: July 2, 2021
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases