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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

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 1, 2019
Results First Submitted Date  ICMJE May 17, 2021
Results First Posted Date  ICMJE July 2, 2021
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE June 17, 2019
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Number of participants self-reporting HIV Status Disclosure [ Time Frame: Week 4 ]
    Self-report measure of whether participants told a sexual partner they are HIV positive (if applicable to their situation). Data obtained through follow-up survey administered by research team. Quantified in the manuscript as a dichotomous variable (0 = not disclosed; 1 = disclosed). Only counted among the subset of the participants who have a romantic partner that they have not yet disclosed their status to.
  • HIV self-stigmatization as assessed via Stigmatization Questionnaire [ Time Frame: 4 weeks post-intervention ]
    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 stigmatization.
  • Participants' self-report estimates of their medical adherence as assessed through adherence questionnaires. [ Time Frame: Week 4 ]
    Self-report measure of perceptions of with medical recommendation adherence in the past 30 days. Assessed with three items asking participants to rate their ability to take their HIV medication over the past four weeks and their perceptions on whether they took their HIV medicine as prescribed in the past month (all items measured on a 6-pt scale where higher scores indicate better perceived medical adherence).
  • Participants' self-report estimates of their medical adherence as assessed through adherence questionnaires. [ Time Frame: Week 4 ]
    Self-report measure of the number of days participants were non-adherent with medical recommendations in the past 30 days. Assessed with one item asking participants the number of days (ranging from 0-30) they missed a dose of their HIV medicine in the past month with higher scores indicating increased nonadherence;
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • 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.
  • Behavioral: HIV pamphlet on disclosure
    A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure
Study Arms  ICMJE
  • Active Comparator: Control
    participants will receive a standard-of-care brochure detailing HIV status disclosure.
    Intervention: Behavioral: HIV pamphlet on disclosure
  • Experimental: intervention: 90 DAYS film
    participants will watch the film, 90 DAYS
    Intervention: Behavioral: 90 DAYS film
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2021)
148
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
500
Actual Study Completion Date  ICMJE May 31, 2020
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898063
Other Study ID Numbers  ICMJE 20170967
CTSI-Pilot-FY19-01 ( Other Grant/Funding Number: University of Miami CTSI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicholas Carcioppolo, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE University of Miami CTSI
Investigators  ICMJE
Principal Investigator: Nicholas Carcioppolo, PhD University of Miami
PRS Account University of Miami
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP