Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898063
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
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: Film epilogue Behavioral: HIV pamphlet on disclosure Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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 1: 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.

Experimental: intervention 2: 90 DAYS film plus epilogue
participants will watch the film, 90 DAYS and also a brief epilogue created by the research team that connects key messages in the narrative and steps to enact safe disclosure
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: Film epilogue
a 90-second epilogue developed by the research team making tangible connections between the film and one's own potential HIV status disclosure. Highlights safe strategies for disclosure.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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;

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Black women ages 18-35
  • 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


Contacts
Layout table for location contacts
Contact: Nicholas Carcioppolo, PhD 3052855633 n.carcioppolo@miami.edu

Locations
Layout table for location information
United States, Florida
University of Miami Medical Campus Recruiting
Miami, Florida, United States, 33136
Contact: Nicholas Carcioppolo, PhD    305-284-5633    n.carcioppolo@Miami.edu   
Sponsors and Collaborators
University of Miami
National Center for Advancing Translational Science (NCATS)
Investigators
Layout table for investigator information
Principal Investigator: Nicholas Carcioppolo, PhD University of Miami

Layout table for additonal information
Responsible Party: Nicholas Carcioppolo, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03898063     History of Changes
Other Study ID Numbers: 20170967
UL1TR002736 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No