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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition HIV/AIDS
Interventions Behavioral: 90 DAYS film
Behavioral: HIV pamphlet on disclosure
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Intervention: 90 DAYS Film
Hide Arm/Group Description

participants will receive a standard-of-care brochure detailing HIV status disclosure.

HIV pamphlet on disclosure: A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure

participants will watch the film, 90 DAYS

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.

Period Title: Overall Study
Started 74 74
Completed 64 66
Not Completed 10 8
Reason Not Completed
Withdrawal by Subject             10             8
Arm/Group Title Control Intervention: 90 DAYS Film Total
Hide Arm/Group Description

participants will receive a standard-of-care brochure detailing HIV status disclosure.

HIV pamphlet on disclosure: A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure

participants will watch the film, 90 DAYS

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.

Total of all reporting groups
Overall Number of Baseline Participants 74 74 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 148 participants
31.64  (6.65) 32.64  (7.73) 32.15  (7.21)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
sex Number Analyzed 74 participants 74 participants 148 participants
female
64
  86.5%
66
  89.2%
130
  87.8%
male
0
   0.0%
0
   0.0%
0
   0.0%
not reported
10
  13.5%
8
  10.8%
18
  12.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
74
 100.0%
74
 100.0%
148
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
64
  86.5%
66
  89.2%
130
  87.8%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
  13.5%
8
  10.8%
18
  12.2%
1.Primary Outcome
Title HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
Hide Description 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.
Time Frame Day 1 post test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Hide Arm/Group Description:
The participants in the control arm reviewed a brochure. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two arms: control (brochure) or treatment (90 DAYS narrative).
The participants in the treatment arm viewed the 90 DAYS entertainment education film. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two study arms: control (brochure) or treatment (90 DAYS film).
Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.93  (1.07) 2.95  (1.14)
2.Primary Outcome
Title HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale
Hide Description 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.
Time Frame Day 1 post-test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Hide Arm/Group Description:
The participants in the control arm reviewed a brochure. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two arms: control (brochure) or treatment (90 DAYS narrative).
The participants in the treatment arm viewed the 90 DAYS entertainment education film. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two study arms: control (brochure) or treatment (90 DAYS film).
Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.19  (0.82) 4.45  (0.66)
3.Primary Outcome
Title Medical Adherence Intentions as Measured by the Medical Adherence Scale
Hide Description 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.
Time Frame Day 1 post-test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Hide Arm/Group Description:
The participants in the control arm reviewed a brochure. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two arms: control (brochure) or treatment (90 DAYS narrative).
The participants in the treatment arm viewed the 90 DAYS entertainment education film. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two study arms: control (brochure) or treatment (90 DAYS film).
Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.56  (1.43) 2.53  (1.42)
Time Frame All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Adverse Event Reporting Description All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
 
Arm/Group Title Control Intervention: 90 DAYS Film
Hide Arm/Group Description

participants will receive a standard-of-care brochure detailing HIV status disclosure.

HIV pamphlet on disclosure: A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure

participants will watch the film, 90 DAYS

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.

All-Cause Mortality
Control Intervention: 90 DAYS Film
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Control Intervention: 90 DAYS Film
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Intervention: 90 DAYS Film
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nick Carcioppolo
Organization: University of Miami
Phone: 3052845633
EMail: n.carcioppolo@miami.edu
Layout table for additonal information
Responsible Party: Nicholas Carcioppolo, 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 Submitted: March 29, 2019
First Posted: April 1, 2019
Results First Submitted: May 17, 2021
Results First Posted: July 2, 2021
Last Update Posted: July 2, 2021