Trial Outcomes & Findings for 90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure (NCT NCT03898063)
NCT ID: NCT03898063
Last Updated: 2021-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
Day 1 post test
Results posted on
2021-07-02
Participant Flow
Participant milestones
| Measure |
Control
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
|
Intervention: 90 DAYS Film
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.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
64
|
66
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Control
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
|
Intervention: 90 DAYS Film
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
Baseline Characteristics
90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
Baseline characteristics by cohort
| Measure |
Control
n=74 Participants
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
|
Intervention: 90 DAYS Film
n=74 Participants
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
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.64 years
STANDARD_DEVIATION 6.65 • n=93 Participants
|
32.64 years
STANDARD_DEVIATION 7.73 • n=4 Participants
|
32.15 years
STANDARD_DEVIATION 7.21 • n=27 Participants
|
|
Sex/Gender, Customized
sex · female
|
64 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Sex/Gender, Customized
sex · male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex/Gender, Customized
sex · not reported
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 post testself-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.
Outcome measures
| Measure |
Control
n=64 Participants
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).
|
Treatment
n=66 Participants
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).
|
|---|---|---|
|
HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
|
2.93 score on a scale
Standard Deviation 1.07
|
2.95 score on a scale
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Day 1 post-testSelf-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.
Outcome measures
| Measure |
Control
n=64 Participants
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).
|
Treatment
n=66 Participants
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).
|
|---|---|---|
|
HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale
|
4.19 score on a scale
Standard Deviation 0.82
|
4.45 score on a scale
Standard Deviation 0.66
|
PRIMARY outcome
Timeframe: Day 1 post-testSelf-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.
Outcome measures
| Measure |
Control
n=64 Participants
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).
|
Treatment
n=66 Participants
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).
|
|---|---|---|
|
Medical Adherence Intentions as Measured by the Medical Adherence Scale
|
2.56 score on a scale
Standard Deviation 1.43
|
2.53 score on a scale
Standard Deviation 1.42
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention: 90 DAYS Film
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place