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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03898063
• Collaborator: University of Miami CTSI (Other)
• Enrollment: 148
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 12.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 17, 2019
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Black women ages 18-50

• clinically diagnosed with HIV/AIDS

• Speak and comprehend English

Exclusion Criteria:

• pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Medical Campus	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• University of Miami CTSI

Investigators

• Principal Investigator: Nicholas Carcioppolo, PhD, University of Miami

Study Documents (Full-Text)

• Study Protocol - Apr 1, 2020
• Statistical Analysis Plan - Feb 15, 2021
• Informed Consent Form: Qualtrics Recruitment ICF - Apr 1, 2020

More Information

Publications

None provided.

• Responsible Party: Nicholas Carcioppolo, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03898063
• Other Study ID Numbers: 20170967; CTSI-Pilot-FY19-01
• First Posted: Apr 1, 2019
• Last Update Posted: Jul 2, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Arm/Group Title	Control	Intervention: 90 DAYS Film
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

Baseline Characteristics

Arm/Group Title	Control	Intervention: 90 DAYS Film	Total
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 Participants	74	74	148
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.64 (6.65)	32.64 (7.73)	32.15 (7.21)
Sex/Gender, Customized (Count of Participants)
female	64 86.5%	66 89.2%	130 87.8%
male	0 0%	0 0%	0 0%
not reported	10 13.5%	8 10.8%	18 12.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	74 100%	74 100%	148 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	10 13.5%	8 10.8%	18 12.2%

Outcome Measures

1. Primary Outcome

Title	HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Treatment
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).
Measure Participants	64	66
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Treatment
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).
Measure Participants	64	66
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Treatment
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).
Measure Participants	64	66
Mean (Standard Deviation) [score on a scale]	2.56 (1.43)	2.53 (1.42)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Control		Intervention: 90 DAYS Film
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Control		Intervention: 90 DAYS Film
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.