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

NCT03898063 | Completed Results

• 2 other identifiers: 20170967CTSI-Pilot-FY19-01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (3)

• HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire

  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.

  Day 1 post test

• HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale

  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.

  Day 1 post-test

• Medical Adherence Intentions as Measured by the Medical Adherence Scale

  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.

  Day 1 post-test

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: HIV pamphlet on disclosure

intervention: 90 DAYS film

EXPERIMENTAL

participants will watch the film, 90 DAYS

Behavioral: 90 DAYS film

Interventions

90 DAYS film BEHAVIORAL

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.

intervention: 90 DAYS film

HIV pamphlet on disclosure BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Medical Campus

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Nick Carcioppolo
• Organization: University of Miami

n.carcioppolo@miami.edu

3052845633

Study Officials

• Nicholas Carcioppolo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: June 17, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)