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

NCT ID: NCT03898063

Last Updated: 2021-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

HIV pamphlet on disclosure

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

90 DAYS film

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

HIV pamphlet on disclosure

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Carcioppolo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicholas Carcioppolo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Medical Campus

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Qualtrics Recruitment ICF

View Document

Other Identifiers

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CTSI-Pilot-FY19-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20170967

Identifier Type: -

Identifier Source: org_study_id

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