NCT03898063

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

Completed NA Results posted Last updated 2 July 2021

What this trial tests

NA trial testing 90 DAYS film in HIV/AIDS in 148 participants. Completed in 31 May 2020.

Timeline

17 June 2019

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	148
Start date	17 June 2019
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across United States

Drugs / interventions tested

• 90 DAYS film
• HIV pamphlet on disclosure

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

University of Miami

Who can join

Adults 18 to 50, female only, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire Primary · 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.

Group	Value	95% CI
Control	2.93	± 1.07
Treatment	2.95	± 1.14

HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale Primary · 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.

Group	Value	95% CI
Control	4.19	± 0.82
Treatment	4.45	± 0.66

Medical Adherence Intentions as Measured by the Medical Adherence Scale Primary · 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.

Group	Value	95% CI
Control	2.56	± 1.43
Treatment	2.53	± 1.42

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.