HIV/AIDSNCT03898063
90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
A study testing 90 DAYS film and HIV pamphlet on disclosure in people with HIV/AIDS, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- 90 DAYS film and HIV pamphlet on disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Black women ages 18-50
- clinically diagnosed with HIV/AIDS
- Speak and comprehend English
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Medical Campus
Miami, Florida, 33136
About this study
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
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
- Being tested
- 90 DAYS film, HIV pamphlet on disclosure
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 DAYS filmBehavioural
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.
HIV pamphlet on disclosureBehavioural
A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | participants will receive a standard-of-care brochure detailing HIV status disclosure. Receives: Behavioral: HIV pamphlet on disclosure |
| intervention: 90 DAYS film | Experimental | participants will watch the film, 90 DAYS Receives: Behavioral: 90 DAYS film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start17 Jun 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Carcioppolo, University of Miami
- Investigators
- Nicholas Carcioppolo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898063
- Sponsor's protocol ID
- 20170967
- Other IDs
- CTSI-Pilot-FY19-01
- Status last verified
- Jun 2021
- First submitted
- 29 Mar 2019
- Last updated
- 2 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03898063
- Acronym / sponsor ID
- 20170967
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: HIV pamphlet on disclosureparticipants will receive a standard-of-care brochure detailing HIV status disclosure. |
| intervention: 90 DAYS film | Experimental | Behavioral: 90 DAYS filmparticipants will watch the film, 90 DAYS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Black women ages 18-50
- clinically diagnosed with HIV/AIDS
- Speak and comprehend English
Key exclusion criteria (1 listed)
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 90 DAYS filmthe 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. | Behavioural | intervention: 90 DAYS film |
| HIV pamphlet on disclosureA standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure | Behavioural | Control |
Primary outcome
HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
Time frame: 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.
HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale
Time frame: 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.
Medical Adherence Intentions as Measured by the Medical Adherence Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Carcioppolo, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 90 DAYS film and HIV pamphlet on disclosure in people with HIV/AIDS, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire (time frame: Day 1 post test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.