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| ID | Type | Description | Link |
|---|---|---|---|
| CTSI-Pilot-FY19-01 | Other Grant/Funding Number | University of Miami CTSI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | participants will receive a standard-of-care brochure detailing HIV status disclosure. |
|
| intervention: 90 DAYS film | Experimental | participants will watch the film, 90 DAYS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Carcioppolo, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Medical Campus | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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 |
| FG001 | Intervention: 90 DAYS Film | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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 |
| BG001 | Intervention: 90 DAYS Film |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 post test |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Carcioppolo | University of Miami | 3052845633 | n.carcioppolo@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2020 | May 4, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2021 | Mar 1, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Qualtrics Recruitment ICF | Apr 1, 2020 | May 4, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| HIV pamphlet on disclosure | Behavioral | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 post-test |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 post-test |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intervention: 90 DAYS Film | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |