HIV/AIDS
Conditions
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.
Interventions
BEHAVIORAL90 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.
BEHAVIORALHIV pamphlet on disclosure
A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Black women ages 18-50 * clinically diagnosed with HIV/AIDS * Speak and comprehend English
Exclusion criteria
* pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 74 |
| 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. | 74 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 10 | 8 |
Baseline characteristics
| Characteristic | Control | Intervention: 90 DAYS Film | Total |
|---|---|---|---|
| Age, Continuous | 31.64 years STANDARD_DEVIATION 6.65 | 32.64 years STANDARD_DEVIATION 7.73 | 32.15 years STANDARD_DEVIATION 7.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 74 Participants | 74 Participants | 148 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants | 66 Participants | 130 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized sex female | 64 Participants | 66 Participants | 130 Participants |
| Sex/Gender, Customized sex male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized sex not reported | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Day 1 post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale | 4.19 score on a scale | Standard Deviation 0.82 |
| Treatment | HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale | 4.45 score on a scale | Standard Deviation 0.66 |
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.
Time frame: Day 1 post test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire | 2.93 score on a scale | Standard Deviation 1.07 |
| Treatment | HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire | 2.95 score on a scale | Standard Deviation 1.14 |
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.
Time frame: Day 1 post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Medical Adherence Intentions as Measured by the Medical Adherence Scale | 2.56 score on a scale | Standard Deviation 1.43 |
| Treatment | Medical Adherence Intentions as Measured by the Medical Adherence Scale | 2.53 score on a scale | Standard Deviation 1.42 |