HIV Prevention
Conditions
Keywords
HIV Prevention, African Americans, Health Disparities
Brief summary
Given the continued impact of HIV among African Americans, there is still an urgent need to expand prevention efforts and HIV testing in African American communities. Heterosexual individuals may acquire and spread infection directly through heterosexual contact, bi-sexual sexual contact, and/or indirectly through homosexual sexual contact. Evidence-based interventions (EBIs) have been shown to increase consistent condom use, decrease sexual partners, and increase HIV testing; however, traditionally-implemented EBIs may not be accessible to communities given the resources and expertise needed to implement them. This project seeks to: 1) assess feasibility for the development of two theory- based, video podcast-delivered, HIV prevention interventions for self-identified heterosexual African American males and females; and 2) evaluate their feasibility & effectiveness (pilot). The investigators will develop the two (male and female) video podcasts that maintain the theoretical integrity of two established Centers for Disease Control evidence-based behavioral HIV prevention interventions. The assessment phase will consist of leveraging African American community stakeholders and experts in the development of the podcast content. The effectiveness phase will consist of broadcasting the podcasts for participants and evaluating psychosocial factors related to HIV prevention at 1 and 3 month follow-ups. This intervention is the first of its kind and has the potential to increase HIV protective behaviors in this hard-to-reach and medically underserved population. The resulting interventions are expected to be easily disseminated throughout the African American communities, with the potential to reduce HIV- related disparities within this population. This study will impact and advance the field by demonstrating feasibility and effectiveness for a novel mode of intervention engagement within HIV prevention science, serve as valuable preliminary data for a larger R01 trial, and foster HIV prevention awareness within the African American community.
Interventions
BEHAVIORALHIV Podcast for Heterosexual African American Adults
The video podcast will deliver HIV prevention messages using entertainment education and behavioral journalism, and film production techniques such as talking head video, interview, animations, & live-action skits. The research team will work closely with the production company in scripting the video vignettes and sequences, ensuring that video content reflects salient domains captured in the concept mapping research development phase of the study.
Sponsors
University of Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* self-identify as African American * speak and read English * 18 years old or older * not currently or previously diagnosed with HIV
Exclusion criteria
• currently or previously diagnosed with HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Condom Use Self-Efficacy (From Baseline to 1 Month Follow-up) | To be measured immediately before film viewing (baseline) and at 1 month follow-up | A change between baseline and 1 month regarding condom use self-efficacy scale scores. Results reflect mean difference and mean standard deviation in a repeated measures t-test analysis. The 5-item subscale scores were summed and averaged across participants, yielding an average scale score range of 1-5; higher scale values indicating greater self-efficacy to use condoms. Scale scores were assessed for participants immediately before the intervention and 1 month after the intervention. The method used was repeated measures t-test. The analysis reports the group average scale score and standard deviation for participants at 1 month followup. |
| Condom Use Intention Item (1 Month Followup) | To be measured 1 month after film viewing | Uses the condom use intention item (average) of the measure. I plan to use condoms the next time I have sex. Item was scaled from 1-strongly disagree to 5-strongly agree. Higher scale scores indicate greater intention to use a condom during intercourse; Lower scale scores indicate lesser intention to use a condom during intercourse.The item was summed across participants, separately for baseline and 1 month followup to yield a pretest group mean average (baseline) and a 1 month followup group mean average. The method used was repeated measures t-test, which tested group mean differences between baseline (pretest average) and 1 month followup average. The analysis reports the group average scale score and standard deviation for participants at 1 month followup. |
| HIV Test Intentions (Single Item) | 1 month after film viewing | Uses a single item I intend to obtain an HIV test within the next 2 months? Item was scaled from 1-strongly disagree to 5-strongly agree. Higher scale scores indicate greater intention to acquire an HIV test; Lower scale scores indicate less intention to acquire an HIV test.The item scores were summed across participants, separately for baseline and 1 month followup to yield a pretest group mean average (baseline) and a 1 month followup group mean average. The method used was repeated measures t-test, which tested group mean differences between baseline (pretest average) and 1 month followup average. The analysis reports the group average scale score and standard deviation for participants at 1 month followup. |
| Number of Participants With Who Have Obtained a HIV Test at 1 Month After Film Viewing | To be measured 1 month after film viewing | To observe whether the film viewing influenced behavior of obtaining a HIV test at 1 month followup. Outcome was measured with a single item: Have you obtained an HIV test (-you will not be required to disclose the results of this test)? Item was scaled on a nominal scale of measurement as (0) No, (1) Maybe, and (2) Yes. A count of Yes (converted to percentage) was used as the primary outcome. |
| Number of Participants With Who Have Obtained a HIV Test at 3 Months After Film Viewing | To be measured 3 months after film viewing | To observe whether the film viewing influenced behavior of obtaining a HIV test at 3 month followup. Outcome was measured with a single item: Have you obtained an HIV test (-you will not be required to disclose the results of this test)? Item was scaled on a nominal scale of measurement as (0) No, (1) Maybe, and (2) Yes. A count of Yes (converted to percentage) was used as the primary outcome. |
Countries
United States
Participant flow
Recruitment details
February 11, 2022 Recruitment at local community events, via social media, flyer distribution, churches.
Participants by arm
| Arm | Count |
|---|---|
| African American Heterosexuals Group participated in the pretest, intervention, & posttest/follow-up. (Single arm study) | 128 |
| Total | 128 |
Baseline characteristics
| Characteristic | African American Heterosexuals |
|---|---|
| Age, Continuous | 36.2 aggregate age STANDARD_DEVIATION 3.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HIV-Knowledge Questionnaire [HIV KQ-14] | 10.2 scores STANDARD_DEVIATION 2.2 |
| Psychosocial Aspects of HIV Prevention Behavior: Condom Use Intention Item | 3.4 scores STANDARD_DEVIATION 1.7 |
| Psychosocial Aspects of HIV Prevention Behavior: Condom Use Self-Efficacy Subscale | 3.0 scores STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 128 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 128 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
Primary
Change in Condom Use Self-Efficacy (From Baseline to 1 Month Follow-up)
A change between baseline and 1 month regarding condom use self-efficacy scale scores. Results reflect mean difference and mean standard deviation in a repeated measures t-test analysis. The 5-item subscale scores were summed and averaged across participants, yielding an average scale score range of 1-5; higher scale values indicating greater self-efficacy to use condoms. Scale scores were assessed for participants immediately before the intervention and 1 month after the intervention. The method used was repeated measures t-test. The analysis reports the group average scale score and standard deviation for participants at 1 month followup.
Time frame: To be measured immediately before film viewing (baseline) and at 1 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| African American Heterosexuals | Change in Condom Use Self-Efficacy (From Baseline to 1 Month Follow-up) | 4.4 score on a scale | Standard Deviation 0.6 |
p-value: <0.001Repeated Measures t-test of differences
Primary
Condom Use Intention Item (1 Month Followup)
Uses the condom use intention item (average) of the measure. I plan to use condoms the next time I have sex. Item was scaled from 1-strongly disagree to 5-strongly agree. Higher scale scores indicate greater intention to use a condom during intercourse; Lower scale scores indicate lesser intention to use a condom during intercourse.The item was summed across participants, separately for baseline and 1 month followup to yield a pretest group mean average (baseline) and a 1 month followup group mean average. The method used was repeated measures t-test, which tested group mean differences between baseline (pretest average) and 1 month followup average. The analysis reports the group average scale score and standard deviation for participants at 1 month followup.
Time frame: To be measured 1 month after film viewing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| African American Heterosexuals | Condom Use Intention Item (1 Month Followup) | 4.1 score on a scale | Standard Deviation 1.1 |
p-value: <0.001Repeated Measures t-test of differences
Primary
HIV Test Intentions (Single Item)
Uses a single item I intend to obtain an HIV test within the next 2 months? Item was scaled from 1-strongly disagree to 5-strongly agree. Higher scale scores indicate greater intention to acquire an HIV test; Lower scale scores indicate less intention to acquire an HIV test.The item scores were summed across participants, separately for baseline and 1 month followup to yield a pretest group mean average (baseline) and a 1 month followup group mean average. The method used was repeated measures t-test, which tested group mean differences between baseline (pretest average) and 1 month followup average. The analysis reports the group average scale score and standard deviation for participants at 1 month followup.
Time frame: 1 month after film viewing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| African American Heterosexuals | HIV Test Intentions (Single Item) | 4.3 score on a scale | Standard Deviation 0.6 |
Primary
Number of Participants With Who Have Obtained a HIV Test at 1 Month After Film Viewing
To observe whether the film viewing influenced behavior of obtaining a HIV test at 1 month followup. Outcome was measured with a single item: Have you obtained an HIV test (-you will not be required to disclose the results of this test)? Item was scaled on a nominal scale of measurement as (0) No, (1) Maybe, and (2) Yes. A count of Yes (converted to percentage) was used as the primary outcome.
Time frame: To be measured 1 month after film viewing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| African American Heterosexuals | Number of Participants With Who Have Obtained a HIV Test at 1 Month After Film Viewing | 18 Participants |
Primary
Number of Participants With Who Have Obtained a HIV Test at 3 Months After Film Viewing
To observe whether the film viewing influenced behavior of obtaining a HIV test at 3 month followup. Outcome was measured with a single item: Have you obtained an HIV test (-you will not be required to disclose the results of this test)? Item was scaled on a nominal scale of measurement as (0) No, (1) Maybe, and (2) Yes. A count of Yes (converted to percentage) was used as the primary outcome.
Time frame: To be measured 3 months after film viewing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| African American Heterosexuals | Number of Participants With Who Have Obtained a HIV Test at 3 Months After Film Viewing | 53 Participants |