- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05365958
Podcasting HIV Prevention Within African American Communities
Podcasting HIV Prevention Within African American Communities to Decrease New Infection
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77051
- Jacob's Home for Men
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: African American Heterosexuals
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Condom Use Self-Efficacy (From Baseline to 1 Month Follow-up)
Time Frame: 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. |
To be measured immediately before film viewing (baseline) and at 1 month follow-up
|
|
Number of Participants With Who Have Obtained a HIV Test at 1 Month After Film Viewing
Time Frame: 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.
|
To be measured 1 month after film viewing
|
|
Number of Participants With Who Have Obtained a HIV Test at 3 Months After Film Viewing
Time Frame: 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.
|
To be measured 3 months after film viewing
|
|
Condom Use Intention Item (1 Month Followup)
Time Frame: 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.
|
To be measured 1 month after film viewing
|
|
HIV Test Intentions (Single Item)
Time Frame: 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.
|
1 month after film viewing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Urogenital Diseases
- Genital Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- STUDY00003312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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