- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05365958
Podcasting HIV Prevention Within African American Communities
January 8, 2024 updated by: Chakema Carmack, University of Houston
Podcasting HIV Prevention Within African American Communities to Decrease New Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chakema C Carmack, Ph.D.
- Phone Number: 713-743-6231
- Email: ccarmack@central.uh.edu
Study Contact Backup
- Name: Ezemenari Obasi, Ph.D.
- Phone Number: 713-743-4698
- Email: emobasi@central.uh.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77051
- Jacob's Home for Men
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 from baseline socio-cultural perceptions of HIV prevention at 3 months followup
Time Frame: To be measured immediately before film viewing (baseline) and 1 month after film viewing
|
To observe whether the podcast video significantly changed perceptions of HIV prevention. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive perceptions to cervical cancer prevention |
To be measured immediately before film viewing (baseline) and 1 month after film viewing
|
HIV test intentions: Do you intend to obtain a HIV test? (single item)
Time Frame: To be measured 1 month after film viewing
|
To observe whether the podcast video significantly influenced intentions to obtain a HIV test.
|
To be measured 1 month after film viewing
|
HIV test intentions: Do you intend to obtain a HIV test? (single item)
Time Frame: To be measured 3 months after film viewing
|
To observe whether the podcast video significantly influenced intentions to obtain a HIV test.
|
To be measured 3 months after film viewing
|
HIV test behavior: Have you obtained a HIV test (-you will not be required to disclose the results of this test)? (single item)
Time Frame: To be measured 1 month after film viewing
|
To observe whether the podcast video significantly influenced behavior of obtaining a HIV test.
|
To be measured 1 month after film viewing
|
HIV test behavior: Have you obtained a HIV test (-you will not be required to disclose the results of this test)? (single item)
Time Frame: To be measured 3 months after film viewing
|
To observe whether the podcast video significantly influenced behavior of obtaining a HIV test.
|
To be measured 3 months after film viewing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2022
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
April 28, 2022
First Submitted That Met QC Criteria
May 3, 2022
First Posted (Actual)
May 9, 2022
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 8, 2024
Last Verified
January 1, 2024
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)?
NO
IPD Plan Description
Because this is a feasibility study with a low sample size, the data is preliminary and it is not certain that the data will be appropriate or useful for public dissemination.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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