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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05365958
Other study ID # STUDY00003312
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2022
Est. completion date October 31, 2023

Study information

Verified date January 2024
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HIV 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.

Locations

Country Name City State
United States Jacob's Home for Men Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline socio-cultural perceptions of HIV prevention at 3 months followup 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
Primary HIV test intentions: Do you intend to obtain a HIV test? (single item) To observe whether the podcast video significantly influenced intentions to obtain a HIV test. To be measured 1 month after film viewing
Primary HIV test intentions: Do you intend to obtain a HIV test? (single item) To observe whether the podcast video significantly influenced intentions to obtain a HIV test. To be measured 3 months after film viewing
Primary HIV test behavior: Have you obtained a HIV test (-you will not be required to disclose the results of this test)? (single item) To observe whether the podcast video significantly influenced behavior of obtaining a HIV test. To be measured 1 month after film viewing
Primary HIV test behavior: Have you obtained a HIV test (-you will not be required to disclose the results of this test)? (single item) To observe whether the podcast video significantly influenced behavior of obtaining a HIV test. To be measured 3 months after film viewing
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