NCT05365958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 16, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

April 28, 2022

Results QC Date

February 28, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

HIV PreventionAfrican AmericansHealth Disparities

Outcome Measures

Primary Outcomes (5)

  • 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.

    To be measured immediately before film viewing (baseline) and at 1 month follow-up

  • 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.

    To be measured 1 month after film viewing

  • 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.

    1 month after film viewing

  • 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.

    To be measured 1 month after film viewing

  • 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.

    To be measured 3 months after film viewing

Study Arms (1)

African American Heterosexuals

EXPERIMENTAL
Behavioral: HIV Podcast for Heterosexual African American Adults

Interventions

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.

African American Heterosexuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-identify as African American
  • speak and read English
  • years old or older
  • not currently or previously diagnosed with HIV

You may not qualify if:

  • currently or previously diagnosed with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacob's Home for Men

Houston, Texas, 77051, United States

Location

Results Point of Contact

Title
Dr. Chakema Carmack, Ph.D., Associate Professor
Organization
University of Houston

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 9, 2022

Study Start

February 11, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

October 6, 2025

Results First Posted

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations