HIV PreventionNCT05365958
Podcasting HIV Prevention Within African American Communities
A study testing HIV Podcast for Heterosexual African American Adults in people with HIV Prevention, run by University of Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- HIV Podcast for Heterosexual African American Adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as African American
- speak and read English
- 18 years old or older
- not currently or previously diagnosed with HIV
Who cannot join
- currently or previously diagnosed with HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- HIV Prevention
- Being tested
- HIV Podcast for Heterosexual African American Adults
- Keywords
- HIV Prevention, African Americans, Health Disparities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Podcast for Heterosexual African American AdultsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| African American Heterosexuals | Experimental | Not described Receives: Behavioral: HIV Podcast for Heterosexual African American Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: To be measured 3 months after film viewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start11 Feb 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chakema Carmack, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365958
- Sponsor's protocol ID
- STUDY00003312
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2022
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Podcasting HIV Prevention Within African American Communities to Decrease New Infection
- ClinicalTrials.gov ID
- NCT05365958
- Acronym / sponsor ID
- STUDY00003312
- Conditions
- HIV Prevention
- Keywords
- HIV Prevention, African Americans, Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African American Heterosexuals | Experimental | Behavioral: HIV Podcast for Heterosexual African American Adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identify as African American
- speak and read English
- 18 years old or older
- not currently or previously diagnosed with HIV
Key exclusion criteria (1 listed)
- currently or previously diagnosed with HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Podcast for Heterosexual African American AdultsThe 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. | Behavioural | African American Heterosexuals |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Podcast for Heterosexual African American Adults in people with HIV Prevention, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.