Human Immunodeficiency Virus (HIV)e-HERONCT05664802
e-HERO: Ending the HIV Epidemic in Rural Oklahoma
A study testing e-HERO: Ending the HIV Epidemic in Rural Oklahoma in people with Human Immunodeficiency Virus (HIV), run by Northern Arizona University at 1 site in United States.
Trial summary
The goal of this study is to increase HIV and syphilis testing and linkage to care, increase condom use, and promote PrEP uptake among sexual minority men (SMM) and American Indian (AI) men in rural Oklahoma, a state that is an Ending the HIV Epidemic (EHE) priority state. Read more about this study
- Who is it for?
- Ages 17 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- e-HERO: Ending the HIV Epidemic in Rural Oklahoma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 19 Jun 2024
- 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 17 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Provide signed and dated informed consent form
- Be willing and able to follow study procedures and instructions and be available for the duration of the study
- Be between 17 and 29 years of age
- Be American Indian or a gay, bisexual, or other man who has sex with men. American Indian status is self-identified-no tribal enrollment verification will be required.
- Be a resident of Oklahoma, in a rural identified county
Who cannot join
- Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study.
- HIV diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Arizona University
Flagstaff, Arizona, 86011-4065
About this study
The goal of this study is to increase HIV and syphilis testing and linkage to care, increase condom use, and promote PrEP uptake among sexual minority men (SMM) and American Indian (AI) men in rural Oklahoma, a state that is an Ending the HIV Epidemic (EHE) priority state. The proposed supplement aims to: refine our preliminary intervention strategy in partnership with a Community Advisory Board (CAB) and rural peer mentors, and to assess feasibility, acceptability, and preliminary impact of the e-HERO intervention.
Read the detailed description
In the U.S., incidence rates of HIV and sexually transmitted infections (STIs) are disproportionately high among gay, bisexual, and other men who have sex with men-referred to herein as sexual minority men (SMM)-compared to men who have sex with women only. Similarly, rates of HIV infection have increased among American Indian (AI) men. This is a two-group, active-control RCT of the online e-HERO intervention. Participants (100 SMM; 100 AI men) will be randomized into two groups in equal proportions. This study evaluates two versions of an online sexual health intervention. The e-HERO intervention includes 10 modules, totaling approximately 2.5 hours of content. Across these modules, e-HERO uses diverse delivery methods (e.g., videos, interactive games) to address HIV and STI knowledge, behavioral skills, HIV and STI testing intention, and instill self-efficacy to primary and secondary prevention behaviors. Those in the intervention condition will also engage in three virtual group discussion sessions with peer mentors. The control condition contains the same number of modules as e-HERO. The control condition contains the same number of modules as e-HERO. The control arm reflects HIV and STI information that is currently available on many websites, with the aim to understand how the cultural tailoring of e-HERO modules improves upon information that is readily available online.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- e-HERO: Ending the HIV Epidemic in Rural Oklahoma
- Keywords
- Sexual and Gender Minorities; American Indian; HIV Testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-HERO: Ending the HIV Epidemic in Rural OklahomaBehavioural
A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.
| Study group | Role | What they receive |
|---|---|---|
| e-HERO 2.0 | Experimental | The e-HERO intervention includes 10 modules, totaling approximately 2.5 hours of content. Across these modules, e-HERO uses diverse delivery methods to address HIV and STI knowledge, behavioral skills, HIV and STI testing intention, and instill self-efficacy to primary and secondary prevention behaviors. Those in the intervention condition will also engage in three virtual group discussion sessions with peer mentors. Receives: Behavioral: e-HERO: Ending the HIV Epidemic in Rural Oklahoma |
| e-HERO 1.0 | Active comparator | e-HERO 1.0 contains the same number of modules as e-HERO. The control arm reflects HIV and STI information that is currently publicly available. Receives: Behavioral: e-HERO: Ending the HIV Epidemic in Rural Oklahoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing Uptake
HIV testing uptake is assessed through the request of an at-home rapid HIV test through the e-HERO platforms.
Measured: Assessed at the end of month 3 of the intervention.
Secondary outcomes (2)
HIV Testing Intention
The outcome scale name is called "Intentions to get tested for HIV", measuring the construct of intention to get tested for HIV in the next 3 months, by asking the 1-item question: "How likely are you to get tested for HIV in the next three months?" The outcome is assessed on a 6-point Likert-type scale.The score range was 1-6, from 1= Extremely unlikely to get tested for HIV to 6=Extremely likely to get tested for HIV. A higher score indicated greater intentions to get tested, which is considered a preferred outcome. There were no subscales.
Measured: Baseline, 1 month, and 3 months
STI Testing Intention
The outcome scale name is called "Intentions to get tested for a Sexually Transmitted Infection", measuring the construct of intentions to get a test for an STI in the next 3 months. The outcome was a 1-item question: "How likely are you to get tested for other STIs besides HIV in the next three months?" The answers were assessed on a 6-point Likert-type scale, with a score ranging from 1-6 (1= Extremely unlikely to get tested for an STI to 6=Extremely likely to get tested for an STI). A higher score indicated greater intentions to get tested, which is considered a preferred outcome. There were no subscales.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Dec 2022
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
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 Human Immunodeficiency Virus (HIV)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Centralized, computer-based group assignment using permuted blocks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University, Purdue University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Julie Baldwin, Northern Arizona University
- Investigators
- Julie Baldwin, Ph.D., Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664802
- Sponsor's protocol ID
- NAU IRB Protocol ID: 1827963-2
- Other IDs
- 3U54MD012388-05S2
- Acronym
- e-HERO
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2022
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-HERO: Ending the HIV Epidemic in Rural Oklahoma
- ClinicalTrials.gov ID
- NCT05664802
- Acronym / sponsor ID
- e-HERO / NAU IRB Protocol ID: 1827963-2
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Sexual and Gender Minorities; American Indian; HIV Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- Oklahoma State University, Purdue University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 27 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to increase HIV and syphilis testing and linkage to care, increase condom use, and promote PrEP uptake among sexual minority men (SMM) and American Indian (AI) men in rural Oklahoma, a state that is an Ending the HIV Epidemic (EHE) priority state. The proposed supplement aims to: refine our preliminary intervention strategy in partnership with a Community Advisory Board (CAB) and rural peer mentors, and to assess feasibility, acceptability, and preliminary impact of the e-HERO intervention.
Detailed description
In the U.S., incidence rates of HIV and sexually transmitted infections (STIs) are disproportionately high among gay, bisexual, and other men who have sex with men-referred to herein as sexual minority men (SMM)-compared to men who have sex with women only. Similarly, rates of HIV infection have increased among American Indian (AI) men. This is a two-group, active-control RCT of the online e-HERO intervention. Participants (100 SMM; 100 AI men) will be randomized into two groups in equal proportions. This study evaluates two versions of an online sexual health intervention. The e-HERO intervention includes 10 modules, totaling approximately 2.5 hours of content. Across these modules, e-HERO uses diverse delivery methods (e.g., videos, interactive games) to address HIV and STI knowledge, behavioral skills, HIV and STI testing intention, and instill self-efficacy to primary and secondary prevention behaviors. Those in the intervention condition will also engage in three virtual group discussion sessions with peer mentors. The control condition contains the same number of modules as e-HERO. The control condition contains the same number of modules as e-HERO. The control arm reflects HIV and STI information that is currently available on many websites, with the aim to understand how the cultural tailoring of e-HERO modules improves upon information that is readily available online.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Centralized, computer-based group assignment using permuted blocks.
| Arm | Type | Receives |
|---|---|---|
| e-HERO 2.0 | Experimental | Behavioral: e-HERO: Ending the HIV Epidemic in Rural OklahomaThe e-HERO intervention includes 10 modules, totaling approximately 2.5 hours of content. Across these modules, e-HERO uses diverse delivery methods to address HIV and STI knowledge, behavioral skills, HIV and STI testing intention, and instill self-efficacy to primary and secondary prevention behaviors. Those in the intervention condition will also engage in three virtual group discussion sessions with peer mentors. |
| e-HERO 1.0 | Active comparator | Behavioral: e-HERO: Ending the HIV Epidemic in Rural Oklahomae-HERO 1.0 contains the same number of modules as e-HERO. The control arm reflects HIV and STI information that is currently publicly available. |
Who may qualify
- Ages
- 17 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Provide signed and dated informed consent form
- Be willing and able to follow study procedures and instructions and be available for the duration of the study
- Be between 17 and 29 years of age
- Be American Indian or a gay, bisexual, or other man who has sex with men. American Indian status is self-identified-no tribal enrollment verification will be required.
- Be a resident of Oklahoma, in a rural identified county
Key exclusion criteria (2 listed)
- Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study.
- HIV diagnosis
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 |
|---|---|---|
| e-HERO: Ending the HIV Epidemic in Rural OklahomaA behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material. | Behavioural | e-HERO 1.0, e-HERO 2.0 |
Primary outcome
HIV Testing Uptake
Time frame: Assessed at the end of month 3 of the intervention.
HIV testing uptake is assessed through the request of an at-home rapid HIV test through the e-HERO platforms.
2 secondary outcomes
HIV Testing Intention
Time frame: Baseline, 1 month, and 3 months
STI Testing Intention
Time frame: Baseline, 1 month, and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Julie Baldwin, Ph.D. principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-HERO: Ending the HIV Epidemic in Rural Oklahoma in people with Human Immunodeficiency Virus (HIV), run by Northern Arizona University 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 5 inclusion and 2 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 27 Jul 2026. 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 27 Jul 2026). 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?
HIV Testing Uptake (time frame: Assessed at the end of month 3 of the intervention.). 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 27 Jul 2026.