- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05664802
e-HERO: Ending the HIV Epidemic in Rural Oklahoma (e-HERO)
June 30, 2026 updated by: Julie Baldwin, Northern Arizona University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
72
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 Locations
-
-
Arizona
-
Flagstaff, Arizona, United States, 86011-4065
- Northern Arizona University
-
-
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
17 years to 29 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study.
- HIV diagnosis
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: e-HERO 2.0
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.
|
A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.
|
|
Active Comparator: e-HERO 1.0
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.
|
A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessed at the end of month 3 of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV Testing Intention
Time Frame: Baseline, 1 month, and 3 months
|
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.
|
Baseline, 1 month, and 3 months
|
|
STI Testing Intention
Time Frame: Baseline, 1 month, and 3 months
|
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.
|
Baseline, 1 month, and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Baldwin, Ph.D., Northern Arizona University
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)
December 1, 2022
Primary Completion (Actual)
June 19, 2024
Study Completion (Actual)
June 19, 2024
Study Registration Dates
First Submitted
December 16, 2022
First Submitted That Met QC Criteria
December 16, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
June 30, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Behavior
- Sexual Behavior
- Acquired Immunodeficiency Syndrome
- Coitus
Other Study ID Numbers
- NAU IRB Protocol ID: 1827963-2
- 3U54MD012388-05S2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.