e-HERO: Ending the HIV Epidemic in Rural Oklahoma

NCT ID: NCT05664802

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-08-30

Brief 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. 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.

Conditions

Human Immunodeficiency Virus (HIV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

e-HERO: Ending the HIV Epidemic in Rural Oklahoma

Intervention Type: BEHAVIORAL

A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.

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.

Group Type: ACTIVE_COMPARATOR

e-HERO: Ending the HIV Epidemic in Rural Oklahoma

Intervention Type: BEHAVIORAL

A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.

Interventions

e-HERO: Ending the HIV Epidemic in Rural Oklahoma

A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Julie Baldwin

Regents' Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Baldwin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northern Arizona University

Locations

Northern Arizona University

Flagstaff, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie Baldwin, Ph.D.

Role: CONTACT

Julie.Baldwin@nau.edu

9285236566

Randolph Hubach, Ph.D.

Role: CONTACT

rhubach@purdue.edu

7654961040

Facility Contacts

Julie Baldwin, Ph.D.

Role: primary

Julie.Baldwin@nau.edu

928-523-6566

Other Identifiers

3U54MD012388-05S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NAU IRB Protocol ID: 1827963-2

Identifier Type: -

Identifier Source: org_study_id