e-HERO: Ending the HIV Epidemic in Rural Oklahoma

Human Immunodeficiency Virus (HIV) Clinical Trial

— e-HERO  

Official title:

e-HERO: Ending the HIV Epidemic in Rural Oklahoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664802
• Other study ID #: NAU IRB Protocol ID: 1827963-2
• Secondary ID: 3U54MD012388-05S
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Northern Arizona University
• Contact: Julie Baldwin, Ph.D.
• Phone: 9285236566
• Email: Julie.Baldwin[@]nau.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 17 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Northern Arizona University	National Institute on Minority Health and Health Disparities (NIMHD), Oklahoma State University, Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV testing uptake	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	HIV testing intention	Intention to get tested for HIV is assessed on a 6-point Likert scale (Extremely unlikely to get tested to Extremely likely to get tested).	Baseline, 1 month, and 3 months
Secondary	STI testing intention	Intention to get tested for STIs is assessed on a 6-point Likert scale (Extremely unlikely to get tested to Extremely likely to get tested).	Baseline, 1 month, and 3 months
Secondary	PrEP consult with medical provider	Single-item measure assessing if they have consulted with a medical provider among PrEP within the last month and/or 3 months.	1 month and 3 months
Secondary	Condom use	Single-item assessment of condom use with sexual partner during the last sexual event.	Baseline, 1 month, and 3 months