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e-HERO: Ending the HIV Epidemic in Rural Oklahoma (e-HERO)

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-HERO: Ending the HIV Epidemic in Rural Oklahoma
Sponsored by
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring Sexual and Gender Minorities; American Indian; HIV Testing

Eligibility Criteria

17 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Northern Arizona UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

e-HERO 2.0

e-HERO 1.0

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HIV testing uptake
HIV testing uptake is assessed through the request of an at-home rapid HIV test through the e-HERO platforms.

Secondary Outcome Measures

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).
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).
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.
Condom use
Single-item assessment of condom use with sexual partner during the last sexual event.

Full Information

First Posted
December 16, 2022
Last Updated
December 16, 2022
Sponsor
Northern Arizona University
Collaborators
Oklahoma State University, Purdue University, National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05664802
Brief Title
e-HERO: Ending the HIV Epidemic in Rural Oklahoma
Acronym
e-HERO
Official Title
e-HERO: Ending the HIV Epidemic in Rural Oklahoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Arizona University
Collaborators
Oklahoma State University, Purdue University, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
Sexual and Gender Minorities; American Indian; HIV Testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Centralized, computer-based group assignment using permuted blocks.
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
e-HERO 2.0
Arm Type
Experimental
Arm Description
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.
Arm Title
e-HERO 1.0
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
e-HERO: Ending the HIV Epidemic in Rural Oklahoma
Intervention Description
A behavioral intervention utilizing online platforms to assess the impact of cultural tailoring of health education material.
Primary Outcome Measure Information:
Title
HIV testing uptake
Description
HIV testing uptake is assessed through the request of an at-home rapid HIV test through the e-HERO platforms.
Time Frame
Assessed at the end of month 3 of the intervention.
Secondary Outcome Measure Information:
Title
HIV testing intention
Description
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).
Time Frame
Baseline, 1 month, and 3 months
Title
STI testing intention
Description
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).
Time Frame
Baseline, 1 month, and 3 months
Title
PrEP consult with medical provider
Description
Single-item measure assessing if they have consulted with a medical provider among PrEP within the last month and/or 3 months.
Time Frame
1 month and 3 months
Title
Condom use
Description
Single-item assessment of condom use with sexual partner during the last sexual event.
Time Frame
Baseline, 1 month, and 3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants must identify as male, inclusive of transgender men.
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Baldwin, Ph.D.
Phone
9285236566
Email
Julie.Baldwin@nau.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Randolph Hubach, Ph.D.
Phone
7654961040
Email
rhubach@purdue.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Baldwin, Ph.D.
Organizational Affiliation
Northern Arizona University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Arizona University
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86011-4065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Baldwin, Ph.D.
Phone
928-523-6566
Email
Julie.Baldwin@nau.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

e-HERO: Ending the HIV Epidemic in Rural Oklahoma

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