Clinical trial NCT05664802: e-HERO: Ending the HIV Epidemic in Rural Oklahoma
Official title: e-HERO: Ending the HIV Epidemic in Rural Oklahoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: Sexual and Gender Minorities; American Indian; HIV Testing
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
name: Purdue University
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-12-27
Enrollment: 200
Sex: MALE
Minimum age (years): 17
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Centralized, computer-based group assignment using permuted blocks.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: HIV testing uptake
timeFrame: Assessed at the end of month 3 of the intervention.
Secondary outcomes:
measure: HIV testing intention
timeFrame: Baseline, 1 month, and 3 months
measure: STI testing intention
timeFrame: Baseline, 1 month, and 3 months
measure: PrEP consult with medical provider
timeFrame: 1 month and 3 months
measure: Condom use
timeFrame: Baseline, 1 month, and 3 months
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Julie Baldwin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: