Human Immunodeficiency Virus (HIV)
Conditions
Keywords
Sexual and Gender Minorities; American Indian; HIV Testing
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.
Interventions
BEHAVIORALe-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.
Sponsors
Northern Arizona University
Oklahoma State University
Purdue University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Centralized, computer-based group assignment using permuted blocks.
Eligibility
Sex/Gender
MALE
Age
17 Years to 29 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Uptake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Intention | 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. |
| STI Testing Intention | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulie Baldwin, Ph.D.
Northern Arizona University
Participant flow
Recruitment details
Recruitment occurred between Dec 1, 2022 and June 19, 2024.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 23.35 Years STANDARD_DEVIATION 4.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 37 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 37 |
| other Total, other adverse events | 0 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 |
Outcome results
None listed