NCT05664802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2024

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

December 16, 2022

Last Update Submit

April 7, 2026

Conditions

Keywords

Sexual and Gender Minorities; American Indian; HIV Testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • HIV testing intention

    Baseline, 1 month, and 3 months

  • STI testing intention

    Baseline, 1 month, and 3 months

  • PrEP consult with medical provider

    1 month and 3 months

  • Condom use

    Baseline, 1 month, and 3 months

Study Arms (2)

e-HERO 2.0

EXPERIMENTAL

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.

Behavioral: e-HERO: Ending the HIV Epidemic in Rural Oklahoma

e-HERO 1.0

ACTIVE COMPARATOR

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.

Behavioral: e-HERO: Ending the HIV Epidemic in Rural Oklahoma

Interventions

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

e-HERO 1.0e-HERO 2.0

Eligibility Criteria

Age17 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must identify as male, inclusive of transgender men.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study.
  • HIV diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011-4065, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCoitus

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehavior

Study Officials

  • Julie Baldwin, Ph.D.

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Centralized, computer-based group assignment using permuted blocks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Regents' Professor and Director

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

December 1, 2022

Primary Completion

June 19, 2024

Study Completion

June 19, 2024

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations