Recruiting

HIV Project

Sponsor:

University of Miami

Code:

NCT06406049

Conditions

Hiv

Eligibility Criteria

Sex: Male

Age: 18 - 54

Healthy Volunteers: Accepted

Interventions

Control group-Standard Health Promotion

Social network intervention

Study Details

Brief summary:

This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.

Conditions

Hiv

Study ID

NCT06406049

Start date

Nov 8, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 54

Healthy Volunteers: Accepted

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Being 18 to 54 years of age
4. Being a cis-gender male
5. Self-report one or more of the following behaviors and health conditions in the last 6 months which meet the Centers for Disease Control and Prevention (CDC) clinical guidelines for PrEP eligibility

  • Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
  • Sex with a partner who is living with HIV
  • Sex without a condom with two or more partners whose HIV status were unknown
  • Injection drug use and sharing injection equipment
6. Self-reported status as HIV negative
7. Willing to be tested for HIV

Exclusion Criteria

1. Display diminished capacity to consent because of:

  • An inability to provide informed consent (e.g., cognitive impairment)
  • Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with Collaborative Institutional Training Initiative (CITI) Human Subjects Research and National Institutes of Health (NIH) Good Clinical Practice training
2. <18 years old or >54 years old
3. Self-reported living with HIV
4. Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
5. Refusal of HIV test
6. Identifies as Non-Latinx
7. Individuals enrolled in other PrEP initiation interventions
8. Individuals with an active PrEP prescription in the last 6-months (oral or injectable)

Study Design

Enrollment

624 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: I want "Yo Quiero" Control Group

Participants will receive the standard of care for up to 15-months

experimental: Friend "Amigx" Social network intervention

Participant will receive a social network intervention for up to 15-months

Interventions

Control group-Standard Health Promotion

Participants will receive the standard of care (beginning of the study) which includes sexual health information once in-person for up to 15 minutes for the duration of the study.

Social network intervention

Participants will come to the study location for up to 2 hours three times (beginning of the study, 6-month and 12-month follow-ups) during the duration of the study. During the study, participants will receive sexual health counseling for HIV prevention. Additionally participants will receive information and resources for PrEP usage. Participants will be encouraged to share sexual health information two times (three and nine months after the beginning of the study) during the duration of the study.

Primary outcome measure

  • Number of participants that report using PrEP [ Time Frame: Up to 12-months ]
  • Number of Dried Blood Spot (DBS) tests that report PrEP use [ Time Frame: Up to 12-months ]
  • Number of participants that bring a proof of PrEP prescription [ Time Frame: Up to 12-months ]

Central Contacts and Locations

Central contacts

Mariano Kanamori, PhD

(305) 2430595mjk194@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Mariano Kanamori, PhD

305-243-0595mjk194@miami.edu

Principal Investigator:

Mariano Kanamori, PhD

More Information

Sponsor

University of Miami

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-20.