Helping Latinx Men Reduce HIV Risk

FINISHING HIV: An Ending the HIV Epidemic (EHE) Model for Latinx Integrating One-Stop-Shop Pre-Exposure Prophylaxis (PrEP) Services, a Social Network Support Program and a National Pharmacy Chain

This study is trying to see if a support program can help Latinx men aged 18 to 54 adopt safer behaviors to lower their risk of HIV.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 624 (estimated)
• Ages: 18 Years to 54 Years
• Sex: Male
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06406049 on ClinicalTrials.gov

What this trial studies

This study focuses on promoting healthy behaviors and reducing the risk of HIV among Latinx men aged 18 to 54. Participants will engage in a social network intervention designed to encourage safer practices and provide support. The study includes a control group for comparison, and participants must meet specific criteria related to their sexual health and behaviors. The goal is to gather insights that can lead to effective strategies for HIV prevention in this demographic.

Who should consider this trial

Good fit: Ideal candidates are HIV-negative cis-gender men aged 18 to 54 who have engaged in specific high-risk behaviors in the last six months.

Not a fit: Patients who are HIV-positive or do not meet the specified high-risk behavior criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly lower the risk of HIV among Latinx men and improve their overall health outcomes.

How similar studies have performed: Other studies targeting similar populations and interventions have shown promise in reducing HIV risk, indicating that this approach may be effective.

Eligibility criteria

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)

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Mariano Kanamori, PhD — University of Miami
• Study coordinator: Mariano Kanamori, PhD

Conditions Hiv