NCT06406049 · University of Miami
Finishing HIV Project
What this study is about
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
View original scientific description
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
Interventions
OTHER
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.
BEHAVIORAL
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 measures
Number of participants that report using PrEP
Time frame: Up to 12-months
PrEP initiation will be measured by analyzing the number of participants that initiate PrEP divided by the total number of participants
Number of Dried Blood Spot (DBS) tests that report PrEP use
Time frame: Up to 12-months
PrEP initiation will be measured by analyzing the number of DBS tests that report PrEP use divided by the total number of participants
Number of participants that bring a proof of PrEP prescription
Time frame: Up to 12-months
PrEP initiation will be measured by analyzing the number of participants that bring proof of a PrEP prescription divided by the total number of participants
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Being 18 to 54 years of age
- Being a cis-gender male
- 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
- Self-reported status as HIV negative
- Willing to be tested for HIV
Exclusion criteria
- 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
- \<18 years old or \>54 years old
- Self-reported living with HIV
- Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
- Refusal of HIV test
- Identifies as Non-Latinx
- Individuals enrolled in other PrEP initiation interventions
- Individuals with an active PrEP prescription in the last 6-months (oral or injectable)
Where
- Miami, Florida
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations