Finishing HIV Project

NCT06406049 | Recruiting

• 3 other identifiers: 20250806R01AI16964320220377
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hiv

Outcome Measures

Primary Outcomes (3)

• Number of participants that report using PrEP

  PrEP initiation will be measured by analyzing the number of participants that initiate PrEP divided by the total number of participants

  Up to 12-months

• Number of Dried Blood Spot (DBS) tests that report PrEP use

  PrEP initiation will be measured by analyzing the number of DBS tests that report PrEP use divided by the total number of participants

  Up to 12-months

• Number of participants that bring a proof of PrEP prescription

  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

  Up to 12-months

Secondary Outcomes (2)

• PrEP knowledge measured by PrEP knowledge question

  Up to 12-months

• Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence

  Up to 12-months

Study Arms (2)

I want "Yo Quiero" Control Group

ACTIVE COMPARATOR

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

Other: Control group-Standard Health Promotion

Friend "Amigx" Social network intervention

EXPERIMENTAL

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

Behavioral: Social network intervention

Interventions

Control group-Standard Health Promotion OTHER

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.

I want "Yo Quiero" Control Group

Social network intervention BEHAVIORAL

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.

Friend "Amigx" Social network intervention

Eligibility Criteria

• Age: 18 Years - 54 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mariano Kanamori, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano Kanamori, PhD

CONTACT

(305) 2430595; mjk194@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)