Finishing HIV Project

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

Study Overview

• Status: Recruiting
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Social network intervention; Other: Control group-Standard Health Promotion

• Study Type: Interventional
• Enrollment (Estimated): 624
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariano Kanamori, PhD; Phone Number: (305) 2430595; Email: mjk194@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Mariano Kanamori, PhD; Phone Number: 305-243-0595; Email: mjk194@miami.edu
      • Principal Investigator: Mariano Kanamori, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I want "Yo Quiero" Control Group; Participants will receive the standard of care for up to 15-months	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.
Experimental: Friend "Amigx" Social network intervention; Participant will receive a social network intervention for up to 15-months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP knowledge measured by PrEP knowledge question	Scores range from 1 (I don't know) to 5 (99% or more than 99% effective). Higher scores indicate adequate PrEP knowledge.	Up to 12-months
Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence	PrEP adherence will be measured by analyzing the number of DBS tests that report PrEP adherence divided by the total number of participants that initiate PrEP during the study	Up to 12-months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Mariano Kanamori, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20250806; 20220377 (Other Identifier: University of Miami IRB); R01AI169643 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No