Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06406049

Finishing HIV Project

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–54 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Mariano Kanamori, PhD

CONTACT

[email protected]

305-243-0595

Mariano Kanamori, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. PrEP knowledge measured by PrEP knowledge question

    Time frame: Up to 12-months

    Scores range from 1 (I don't know) to 5 (99% or more than 99% effective). Higher scores indicate adequate PrEP knowledge.

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

    Time frame: Up to 12-months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mariano Kanamori, PhD

CONTACT

[email protected]

(305) 2430595

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 9, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.