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Recruiting NCT06406049

Finishing HIV Project

No phase Interventional Hiv

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control group-Standard Health Promotion, Social network intervention.
Who it may be relevant to
Registry conditions: Hiv. Basic parameters: 18 years — 54 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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 st

Primary outcome measures

  • Number of participants that report using PrEP [Time frame: Up to 12-months]
  • Number of Dried Blood Spot (DBS) tests that report PrEP use [Time frame: Up to 12-months]
  • Number of participants that bring a proof of PrEP prescription [Time frame: Up to 12-months]
Secondary outcome measures (2)
  • PrEP knowledge measured by PrEP knowledge question [Time frame: Up to 12-months]
  • Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence [Time frame: Up to 12-months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06406049 · 20250806 · R01AI169643 · 20220377

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗