Finishing HIV Project

Официальное название

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

Обзор

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

Вмешательства

• Другое 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.
• Поведенческое 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

Первичные конечные точки

• Number of participants that report using PrEP [Срок оценки: Up to 12-months]
• Number of Dried Blood Spot (DBS) tests that report PrEP use [Срок оценки: Up to 12-months]
• Number of participants that bring a proof of PrEP prescription [Срок оценки: Up to 12-months]

Вторичные конечные точки (2)

• PrEP knowledge measured by PrEP knowledge question [Срок оценки: Up to 12-months]
• Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence [Срок оценки: Up to 12-months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT06406049 · 20250806 · R01AI169643 · 20220377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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