Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
624 participants
INTERVENTIONAL
2024-11-08
2029-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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I want "Yo Quiero" Control Group
Participants will receive the standard of care for up to 15-months
Control group
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.
Friend "Amigx" Social network intervention
Participant will receive a social network intervention for up to 15-months
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.
Interventions
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Control group
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
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
54 Years
MALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Miami
OTHER
Responsible Party
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Mariano Juan Kanamori Nishimura
Associate Professor
Principal Investigators
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Mariano Kanamori, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Mariano Kanamori, PhD
Role: primary
Mariano Kanamori, PhD
Role: backup
Other Identifiers
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20220377
Identifier Type: -
Identifier Source: org_study_id