Finishing HIV Project

University of Miami

Status: Enrolling

Conditions: Hiv

Treatments: Behavioral: Social network intervention; Other: Control group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06406049

20220377

R01AI169643 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 624 estimated patients

Sex: Male

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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624 participants in 2 patient groups

I want "Yo Quiero" Control Group

Active Comparator group

Description:

Participants will receive the standard of care for up to 15-months

Treatment:

Other: Control group

Friend "Amigx" Social network intervention

Experimental group

Description:

Participant will receive a social network intervention for up to 15-months

Treatment:

Behavioral: Social network intervention