Hiv
Conditions
Brief summary
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
Interventions
OTHERControl 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.
BEHAVIORALSocial 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.
Sponsors
University of Miami
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 54 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that report using PrEP | 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 |
| Number of Dried Blood Spot (DBS) tests that report PrEP use | 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 |
| Number of participants that bring a proof of PrEP prescription | 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
| Measure | Time frame | Description |
|---|---|---|
| PrEP knowledge measured by PrEP knowledge question | 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. |
| Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence | 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 |
Countries
United States
Contacts
CONTACTMariano Kanamori, PhD
PRINCIPAL_INVESTIGATORMariano Kanamori, PhD
University of Miami
Outcome results
None listed