Tell Me More ("Dime Mas")

University of Miami

Status: Enrolling

Conditions: Mental Health Issue; HIV

Treatments: Behavioral: Tell Me More ("Dime Mas"); Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")]; Behavioral: Standard Community Outreach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06063083

20201189

K23MD015690 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will be used to develop a program to help Latino men who have sex with men obtain pre-exposure prophylaxis (PrEP), HIV testing, and behavioral health services. The project will then involve a pilot test of this program with a community partner.

Enrollment: 90 estimated patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Identify as Latino/Hispanic
• identify as a sexual minority man (e.g., gay, bisexual) and/or a man who has sex with men
• age 18 years or older
• English and/or Spanish speaking
• self-report an HIV-negative or unknown HIV status
• currently reside in the greater Miami area
• PrEP eligible (based on Centers for Disease Control (CDC) criteria) and not currently taking PrEP adherently
• self-report experiencing one or more clinically significant behavioral health concerns (mental health, substance use) and/or are not currently receiving behavioral health services or self-report an unmet need for behavioral health services

Exclusion criteria

• Unable to provide consent
• Opinion of the PI that the participant would be at risk for harm to self or others
• Have a medical or psychiatric condition that would interfere with ability to participate in study procedures in the opinion of the PI
• Involvement in any other HIV prevention or behavioral health study that may interfere with the ability to test major study outcomes (evaluated by the PI on a case-by-case basis)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Tell Me More ("Dime Mas") group

Experimental group

Description:

Participants will get the Tell Me More ("Dime Mas") program within up to 6 months.

Treatment:

Behavioral: Standard Community Outreach

Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")]

Behavioral: Tell Me More ("Dime Mas")

Peer Ambassador Stories [Listen Miami ("Oye Miami")] group

Experimental group

Description:

Participants will get the Peer Ambassador Stories \[Listen Miami ("Oye Miami")\] within up to 6 months.

Treatment:

Behavioral: Standard Community Outreach

Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")]

Standard Community Outreach group

Active Comparator group

Description:

Participants will receive standard community outreach within up to 6 months.

Treatment:

Behavioral: Standard Community Outreach