Tell Me More ("Dime Mas")

NCT06063083 | Completed

• 2 other identifiers: 20201189K23MD015690
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• Change in PrEP Engagement, as measured by the PrEP cascade questionnaire

  This will be assessed using the PrEP cascade measure, which specified five "levels" of PrEP engagement (i.e., pre-contemplation, contemplation, preparation, action, and maintenance). We will evaluate this outcome as an ordered-categorical outcome.

  Baseline, 3 months, 6 months

Secondary Outcomes (2)

• Change in Behavioral Health Treatment Engagement, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)

  Baseline, 3 months, 6 months

• Change in Recent (within the last 3 months) HIV testing

  Baseline, 3 months, 6 months

Study Arms (3)

Tell Me More ("Dime Mas") group

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")]; Behavioral: Standard Community Outreach

Standard Community Outreach group

ACTIVE COMPARATOR

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

Behavioral: Standard Community Outreach

Interventions

Tell Me More ("Dime Mas") BEHAVIORAL

Participants will receive an initial approximately 1 hour outreach session followed by up to 3 approximately monthly check-in outreach attempts (approximately 15 minutes each). All study visits can be done in person or remotely. Each contact will involve helping participants get connected to PrEP, HIV testing, and behavioral health treatment.

Tell Me More ("Dime Mas") group

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

Participants will receive a link to a website featuring stories of local Latino MSM using PrEP, HIV testing, and behavioral health treatments. Participants will receive intermittent (based on personal choice) reminders to view the website. The website will also show referrals to services and provide the option to submit a story via written, video, or audio recording. Participants can access the website using a personal electronic device at any time during within the study period.

Peer Ambassador Stories [Listen Miami ("Oye Miami")] group; Tell Me More ("Dime Mas") group

Standard Community Outreach BEHAVIORAL

Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as a man
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Study Officials

• Audrey Harkness, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 2, 2023
• Study Start: January 12, 2024
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)