Tell Me More ("Dime Mas")

HIV Clinical Trial

Official title:

Addressing Latino Men Who Have Sex With Men (MSM) Health Disparities by Increasing Engagement With Behavioral and HIV Prevention Services: An Implementation Science Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063083
• Other study ID #: 20201189
• Secondary ID: K23MD015690
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Audrey Harkness, PhD
• Phone: 3052841306
• Email: aharkness[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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 18-39 years

• 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

• self-report experiencing one or more clinically significant behavioral health concerns (mental health, substance use) and are not currently receiving 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)

Related Conditions & MeSH terms

• HIV
• Mental Health Issue

Intervention

Behavioral:
• Tell Me More ("Dime Mas")
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.
• Peer Ambassador Stories [Listen Miami ("Oye Miami")]
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.
• Standard Community Outreach
Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PrEP Uptake, as measured by the PrEP cascade questionnaire	Participants will answer questions about interest and use of PrEP (e.g., receiving a prescription, taking PrEP), PrEP modality, PrEP adherence. A composite score will be calculated to determine whether or not the participant reach the "PrEP uptake" level of the PrEP cascade. A score of 1 means that the participant spoke to a provider and were prescribed medication for PrEP. A score of 0 means the participant did not.	Baseline, 3 months, 6 months
Secondary	Change in Behavioral Health Treatment Uptake, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)	Participants will answer questions about interest and use of behavioral health treatment (e.g., number of sessions attended). A composite score will be calculated to determine whether or not the participant reach the "behavioral health treatment uptake" level of the behavioral health cascade. A score of 1 means that the participant received at least one session of behavioral health treatment in the last three months. A score of 0 means the participant did not.	Baseline, 3 months, 6 months
Secondary	Change in Recent (within the last 3 months) HIV testing	Participants will answer a question about being tested in the past three months. A score of 1 means that the participant received at HIV test in the last three months. A score of 0 means the participant did not.	Baseline, 3 months, 6 months