Tell Me More ("Dime Mas")

Not Applicable

Recruiting

• Conditions: Mental Health Issue; HIV

• Registration Number: NCT06063083
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-02
• Study Start: 2024-01-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PrEP Engagement, as measured by the PrEP cascade questionnaire	Baseline, 3 months, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Recent (within the last 3 months) HIV testing	Baseline, 3 months, 6 months	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.
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	We will use a modified version of the Psychosocial Treatment Inventory to assess participants' engagement with behavioral health treatment (inclusive of mental health or substance use treatment). This measure evaluates five "levels" of behavioral health treatment engagement (i.e., pre-contemplation, contemplation, preparation, action, and maintenance). We will evaluate this outcome as an ordered-categorical outcome.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States