Tell Me More ("Dime Mas")
April 27, 2026 updated by: Audrey Harkness, University of Miami
Addressing Latino Men Who Have Sex With Men (MSM) Health Disparities by Increasing Engagement With Behavioral and HIV Prevention Services: An Implementation Science Approach
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tell Me More ("Dime Mas") group
Participants will get the Tell Me More ("Dime Mas") program within up to 6 months.
|
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.
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.
Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.
|
|
Experimental: Peer Ambassador Stories [Listen Miami ("Oye Miami")] group
Participants will get the Peer Ambassador Stories [Listen Miami ("Oye Miami")] within up to 6 months.
|
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.
Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.
|
|
Active Comparator: Standard Community Outreach group
Participants will receive standard community outreach within up to 6 months.
|
Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PrEP Engagement, as measured by the PrEP cascade questionnaire
Time Frame: 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.
|
Baseline, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Recent (within the last 3 months) HIV testing
Time Frame: 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.
|
Baseline, 3 months, 6 months
|
|
Change in Behavioral Health Treatment Engagement, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)
Time Frame: 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.
|
Baseline, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Audrey Harkness, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2024
Primary Completion (Actual)
April 20, 2026
Study Completion (Actual)
April 20, 2026
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
October 2, 2023
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 20201189
- K23MD015690 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.