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Tell Me More ("Dime Mas")

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06063083
Enrollment
90
Registered
2023-10-02
Start date
2024-01-12
Completion date
2026-04-20
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Mental Health Issue

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.

Interventions

BEHAVIORALTell 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.

BEHAVIORALPeer 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.

BEHAVIORALStandard Community Outreach

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

Sponsors

University of Miami
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in PrEP Engagement, as measured by the PrEP cascade questionnaireBaseline, 3 months, 6 monthsThis 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

MeasureTime frameDescription
Change in Behavioral Health Treatment Engagement, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)Baseline, 3 months, 6 monthsWe 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.
Change in Recent (within the last 3 months) HIV testingBaseline, 3 months, 6 monthsParticipants 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAudrey Harkness, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026