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Completed

NCT Number: NCT06063083

Tell Me More ("Dime Mas")

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.

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Key information

Conditions

HIV Mental Health Issue

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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