Tell Me More (Dime Mas)

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV, Mental Health Issue

Intervention / Treatment
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* Behavioral: Tell Me More (Dime Mas)
* Behavioral: Peer Ambassador Stories [Listen Miami (Oye Miami)]
* Behavioral: Standard Community Outreach


Participation Criteria
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Eligibility Criteria
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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 have not completed HIV testing in the past 3 months 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tell Me More (Dime Mas) group<br>Participants will get the Tell Me More (Dime Mas) program within up to 6 months. | Behavioral: Tell Me More (Dime Mas)<br>* 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.<br>Behavioral: Peer Ambassador Stories [Listen Miami (Oye Miami)]<br>* 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.<br>Behavioral: Standard Community Outreach<br>* Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.<br>|
| Experimental: Peer Ambassador Stories [Listen Miami (Oye Miami)] group<br>Participants will get the Peer Ambassador Stories [Listen Miami (Oye Miami)] within up to 6 months. | Behavioral: Peer Ambassador Stories [Listen Miami (Oye Miami)]<br>* 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.<br>Behavioral: Standard Community Outreach<br>* Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.<br>|
| Active Comparator: Standard Community Outreach group<br>Participants will receive standard community outreach within up to 6 months. | Behavioral: Standard Community Outreach<br>* Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |