HIVNCT06063083
Tell Me More ("Dime Mas")
A study testing Tell Me More ("Dime Mas"), Peer Ambassador Stories [Listen Miami ("Oye Miami")] and Standard Community Outreach in people with HIV and Mental Health Issue, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Mental Health Issue
- What is being tested?
- Tell Me More ("Dime Mas"), Peer Ambassador Stories [Listen Miami ("Oye Miami")] and Standard Community Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- HIV, Mental Health Issue
- Being tested
- Tell Me More ("Dime Mas"), Peer Ambassador Stories [Listen Miami ("Oye Miami")], Standard Community Outreach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tell Me More ("Dime Mas")Behavioural
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")]Behavioural
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 OutreachBehavioural
Participants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments.
| Study group | Role | What they receive |
|---|---|---|
| Tell Me More ("Dime Mas") group | Experimental | Participants will get the Tell Me More ("Dime Mas") program within up to 6 months. Receives: Behavioral: Tell Me More ("Dime Mas"); Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")]; Behavioral: Standard Community Outreach |
| Peer Ambassador Stories [Listen Miami ("Oye Miami")] group | Experimental | Participants will get the Peer Ambassador Stories [Listen Miami ("Oye Miami")] within up to 6 months. Receives: Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")]; Behavioral: Standard Community Outreach |
| Standard Community Outreach group | Active comparator | Participants will receive standard community outreach within up to 6 months. Receives: Behavioral: Standard Community Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PrEP Engagement, as measured by the PrEP cascade questionnaire
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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
Change in Behavioral Health Treatment Engagement, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)
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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start12 Jan 2024
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Audrey Harkness, University of Miami
- Investigators
- Audrey Harkness, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063083
- Sponsor's protocol ID
- 20201189
- Other IDs
- K23MD015690
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06063083
- Acronym / sponsor ID
- 20201189
- Conditions
- HIV, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tell Me More ("Dime Mas") group | Experimental | Behavioral: Tell Me More ("Dime Mas"), Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")], Behavioral: Standard Community OutreachParticipants will get the Tell Me More ("Dime Mas") program within up to 6 months. |
| Peer Ambassador Stories [Listen Miami ("Oye Miami")] group | Experimental | Behavioral: Peer Ambassador Stories [Listen Miami ("Oye Miami")], Behavioral: Standard Community OutreachParticipants will get the Peer Ambassador Stories [Listen Miami ("Oye Miami")] within up to 6 months. |
| Standard Community Outreach group | Active comparator | Behavioral: Standard Community OutreachParticipants will receive standard community outreach within up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tell 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. | Behavioural | Tell Me More ("Dime Mas") group |
| Peer 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. | Behavioural | Peer Ambassador Stories [Listen Miami ("Oye Miami")] group, Tell Me More ("Dime Mas") group |
| Standard Community OutreachParticipants will receive the standard community outreach, which will be a list of referrals for HIV testing, PrEP, and behavioral health treatments. | Behavioural | Peer Ambassador Stories [Listen Miami ("Oye Miami")] group, Standard Community Outreach group, Tell Me More ("Dime Mas") group |
Primary outcome
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.
2 secondary outcomes
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
Change in Recent (within the last 3 months) HIV testing
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Harkness, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tell Me More ("Dime Mas"), Peer Ambassador Stories [Listen Miami ("Oye Miami")] and Standard Community Outreach in people with HIV and Mental Health Issue, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PrEP Engagement, as measured by the PrEP cascade questionnaire (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.