Joining Under-connected Networks to Optimize "Salud" (Health) ("JUNTOS")

August 26, 2026 updated by: Audrey Harkness, University of Miami

Enhancing HIV Prevention and Treatment Referral and Engagement Among Latino Men Who Have Sex With Men (MSM): A Pilot Hybrid Effectiveness-Implementation Trial of the JUNTOS Referral Network

The objective of this study is to evaluate the JUNTOS Referral Network as an implementation strategy to enhance the reach of HIV-prevention and treatment services to Latino gay, bisexual, and other men who have sex with men (MSM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

HIV Test counselors:

  • 18 years of age or older
  • Certified as an HIV test counselor in Miami-Dade County or Broward County (at the time of enrollment)
  • Working or volunteering as an HIV test counselor in Miami-Dade County or Broward County and report testing 2 or more Latino MSM client per month (at the time of enrollment)
  • Plans to continue working or volunteering as an HIV test counselor in Miami-Dade County or Broward County for the next 6 months
  • Reports suboptimal fidelity to pre-exposure prophylaxis (PrEP) referral guidelines (<90% fidelity) and/or self-reports an unmet need for HIV prevention/treatment referral resources

Latino MSM:

  • 18 years of age or older
  • Identifies as Latino/a/x or Hispanic
  • Identifies as a sexual minority man or reports being a man who has sex with men
  • Speaks English and/or Spanish
  • Received a diagnostic HIV test from an HIV test counselor participating in the study or completed a diagnostic HIV test with a counselor in the last 3 months
  • Lives in Miami-Dade County, Broward County, or Palm Beach County and anticipates living there for the next three months

Exclusion Criteria:

HIV test counselors:

  • Unable to consent
  • Study personnel unable to verify HIV test counselor role in Miami-Dade County or Broward County (e.g., confirmation of where they work/volunteer as HIV test counselor, location they state they provide services doesn't exist or does not provide HIV testing services)
  • Works as an HIV test counselor in an incarceration/prison setting (i.e., clients are prisoners)

Latino MSM:

  • Unable to consent

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JUNTOS
Participants in this group will get access to the JUNTOS Referral Network website/app through the 6-month follow up (HIV test counselors) and 3-month follow up (Latino MSM).
Behavioral: JUNTOS
HIV test counselor and Latino MSM participants will be given access to the JUNTOS website/app, which shows information about local HIV and ancillary services. HIV test counselor participants will also be given access to a training video explaining how to use the JUNTOS website/app. HIV test counselors are encouraged to use the website/app for approximately 10 minutes at least once a week when meeting with Latino MSM testing clients. Latino MSM are encouraged to use the website/app to locate HIV and ancillary services as needed.
Active Comparator: Referral Sheet - HIV test counselors
Participants in this group will get access to the referral sheet through the 6-month follow up (HIV test counselors) and 3-month follow up (Latino MSM).
Behavioral: Referral Sheet
HIV test counselor and Latino MSM participants will be given access to referral sheet, which is a list of local HIV and ancillary services. HIV test counselors are encouraged to use the referral sheet for approximately 10 minutes at least once a week when meeting with Latino MSM testing clients. Latino MSM are encouraged to use the referral sheet to locate HIV and ancillary services as needed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Use of Biomedical HIV Prevention/Treatment
Time Frame: 3-months
The number of Latino MSM participants who indicated using a biomedical HIV prevention/treatment.
3-months
Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment
Time Frame: 3-months
The Referral Fidelity Questionnaire, developed for this study, has scores that range from 0% to 100%. Higher scores indicate more Latino MSM clients were referred to biomedical HIV Prevention/Treatment.
3-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment
Time Frame: 6-months
The Referral Fidelity Questionnaire, developed for this study, has scores that range from 0% to 100%. Higher scores indicate more Latino MSM clients referred to biomedical HIV Prevention/Treatment.
6-months
HIV acquisition, measures by self-report
Time Frame: 3-months
This will be measured by a self-report question of Latino MSM's HIV status.
3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230443
  • R34MH134670 (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

product manufactured in and exported from the U.S.

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.

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