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

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: Recruiting
• Conditions: Hiv
• Intervention / Treatment: Behavioral: JUNTOS; Behavioral: Referral Sheet

• Study Type: Interventional
• Enrollment (Estimated): 245
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey Harkness, PhD; Phone Number: 786-401-2846; Email: aharkness@miami.edu
• Study Contact Backup: Name: Jorge Limia, MS; Phone Number: 786-401-2846; Email: jml843@miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Principal Investigator: Audrey Harkness, PhD
      • Contact: Jorge Limia, MS; Phone Number: 786-401-2846; Email: jml843@miami.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Use of Biomedical HIV Prevention/Treatment	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	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

Outcome Measure	Measure Description	Time Frame
Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment	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	This will be measured by a self-report question of Latino MSM's HIV status.	3-months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Audrey Harkness, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID 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