## Protocol Section
### Identification Module
**NCT ID:** NCT06432725

**Brief Title:** Joining Under-connected Networks to Optimize "Salud" (Health) ("JUNTOS")

**Official Title:** 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

#### Organization Study ID Info
**ID:** 20230443
#### Organization
**Class:** OTHER
**Full Name:** University of Miami
#### Secondary ID Infos
**ID:** R34MH134670
**Link:** https://reporter.nih.gov/quickSearch/R34MH134670
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Miami

#### Responsible Party

**Investigator Affiliation:** University of Miami

**Investigator Full Name:** Audrey Harkness

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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).

### Conditions Module

**Conditions:**

- Hiv

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 245

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Behavioral: JUNTOS

**Label:** JUNTOS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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).

**Intervention Names:**

- Behavioral: Referral Sheet

**Label:** Referral Sheet - HIV test counselors

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- JUNTOS

**Description:** 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.

**Name:** JUNTOS

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Referral Sheet - HIV test counselors

**Description:** 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.

**Name:** Referral Sheet

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The number of Latino MSM participants who indicated using a biomedical HIV prevention/treatment.

**Measure:** Use of Biomedical HIV Prevention/Treatment

**Time Frame:** 3-months

**Description:** 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.

**Measure:** Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment

**Time Frame:** 3-months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment

**Time Frame:** 6-months

**Description:** This will be measured by a self-report question of Latino MSM's HIV status.

**Measure:** HIV acquisition, measures by self-report

**Time Frame:** 3-months

### Eligibility Module

**Eligibility Criteria:** 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 1 or more Latino MSM client per week (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 (\<80% fidelity)
* Willing and able to recruit 4-5 Latino MSM testing clients into the study

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 an HIV test from an HIV test counselor participating in the study
* 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aharkness@miami.edu

**Name:** Audrey Harkness, PhD

**Phone:** 786-401-2846

**Role:** CONTACT

**Contact 2:**

**Email:** nxa1040@miami.edu

**Name:** Nicole Altenberg, BS

**Phone:** 786-401-2846

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Coral Gables

**Contacts:**

***Contact 1:***

- **Email:** nxa1040@miami.edu

- **Name:** Nicole Altenberg, BS

- **Phone:** 786-401-2846

- **Role:** CONTACT

***Contact 2:***

- **Name:** Audrey Harkness, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Miami

**State:** Florida

**Zip:** 33146

#### Overall Officials

**Official 1:**

**Affiliation:** University of Miami

**Name:** Audrey Harkness, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
