HivNCT06432725
Joining Under-connected Networks to Optimize "Salud" (Health) ("JUNTOS")
A study testing JUNTOS and Referral Sheet in people with Hiv, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- JUNTOS and Referral Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Hiv
- Being tested
- JUNTOS, Referral Sheet
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUNTOSBehavioural
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.
Referral SheetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| JUNTOS | Experimental | 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). Receives: Behavioral: JUNTOS |
| Referral Sheet - HIV test counselors | Active comparator | 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). Receives: Behavioral: Referral Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Biomedical HIV Prevention/Treatment
The number of Latino MSM participants who indicated using a biomedical HIV prevention/treatment.
Measured: 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.
Measured: 3-months
Secondary outcomes (2)
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.
Measured: 6-months
HIV acquisition, measures by self-report
This will be measured by a self-report question of Latino MSM's HIV status.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start7 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- 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
- NCT06432725
- Sponsor's protocol ID
- 20230443
- Other IDs
- R34MH134670
- Status last verified
- Aug 2026
- First submitted
- 22 May 2024
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06432725
- Acronym / sponsor ID
- 20230443
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 May 2024 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUNTOS | Experimental | Behavioral: JUNTOSParticipants 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). |
| Referral Sheet - HIV test counselors | Active comparator | Behavioral: Referral SheetParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
- Unable to consent
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 |
|---|---|---|
| JUNTOSHIV 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. | Behavioural | JUNTOS |
| Referral SheetHIV 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. | Behavioural | Referral Sheet - HIV test counselors |
Primary outcome
Use of Biomedical HIV Prevention/Treatment
Time frame: 3-months
The number of Latino MSM participants who indicated using a biomedical HIV prevention/treatment.
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.
2 secondary outcomes
Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment
Time frame: 6-months
HIV acquisition, measures by self-report
Time frame: 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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 JUNTOS and Referral Sheet in people with Hiv, 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 13 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Use of Biomedical HIV Prevention/Treatment (time frame: 3-months). The study lists 2 primary outcomes in all. 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 27 Aug 2026.